Vialis News

Acquisition of systems integrator Vialis brings expertise in delivering paperless laboratory solutions
SAN DIEGO, Jan. 14, 2013 – Accelrys Inc. (NASDAQ: ACCL), a leading provider of scientific innovation lifecycle management software, is solidifying its market leadership in the laboratory informatics space with the acquisition of its long-time partner Vialis AG, a leading systems integrator based in Liestal, Switzerland serving the pharmaceutical, biotechnology, chemicals, and agro-science industries. Vialis’ deep experience implementing and supporting paperless laboratory solutions further
strengthens Accelrys’ position in the laboratory informatics software market and expands the company’s capabilities in the downstream analytical development, quality control, and quality assurance and manufacturing areas. More here

Roche Penzberg wins the Facility of the Year award 2012
Instrument integration provided by Vialis is one of the key success factors!
Roche set out to double its capacity for Early Research and Technical Development of therapeutic proteins (TP expand project) at its Biotechnology site in Penzberg, Germany. Avoiding building a new facility, an innovative and well-engineered master plan has been created featuring six independent projects and a GMP IT system known as DAMAS. The DAMAS system is the key component that enables a high level of operational excellence at the Penzberg site. More here

Paperless lab Balance integration
Working in a paperless lab accelerates processes tremendously and relieve organizations from consuming documentation and control efforts. This movie shows how easy it is to work in a paperless environment using a balance. More here

24x7, free paperless lab networking service
You didn’t do it already? Signup for the paperless lab forum LinkedIn stream. Stay ahead of the curve and join the paperless lab forum LinkedIn stream. More here

Events

10th Annual PAT and Quality by Design
Date: Monday, March 18 – Wednesday, March 20 16:00, London, England
Workshop: Cheating is Allowed! - Leveraging Cross Industries Practices - presented by Peter Boogaard
- The mind-set and human factor critical to adopt best practices in both industries
- Cross-industry learning’s including deployment of PAT and QbD/6 sigma
- The changing role of the consumer interaction and how it may become part of the product life cycle
- What needs to be explored to eliminate informatics integration bottlenecks? 
  More information and Registration here

Paperless Lab Forum 13, 17 & 18-Apr-2013, Copenhagen Denmark
The Paperless Lab Forum 2013 gives you the unique opportunity to discover the enormous potential of paperless lab data management and meet the experts in person! Over 20 presentations and live demonstrations, you can quickly learn how the latest paperless solutions can revolutionize your lab processes. register now to get your free ticket. Please register at www.paperlesslabforum.com.For the latest agenda, hotel reservation or additional questions, please also visit the website.

Wie mache ich mein Analytiklabor 21 CFR Part 11 tauglich?
Donnerstag, 06-Jun-2013 (09:30 – 17:00)
Der korrekte Umgang mit computergestützten Systemen in Analytik und Qualitätskontrolle ist in den letzten Jahren in immer stärkerem Maß in den Mittelpunkt gerückt. Das Seminar „Wie mache ich mein Analytiklabor 21 CFR Part 11 tauglich?“ dient dazu, sich über aktuelle regulatorische und technische Entwicklungen zu informieren und sich in Bezug auf Vorgehensweisen zur Erfüllung regulatorischer Anforderungen auf den neuesten Stand zu bringen. Der Austausch mit anderen Teilnehmern erhöht das Spektrum an Informationen und vergrößert die Möglichkeiten zur Umsetzung der Anforderungen. Beispiele aus der Praxis und Erfahrungsberichte mit Behörden reichern das Seminar an. Mehr hier

„Laborprozesse Papierlos gestalten“ – Von der Idee bis zur Umsetzung
Datum: Donnerstag, 12-Sep-2013 (09:30 – 17:00)
Die in analytischen und Qualitätskontrolllaboratorien der chemischen und pharmazeutischen Industrie generierte Datenmenge steigt stetig, die Anforderungen an die Qualität der Daten werden sowohl von Seiten der Behörden als auch firmenintern immer höher, und die rasche Verfügbarkeit der Daten muss über Jahre hinweg – oft in nicht vorhergesehenen Zusammenhängen – garantiert sein. Dieses Seminar informiert Sie über die modernsten Trends und Möglichkeiten zur direkten elektronischen Erfassung und Handhabung von Daten und zeigt die regulatorisch korrekte Implementierung derartiger Systeme. Der Austausch mit anderen Teilnehmern erhöht das Spektrum an Informationen. Beispiele aus der Praxis und Videos von Life-Systemen reichern das Seminar an. Mehr hier

Concept Heidelberg organizes “ Pharma Lab Congress”
Date: 13 & 14-Nov-2013, Düsseldorf, Germany
The PharmaLab Congress will cover various topics in 10 interesting conferences and lectures on analytics, paperless lab, bio analytics, microbiology and R&D. 
More information and Registration here

Partner News

Accelrys’ Electronic Laboratory Notebooks Recognized in Gartner’s Enterprise Category
Breadth of ELNs rated Very High or High in Each Scientific and Functional Domain
SAN DIEGO, January 30, 2013 – Accelrys, Inc. (NASDAQ: ACCL), a leading provider of scientific innovation lifecycle management software, today announced that Gartner, Inc¬., the leading provider of research and analysis on the global information technology industry, has rated the company’s electronic laboratory notebooks (ELN) as “very high” or “high” in each scientific and functional domain in a recent report on considerations for selecting an ELN. Accelrys was the only vendor with ELNs that achieved those ratings in all categories. More here

Encounters

When data comes together by Peter Boogaard
The laboratory informatics landscape is changing, and a few changes have been made to the 2013 edition of the scientific computing world annual Laboratory Informatics Guide. When considering data integration, we must first stop thinking ‘technology’. Integration is not just about instruments or other software platforms. Instead, it is about integrating processes, accelerating ideas and facilitating mandatory compliance requirements more economically.
Topics covered:
• Data integration is not a goal on itself. How to set expectations and goals
• First things first - Importance of data standards
• Context is king - Importance of managing meta data
• Collaboration - Data intensive science is becoming mainstream. Here is why.
• Cheating is allowed - importance of adopting cross industry data integration practices
Download publication

A Look Ahead at BioPharma Manufacturing and Regulation
FDA talks about the changing scope of regulatory science.
Jan 1, 2013 - By: Angie Drakulich - BioPharm International - Volume 26, Issue 1, pp. 26-31
Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of regulatory science is a discipline that creates new tools, standards, and approaches for use in assessing the safety, effectiveness, quality, and performance of products.
In October 2010, FDA issued a framework for advancing regulatory science for public health, which focused on the following: accelerating delivery of new medical treatments; improving pediatric and children's health; protecting against emerging infectious diseases and terrorism; enhancing safety and health through informatics; protecting the food supply; modernizing safety testing; meeting challenges for regulating tobacco; and setting a collaborative implementation framework. More here

vialis AG • Kesselweg 40 • CH-4410 Liestal •
Tel: +41 61 813 01 78   • Fax: +41 61 813 01 79

Klicken Sie hier, falls Sie diesen Newsletter nicht weiter bekommen wollen.

Vialis News

Feedback of Paperless Lab Forum 12 in Basel
Over 110 delegates, 15 software and hardware vendors, 20 presentations, many live demonstrations, a paper versus paperless laboratory competition makes this Paperless Forum edition again to a successful event. The result of the survey gave some interesting result. 42% voted that the will going paperless will establish a self-documenting processes. Enabling cross functional collaboration between internal silo's was ranked 21%. Watch here the impressions of the 6th Paperless Lab forum in Basel and download the paperless lab white paper. Next Paperless Lab Forum 17 & 18 April 2013, Copenhagen

Join the Paperless Lab Forum on LinkedIn. Register here
Stream and network with peers. Recent discussion streams include…

• Mindset Change. CAPA should be replaced by PACA. Preventive thought processes, should prevail!
• STOP MANUAL TRANSCRIPTIONS. The scientist Is no longer in the laboratory, but integrated in the overall Quality process.
• Paperless Lab forum 2013 open. Register here. (URL)

Events

Don’t miss the opportunity to learn about IT compliance in a paperless lab.
14-Feb-2013, Linne Hotel Oslo
Vialis AG in partnership with Segalstad Consulting AS, will organize a one day compliance training course including practical information how to apply 21CFR part 11 compliance in a paperless laboratory. More information and registration here

Peter Boogaard chairs the Smart Lab 2013 Exchange
26 – 27-Feb-2013 Hilton Munich Park Hotel Munich.
This year’s theme is Doing more with less: How to get products to market faster and cheaper. 15% discount is available until December 7!  Request for 15% discount

More Information, Registration and Impressions of 2012 edition here or request an invitation here

2013 edition of Paperless Lab Forum goes north! 17-18-Apr-2013 Copenhagen
The Paperless Lab forum provides the ideal learning platform for those considering or enhancing modern Paperless lab innovation initiatives. Paperless Lab is not just about implementing more soft- and hardware technology. The latest technology developments, practical conceptual approaches and customer presentations, to drive effective Paperless Lab initiatives were presented. Thanks to our event sponsors, we are able to offer you, this high quality Paperless Lab Forum without any entry fee. Register at www.paperlesslabforum.com

10th PAT and Qualty by Design  conference 18-20-Mar-2013 London
Save Money, Improve Standards and Increase Efficiency by Cost-Effectively Implementing PAT and Quality by Design. Attend the “cheating is allowed – leveraging cross industry practices” workshop or discuss why CAPA should be replaced by PACA.

Partner News

New Informatics Platform for QA/QC Laboratories
PerkinElmer Informatics is pleased to announce the newest release of the iLAB™ informatics platform, a suite of integrated solutions that meet the specific needs and challenges of QA/QC laboratories. More here

Accelrys Adds Another Scientific Software Company to Its Portfolio
After merging with Symyx Technologies in 2010, acquiring Contur Sofware in 2011, and buying VelQuest earlier this year, San Diego scientific software developer Accelrys (Nasdaq: ACCL) says today it is buying Aegis Analytical. More here

Integrated Systems:  Data Management - Data Management for Next Generation Pharma and Biotech Formulations
Use of archived data in an integrated system helps reduce cycle times and costsThe formulation of active pharmaceutical ingredients or new molecular entities, along with associated analytical test methods, is integral to a new drug’s development and commercialization plan. In fact, the formulation research can “make or break” the commercial viability of any new medicine. A critical milestone along the commercialization path is the development of an optimized formulation that meets the therapeutic needs of the patient and the production/commerciali­zation needs of the pharma/biotech manufacturers. More here

Partner News

Facing Cross Industry Challenges in the Food and pharma – Scientific Computing
Food companies are becoming pharma companies. Pharma-foods, the intersection between food and pharmaceuticals, represent an area of growing opportunities for the food sector. Developing pro-active approach adapting QbD as a standard model and implementing new tools such as PAT, KQI and CQA  will leverage learning’s from both industries. Agile processes integrating “intelligent Equipment” will result in a new system-landscape allowing a seamless dataflow from start-to-end. Full Article

The De-Evolution of Informatics
How externalization workflow is impacting traditional data management architectures
The challenges of the pharmaceutical industry to generate new molecular entities while controlling expenses have been well-documented. With over 75 percent of U.S. drug sales now coming in the form of generic equivalents, new models must be tried to stimulate ideation and increase the candidate Pipeline. In the last several years, the desire to externalize research and development has been one of the models in vogue. The belief is that an atmosphere of innovation can be created, while at the same time lowering fixed costs. Partnering with contract organizations, academic institutions and other pharmaceutical companies can “virtualize” discovery and enable global collaboration. As is often the case, the devil is in the details; the information architectures required to allow the seamless flow of data between these multiple entities lag far behind the progression of the business model. More here

vialis AG • Kesselweg 40 • CH-4410 Liestal •
Tel: +41 61 813 01 78   • Fax: +41 61 813 01 79

Klicken Sie hier, falls Sie diesen Newsletter nicht weiter bekommen wollen.

Vialis News

Paperless Lab offering extended to include QbD (Quality by Design)

Vialis AG and Industrial Lab Automation are proud to announce to join forces to strengthen their European consulting offerings. “Driven by strong demand from northern European customers the strengthening of our presence in that area is just a logical consequence”, says Ulf Fuchslueger, CEO of Vialis, “additionally, supported by recent regulatory developments we see QbD complementing our Paperless Lab offering for the benefit of our customers”. More here

Effizienzschub für Unternehmen
Papierloses Labor hilft, Herausforderungen in Forschung, Entwicklung und Qualitätskontrolle zu meistern. Labors für Entwicklung und Qualitätskontrolle in der pharmazeutischen Industrie befinden sich in einem immer stärker ausgeprägten Spannungsfeld zwischen regulatorischen und wirtschaftlichen Anforderungen. Um diesen Anforderungen zu genügen, sind neue Wege des Prozess-, Daten- und Systemmanagements nötig. Das Papierlose Labor, verstanden als ganzheitliche Prozessinitiative, nicht als Systemeinführung, kann nicht nur diese Herausforderungen meistern, sondern darüber hinaus auch einen nachweisbaren Effizienzschub für Unternehmen leisten. Mehr hier.

Join the Paperless Lab Forum on LinkedIn. Register here    

Events

Paperless Lab Forum 2012:  25-Oct-2012 (09:00 – 17:00), Basel
Are you ready for the paperless future?
This is your chance to discover the enormous potential of paperless lab data management. The benefits of going paperless are considerable: you can easily generate high quality data, increase and improve compliance, work directly with raw data and securely store and distribute data. That means far more flexibility, efficiency and productivity for your business.
With live demonstrations from leading paperlesslab providers and users, you can see for yourself what fits your needs and meet the experts in person. Find out what the very latest in paperless lab solutions have to offer – from barcodes, ELN, LIMS and environmental monitoring to instrument interface and business intelligence systems. More information and registration here.

QbD & PAT - The Scientist Is No Longer In The Laboratory, But Integrated In The Overall Quality Process
This webinar will highlight how QbD / PAT and Paperless Lab processes enables organizations to create start-to-finish knowledge management repository to adopt cross functional collaboration between management, scientists and engineers responsible for products in development and manufacturing, processes, equipment and facilities. More here

Vialis presents and demonstrates paperless lab solution and is hosting the QbD forum Thermo Scientific Informatics World Europe. 16-19-OCT-2012, Amsterdam Marriott Hotel. More here.

Vialis auf dem LIMS Forum in Bonn 06-Nov-2012  bis 07-Nov-2012 in Bonn
Was wird vermittelt? Aktueller Stand der Technik • Dialog mit Experten, Anwendern und Anbietern • Einsatzmöglichkeiten, Kosten und Nutzen • Tipps zur Auswahl und Implementierung • Anwendererfahrungen aus LIMS-Projekten • IT-Validierung • Archivierung • Aktuelle LIMS-Marktübersicht • Absehbare Trends. Mehr hier

Das Papierlose Labor – Klinkner & Partner - Donnerstag, 08-Nov-2012 (10:00 – 17:30) Bonn
Referent Andreas Schild Senior Consultant Vialis AG
Die in analytischen und Qualitätskontrolllaboratorien der chemischen und pharmazeutischen Industrie generierte Datenmenge steigt ebenso stetig wie die Anforderungen an die Qualität und Verfügbarkeit dieser Daten. Dieses Seminar informiert Sie über die modernsten Trends und Möglichkeiten zur direkten elektronischen Erfassung und Handhabung von Daten und zeigt die regulatorisch korrekte Implementierung derartiger Systeme. Beispiele aus der Praxis runden das Seminar ab. Mehr hier

Peter Boogaard Director of Vialis chairs the Smart Lab 2013
26 – 27_Feb-2013 Hilton Munich Park Hotel Munich
More Information, Registration and Impression of 2012 edition here 

Partner News

Thermo Fisher Scientific Named Company of the Year for Integrated Biobanking Solutions by Frost & Sullivan
Mountain View, CA (June 12, 2012) - Thermo Fisher Scientific Inc., the world leader in serving science, today announced that Frost & Sullivan recently named it the company of the year for integrated biobanking solutions. After extensive analysis of the biobanking market, Frost & Sullivan concluded that there are currently no other market participants with such a diverse and cutting-edge portfolio of products, services and solutions for the biobanking industry. Organizations that take advantage of the rapidly growing set of Thermo Scientific tools and technologies aimed at biobanks and biorepositories reap the benefits of enhanced sample integrity, tracking and audit trail. More here.

Accelrys ELN Advances Innovation Lifecycle Management with Enhanced Biology Capabilities from Screening to Preclinical Development
SAN DIEGO, Aug. 28, 2012 /PRNewswire/ -- Accelrys, Inc. (NASDAQ: ACCL), a leading provider of scientific innovation lifecycle management software, has announced that the latest release of the company's enterprise electronic laboratory notebook (ELN), Symyx Notebook by Accelrys, offers a new multidimensional scientific spreadsheet for use in planning, executing and tracking a wide range of biological experiments. In addition, powerful new project tracking and optimization software provides a more complete biology solution, from efficient study orchestration to study execution in the lab. Together, the new ELN capabilities accelerate scientific innovation lifecycle management across a range of chemical and biological experimentation, helping bridge the productivity gap from innovation through commercialization. More here.

Encountered

The Glue to Build Enterprise Knowledge by Peter Boogaard - July/Aug 2012 - Scientific Computing
It is time to put more emphasis on the preventing facet and re-order the sequence of the CAPA abbreviation into PACA. We now can turn our potential data graveyards into valuable resources to facilitate the QbD promise across the pharmaceutical Quality System model. It is proven that his theory to adopt continuous improvement strategies to decrease variability resulted in significantly better products and financial performance. Full Article

ELN and the iPad Mike Elliot, August 2012 Scientific Computing
Tablets and ELN A Honeymoon by Mike Elliot, August 2012 Scientific Computing
The explosive growth of tablet computing has taken many by surprise, and vendors are starting to test the waters. Since the early days of electronic laboratory notebook (ELN) technology, many have dreamt of a paper notebook replacement that is truly portable, transforms handwriting,and is suitable for a laboratory environment. - Full Article

vialis AG • Kesselweg 40 • CH-4410 Liestal •
Tel: +41 61 813 01 78   • Fax: +41 61 813 01 79

Klicken Sie hier, falls Sie diesen Newsletter nicht weiter bekommen wollen.

Vialis News

New Article: Introducing a Paperless Lab
How optimization and simultaneous electronic support of actual laboratory processes can boost efficiency

Laboratories working in the pharmaceutical industry in the areas of R&D and quality control find themselves increasingly having to cope with conflicting demands — tougher regulatory requirements and harsher economic realities. In order to meet these demands, new ways of dealing with process, data and system management are necessary. This article shows how the paperless lab (as an integrated process, and not as a system implementation) can meet these challenges and boost efficiency. More here

Events

„Laborprozesse Papierlos gestalten“ – Von der Idee bis zur Umsetzung: 06-Sep-2012 Basel
Das Seminar gibt einen detaillierten Überblick über die modernsten Lösungen zur papierlosen Arbeitsweise in analytischen Laboratorien. Planung, technische Anforderungen und die Einführung regulatorisch kompatibler Lösungen basierend auf modernster LIMS-Technologie werden diskutiert und präsentiert. Dass es sich beim papierlosen Labor nicht um unerfüllte Träume handelt, wird anhand von Umsetzungsbeispielen aus der Praxis und Videos demonstriert.
Kursinformationen

Paperless Lab Forum 2012:  25-Oct-2012 (09:00 – 17:00), Basel
Are you ready for the paperless future?
This is your chance to discover the enormous potential of paperless lab data management. The benefits of going paperless are considerable: you can easily generate high quality data, increase and improve compliance, work directly with raw data and securely store and distribute data. That means far more flexibility, efficiency and productivity for your business.
With live demonstrations from leading paperlesslab providers and users, you can see for yourself what fits your needs and meet the experts in person. Find out what the very latest in paperless lab solutions have to offer – from barcodes, ELN, LIMS and environmental monitoring to instrument interface and business intelligence systems. More information and registration here.

Vialis auf dem LIMS Forum in Bonn 06-Nov-2012  bis 07-Nov-2012 in Bonn
Was wird vermittelt? Aktueller Stand der Technik • Dialog mit Experten, Anwendern und Anbietern • Einsatzmöglichkeiten, Kosten und Nutzen • Tipps zur Auswahl und Implementierung • Anwendererfahrungen aus LIMS-Projekten • IT-Validierung • Archivierung • Aktuelle LIMS-Marktübersicht • Absehbare Trends. Mehr hier

Das Papierlose Labor – Klinkner & Partner - Donnerstag, 08-Nov-2012 (10:00 – 17:30) Bonn
Referent Andreas Schild Senior Consultant Vialis AG
Die in analytischen und Qualitätskontrolllaboratorien der chemischen und pharmazeutischen Industrie generierte Datenmenge steigt ebenso stetig wie die Anforderungen an die Qualität und Verfügbarkeit dieser Daten. Dieses Seminar informiert Sie über die modernsten Trends und Möglichkeiten zur direkten elektronischen Erfassung und Handhabung von Daten und zeigt die regulatorisch korrekte Implementierung derartiger Systeme. Beispiele aus der Praxis runden das Seminar ab. Mehr hier

Partner News

Sartorius - CUBIS individual – durch integrierte Workflows mehr Sicherheit und Effizienz im Pharmalabor
Auf der Achema 2012 stellt Sartorius das neue CUBIS individual Produktkonzept vor.
Es handelt sich dabei um die Integration von individuellen Workflows (SOP´s) in CUBIS Labor Waagen. Dies wird kundenspezifisch durchgeführt, so dass jede SOP  so umgesetzt wird  wie sie beschrieben ist, ohne Kompromisse. Mehr hier

Accelrys - Informatics-Driven Quality by Design for Drug Development
The Pharmaceutical industry has been slow to adopt the regulatory Quality by Design (QbD) guidelines. However, leaner times are forcing Pharmas to change and optimize business practices.
QbD principles focus on better understanding the process and product attributes that affect product quality. In so doing, they provide regulatory and business opportunities for companies that are striving to improve product quality and performance through the use of more effective, efficient and robust processes that bridge the entire product development cycle. Informatics has been a key enabler and forerunner of QbD in other industries. A QbD strategy for Pharma supported by modern Informatics offers significant opportunities to lower compliance costs and improve product quality while delivering better therapeutic products, faster and at lower cost to patients. This whitepaper explores the Informatics journey and its role in driving QbD adoption within drug development. More here

Encountered

Informatics Engine Drives Pharma Development toward Quality by Design. By Peter Boogaard
The pharmaceutical industry is looking more at holistic approaches to improve the process of bringing new products to market. Adopting these approaches can accelerate product development while lowering operational costs. Quality by Design (QbD) has come relatively late to the pharmaceutical industry. For years, other industries, including the automobile, aviation and food & beverage industries, have adopted, very successfully, six Sigma QbD philosophy. The international Conference on Harmonisation (ICH) rolled out its first framework for QbD concept for pharmaceutical Development in 2003. More here

Integrating Informatics and High-Content
Screening to Find a Cure for Spinal Cord Injury: Selecting a LIMS for CNS Regeneration
The Miami Project to Cure Paralysis, part of the University of Miami Miller School of Medicine, includes a laboratory devoted to high-content screening (HCS) of neurons. The laboratory is run by Vance Lemmon and John Bixby, hence, the LemBix laboratory. The goal of the laboratory is to uncover signaling pathways, genes, compounds, or drugs that can be used to promote nerve growth.
HCS of various libraries on primary neurons requires a team-based approach, a variety of process steps, and complex manipulations of cells and libraries to obtain meaningful results. The approach of HCS itself produces huge amounts of data in the form of images, well-based and cell-based  phenotypic measures. A single experiment can generate data from 300,000 neurons with 120 parameters per cell. Managing sample work flow and library data, along with the vast amount of experimental results, is challenging. The laboratory is currently implementing an informatics solution to meet the ever-growing data deluge and to turn data into knowledge. More here

vialis AG • Kesselweg 40 • CH-4410 Liestal •
Tel: +41 61 813 01 78   • Fax: +41 61 813 01 79

Klicken Sie hier, falls Sie diesen Newsletter nicht weiter bekommen wollen.

Vialis News

New Article: The Paperless Lab

Laboratories working in the pharmaceutical industry in the areas of R&D and quality control find themselves increasingly having to cope with conflicting demands – tougher regulatory requirements and harsher economic realities. In order to meet these demands, new ways of dealing with process-, data- and system management are necessary. This article shows how the paperless lab (as an integrated process, not as a system implementation) can meet these challenges and boost efficiency.
More here

Events

Pharma QbD Forum 2012:  24-25-Apr-2012, Berlin
QbD offers countless benefits, but obstacles still remain as drug companies struggle to fully understand and respond to regulatory uncertainty. This event is for pharma companies considering or already on the QbD trajectory, and provides pragmatic approaches to QbD implementation in a GMP environment.
More here

SmartLab Exchange: 05-07-Mar-2012
Meet us at the SmartLab Exchange the 05 - 07 of March, 2012 Hotel le Plaza, Brussels
More here

Experte für Qualitätskontrolle/Quality Unit: 06-08-Mar-2012 in Hotel am Sophienpark, Baden-Baden
Mehr hier

IIR-Konferenz "Labore 2012" 12-14- Mar-2012, Wien
• Bewegen Sie sich rechtsicher im Labor – Wie Sie Vorschriften richtig ein- und umsetzen
• Fokus Validierung/ Qualifizierung: Standortbestimmung im Spannungsfeld Behörde – Anwender
• LIMS: Kosteneffizienz, -effektivität und Nutzen – Benchmarks unterschiedlicher Systeme
• Labor-Akkreditierungen und/oder –Zertifizierung: So kommen Sie zu Ihrer Berechtigung
 Mehr Informationen und Anmeldung: Hier

Wie mache ich mein Analytiklabor 21 CFR Part 11 tauglich? 06-Jun-2012, Basel
Das Seminar erläutert die aktuellste regulatorische Sichtweise und Interpretation in Bezug auf computergestütze Systeme (u.a. 21 CFR Part 11, EU GMP Annex 11 Draft), erläutert die Vorgehensweise zur Implementierung von validierten Computersystemen – speziell auch in Bezug auf Neuerungen aus GAMP5 - und beschreibt unter anderem den Umgang mit 21 CFR Part 11 inkompatiblen Softwarelösungen aus praktischer Sicht. Die Aufrechterhaltung des validierten Zustands von Computersystemen und zugehöriges Change Management werden ebenfalls behandelt.
Kursinformationen

„Laborprozesse Papierlos gestalten“ – Von der Idee bis zur Umsetzung: 06-Sep-2012 Basel
Das Seminar gibt einen detaillierten Überblick über die modernsten Lösungen zur papierlosen Arbeitsweise in analytischen Laboratorien. Planung, technische Anforderungen und die Einführung regulatorisch kompatibler Lösungen basierend auf modernster LIMS-Technologie werden diskutiert und präsentiert. Dass es sich beim papierlosen Labor nicht um unerfüllte Träume handelt, wird anhand von Umsetzungsbeispielen aus der Praxis und Videos demonstriert.
Kursinformationen

Paperless Lab Forum 2012:  25-Oct-2012 (09:00 – 17:00), Basel
The Paperless Lab Forum is the ideal opportunity to increase your knowledge and awareness of the Paperless Lab. Live demonstrations and Presentations of this forum provides the opportunity to get to know the vendors who are currently providing parts and pieces of a paperless lab process.
More information and Registration here.

Partner News

Oracle How can Life Science companies comply with the upcoming guidelines for serialization and successfully fight counterfeit products?
As a result of counterfeit drugs and medical devices entering the distribution supply chain and endangering patient safety, many healthcare and life sciences organizations are facing increased supply chain and brand integrity risks. Analysts estimate that counterfeit and diverted drugs, as well as drug recall, cost the industry between $30B and $100bn annually.
More here

Industrial Labautomation - Success through Process Optimization
Laboratory operations are characterized by high degree of diversity, complexity and interdependence. Specialized Multi Moment Analysis is are commended first step to find laboratory bottlenecks before identify the best strategies to bridge silos between R&D and manufacturing laboratory operations.
More here

Accelrys Acquires Velquest Corporation
This acquisition extends Accelrys’ reach downstream in the lab-to-market value chain with addition of industry-leading lab execution and data capture software.
More here

Master Control 21 CFR Part 11 - Are You Ready for an FDA Inspection?
The U.S. Food and Drug Administration (FDA) issued 21 CFR Part 11 in 1997 to establish criteria for the use of electronic records and electronic signatures by organizations that comply with the federal Food, Drug, and Cosmetic Act and the Public Health Service Act. Part 11 applies to all FDA-regulated companies, such as pharmaceutical, medical device, biotech, blood, and biologics companies, and contract research organizations.
More here

Serena - Orchestrating Your Requirements Process
How to Stay in Control and Keep Development Efficient When Everyone Isn’t Completely Agile.
More here

Thermo Fisher Scientific Showcases End-to-End Solutions for Biobanks and Biorepositories at ESBB 2011
PHILADELPHIA, PA (November 1, 2011) - Thermo Scientific solutions address the unique and complex needs of biobanks and biorepositories while offering scalability and efficiency to organizations of all sizes, from university research labs to contract research organizations, laboratories and large-scale pharmaceutical and biotechnology facilities. The company delivers the software, equipment, consumables, reagents and services to provide the end-to-end solution required for today’s rapidly changing organizations.
More here

Encountered

Sinn und Zweck der Computerized Systems Validation
(Dr. Thomas Karlewski;  Managing Consultant Information Systems; Chemgineering – The Business Designers)
CSV mit Bildern einmal anders erklärt
Ein Versuch, die Bedeutung der CSV – Computerized Systems Validation – und ihrer Aktivitäten in einem IT/ERP-Projekt jemandem zu erklären, der niemals zuvor mit den regulatorischen Aspekten eines computergestützten Systems und seiner Einführung in einer pharmazeutischen Umgebung zu tun hatte.
Mehr hier

Informatics Convergence Presents Opportunities and Challenges
The future of ELN will require innovative and disruptive thinking
Technology convergence — it is happening all around us in the consumer world where
smartphones consolidate diaries, calendars, messaging systems and phones into a single platform. In the last two years, mobile devices, such as the iPad, have converged most of the smartphone functionality into a thin, mobile — yet simple to use — computing platform. App stores provide the freedom users need to make individual choices of software solutions. No longer do consumers have to be beholden to monolithic applications that are difficult to install, support and use.
More here

vialis AG • Kesselweg 40 • CH-4410 Liestal •
Tel: +41 61 813 01 78   • Fax: +41 61 813 01 79

Klicken Sie hier, falls Sie diesen Newsletter nicht weiter bekommen wollen.

Vialis News

Paperless Lab Forum Review

Once again the Paperless Lab conference goes from strength to strength: an oversubscribed meeting, well supported by application vendors and fast becoming the lab informatics event of the year. The unique value of this event is the combination of adding a systems integrator like Vialis to a wide ranging combination of science industry experts and scientific software providers around a compelling narrative of a transformational business initiative dubbed ‘The Paperless Lab’. Impression here

SmartLab Exchange
Vialis is currently valued member of the Smart Labs Exchange advisory board, an invitation-only Director’s forum which offers 60+ CIOs, R&D Heads, and QA/QC Directors the opportunity to discuss strategies, solutions and best practice for creating smart labs. More here

Events

2-Day Intensive CAPA/Quality Event Management Training
Date: 15 and 16 February 2012
Location: Allschwil, Switzerland
You’ll learn from the very best—seasoned quality and compliance professionals who’ve trained investigators from hundreds of regulated life science and manufacturing organizations worldwide. Register today—and discover how an effective CAPA system can reduce your manufacturing costs, minimize product recalls and ensure product safety and effectiveness! More here

SmartLab Exchange
Meet us at the SmartLab Exchange the 05 - 07 of March, 2012 Hotel le Plaza, Brussels More here

Partner News

Oracle:
Combating Counterfeit Medicine:
Enabling Mass Serialization and Pedigree Management in The Pharmaceutical Industry
International trade in counterfeit medicines is rapidly increasing, presenting serious risks to public health around the world. To ensure patient safety, pharmaceutical manufacturers urgently need to find ways to protect the integrity of their own products and keep counterfeit medicines out of the legitimate supply chain. While individual countries and US states have started to build local legislative frameworks to address the problem, there is currently no standardized regional or global approach to preventing trade in illegitimate drugs. Pharmaceutical manufacturers must therefore move to protect their supply chains in the absence of a single set of regulatory standards. More here

Accelrys:
Implementing Electronic Lab Notebooks How do you define and manage success? By Bennett Lass Ph.D , PMP
In the past five years, the electronic lab notebook (ELN) has moved from nascent technology deployed mainly by early adopters and technology enthusiasts to a mainstream laboratory chemical informatics platform. Atrium Research and Consulting estimates that over 25% of the potential market for ELNs has either deployed or is in the midst of deploying an ELN, with larger organizations of over 500 users comprising the bulk of these deployments. More here

Thermo Fisher Scientific:
Thermo Fisher Scientific Showcases End-to-End Solutions for Biobanks and Biorepositories at ESBB 2011
Thermo Fisher Scientific Inc., the world leader in serving science, will showcase its turnkey biobanking solution within booths 13 and 14 at ESBB 2011, taking place from November 16-19, in Marseille, France. This comprehensive solution set ensures sample quality and addresses the complete biobanking workflow including biospecimen collection, processing, testing and storage, as well as sample and data management.
Visit www.thermoscientific.com/biobankingresources for further information.

Thermo Scientific Integration Manager - Paperless Laboratory Workflow
With the introduction of new electronic solutions over the years, laboratories have gained efficiency and security over their formerly paper-based solutions. The ability to pass information between laboratory instrumentation and other enterprise systems, enabling information sharing and connectivity across an organization – is perhaps one of the greatest gains attributed to the evolution of informatics in the laboratory. Laboratories stand to gain the most value from their software solutions if they are fully integrated with each other, and with the other enterprise systems and instrumentation, bringing real-time information to management at all levels of the organization. Thermo Scientific Integration Manager provides the key to enabling comprehensive integration throughout the laboratory by turning data into powerful and relevant information. Visit http://www.youtube.com/watch?v=1hlHcyyyNKw to learn about the capabilities of the most recent version of Integration Manager and how the tool is integral in the creation of a paperless laboratory workflow.

Encountered

Latest weather forecast: More clouds on the horizon…
Cloud collaboration has allowed projects of previously unimaginable scale and scope to be constructed at an unmet price/performance ratio. Widespread access to Information and Communication Technologies (ICTs) and agile and adaptable systems of workflow now allow people across the globe to collaborate on virtual mega-engineering projects that are unprecedented in scale or scope (Ref M Graham – Engineering Earth, 2011 – geospace.co.uk) More here

vialis AG • Kesselweg 40 • CH-4410 Liestal •
Tel: +41 61 813 01 78   • Fax: +41 61 813 01 79

Klicken Sie hier, falls Sie diesen Newsletter nicht weiter bekommen wollen.

Events

Laborprozesse Papierlos gestalten – Von der Idee bis zur Umsetzung:
Donnerstag, 01-Sep-2011
Die in analytischen und Qualitätskontrolllaboratorien der chemischen und pharmazeutischen Industrie generierte Datenmenge steigt stetig, die Anforderungen an die Qualität der Daten werden sowohl von Seiten der Behörden als auch firmenintern immer höher, und die rasche Verfügbarkeit der Daten muss über Jahre hinweg – oft in nicht vorhergesehenen Zusammenhängen – garantiert sein. Dieses Seminar informiert Sie über die modernsten Trends und Möglichkeiten zur direkten elektronischen Erfassung und Handhabung von Daten und zeigt die regulatorisch korrekte Implementierung derartiger Systeme. Der Austausch mit anderen Teilnehmern erhöht das Spektrum an Informationen. Beispiele aus der Praxis und Videos von Live-Systemen reichern das Seminar an. Mehr hier

Klinkner Seminar: Das papierlose Labor:
Donnerstag, 29-Sep-2011
Das Seminar gibt einen detaillierten Überblick über die modernsten Lösungen zur papierlosen Arbeitsweise in analytischen Laboratorien. Planung, technische Anforderungen und die Einführung regulatorisch kompatibler Lösungen basierend auf modernster LIMS-Technologie werden diskutiert und präsentiert. Mehr hier

Paperless Lab and Bio-banking:
Vienna, Wednesday, 12-Oct-2011
This Seminar provides a chance to share industry perspectives and changing business requirements that drive the delivery of Integrated, Combined and Comprehensive Solutions. Both we and customers like to share information about the benefits of these Integrated Solutions with a Paperless Lab Approach and the latest Informatics approach in Bio-banking all supported by LPG products and solutions, e.g. Laboratory Consumables and Equipment. We will continue our tradition of customer involvement by hosting product breakout sessions which include customer presentations. More information and registration here

Paperless Lab Forum 2011:
Basel, Thursday, 27-Oct-2011
The Paperless Lab Forum is the ideal opportunity to increase your knowledge and awareness of the Paperless Lab. Live demonstrations and Presentations of this forum provides the opportunity to get to know the vendors who are currently providing parts and pieces of a paperless lab process. More information and registration here

Automation in pharmaceutical industry
Leiden, NL, Tuesday, 11-Oct-2011,
Technology and Business Trends in R&D, Pilots, Upscaled Production & Distribution The pharmaceutical and life science community in Belgium and the Netherlands will gather on 11 October in the Holiday Inn Leiden for its biannual event ‘Automation in Pharmaceutical Industry’. The conference programme will highlight technology and business trends in R&D, pilots, upscaled production and distribution, including speakers from ING, Merck, Crucell, Wageningen UR, Genth University, Synthon and Prosensa. More information and registration here

Partner News

Labtronics Whitepaper: Why do so Many People still not use a LIMS?
LIMS have been around for many years as the standard informatics system found in many laboratories. Why is it then that a lot of labs have not bought a LIMS? Does a LIMS not meet their needs? Are there better options? This article will explore some of these questions and look at alternatives to a LIMS. More here

Accelrys Case Study: Implementing and using an ELN in validated environments
“We observed a greater than 50% time savings on documentation...”
One of the primary challenges in implementing an electronic lab notebook (ELN) is getting buy-in from the myriad stakeholders who interact with the experimental data being recorded. Nowhere is this challenge more pronounced than in validated environments such as analytical GxP testing and GMP manufacturing. In these areas, the need to comply with strict regulatory mandates about how methods, processes, and testing are documented and validated has led to even stricter internal controls that are codified in entrenched, paper-based workflows. More here

Velquest Whitepaper: Thin LIMS, Thick LIMS — New IT
Implementation Strategy for cGMP Quality Informatics How to complete a QC/QA cGMP lab IT architecture with half the technical resources in half the time. More here

Encountered

New Debates on Intellectual Property Protection and ELN
By Michael H Elliott Atrium Research & Consulting LLC For the first five years of the “modern” age of ELN, people deliberated the capabilities of ELN to support intellectual property (IP) at various seminars and conferences. Questions such as “How can ELN protect intellectual property? Are ELN admissible into court?” were extensively discussed. In those days, large pharmaceutical companies a majority of the early adopters of the technology and the majority of the overall ELN customer base had the greatest concerns. More here

MANUAL OF POLICIES AND PROCEDURES CENTER FOR DRUG EVALUATION AND RESEARCH
Applying ICH Q8(R2), Q9, and Q10 Principles to CMC Review This MAPP outlines and clarifies how the chemistry, manufacturing, and controls (CMC) reviewers in the Office of Pharmaceutical Science (OPS) should apply the recommendations in the ICH Q8(R2), Q9, and Q10 guidances to industry. More here

vialis AG • Kesselweg 40 • CH-4410 Liestal •
Tel: +41 61 813 01 78   • Fax: +41 61 813 01 79

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Vialis News

Vialis opens Office in the UK
After 8 years of successful operation in central Europe Vialis AG increases its global reach with the creation of a new subsidiary in the UK. The UK office located close to Nottingham will bring the renowned level of competency and services to our customers in the UK and Scandinavia. Vialis is proud to announce that it has recruited Stephen Yemm as Managing Director of Vialis Ltd. Stephen has long standing experience in the domain of lab data management and solutions to support the automation of lab processes and as such is well positioned to drive Vialis operations in northern Europe. More here

Events

Wie mache ich mein Analytiklabor 21 CFR Part 11 tauglich?
Donnerstag, 16-Jun-2011
Der korrekte Umgang mit computergestützten Systemen in Analytik und Qualitätskontrolle ist in den letzten Jahren in immer stärkerem Maß in den Mittelpunkt gerückt. Das Seminar „Wie mache ich mein Analytiklabor 21 CFR Part 11 tauglich?“ dient dazu, sich über aktuelle regulatorische und technische Entwicklungen zu informieren und sich in Bezug auf Vorgehensweisen zur Erfüllung regulatorischer Anforderungen auf den neuesten Stand zu bringen. Der Austausch mit anderen Teilnehmern erhöht das Spektrum an Informationen und vergrößert die Möglichkeiten zur Umsetzung der Anforderungen. Beispiele aus der Praxis und Erfahrungsberichte mit Behörden reichern das Seminar an. Nur noch wenig Plätze frei. Mehr hier

VelQuest Corporation and Vialis cGxP Informatics “Lunch and Learn” Seminar/Workshop
Tuesday the 28th of June in Frankfurt
“Operational Excellence from Lab to Plant” Join us for an informative seminar/workshop on VelQuest’s award-winning Procedure Execution Management products for the cGxP QC Lab and Plant Batch Record needs for 21st century life science operations. More here

Laborprozesse Papierlos gestalten – Von der Idee bis zur Umsetzung: Donnerstag, 01-Sep-2011
Die in analytischen und Qualitätskontrolllaboratorien der chemischen und pharmazeutischen Industrie generierte Datenmenge steigt stetig, die Anforderungen an die Qualität der Daten werden sowohl von Seiten der Behörden als auch firmenintern immer höher, und die rasche Verfügbarkeit der Daten muss über Jahre hinweg – oft in nicht vorhergesehenen Zusammenhängen – garantiert sein. Dieses Seminar informiert Sie über die modernsten Trends und Möglichkeiten zur direkten elektronischen Erfassung und Handhabung von Daten und zeigt die regulatorisch korrekte Implementierung derartiger Systeme. Der Austausch mit anderen Teilnehmern erhöht das Spektrum an Informationen. Beispiele aus der Praxis und Videos von Live-Systemen reichern das Seminar an. Mehr hier

LABOTEC Suisse 2011 PALEXPO, Genève 08 – 09-Jun-2011, Booth D15 More here

Paperless Lab Forum 2011:
Basel, Thursday, 27-Oct-2011
The Paperless Lab Forum is the ideal opportunity to increase your knowledge and awareness of the Paperless Lab. Live demonstrations and Presentations of this forum provides the opportunity to get to know the vendors who are currently providing parts and pieces of a paperless lab process. More information and registration here

Partner News

Symyx Notebook by Accelrys v6.6: Integrating Pipeline Pilot, Isentris and Formulations!
Building on the exciting possibilities created by the merger of Accelrys and Symyx AND our new Enterprise R&D Architecture, Symyx Notebook by Accelrys v6.6 offers out-of-the-box integration with Accelrys’ Pipeline Pilot™ platform and improved connectivity with Accelrys Isentris® decision support software. The latest notebook release also provides new, productivity-enhancing capabilities for rapidly and efficiently moving chemical and biological formulations to scale-up production. More here

Trish Meek at Thermo Fisher Scientific and Dennis Fallen at Fisher BioServices look at creating a next-generation research information network to advance medicinal breakthroughs
Translational science is an emerging area of medical practice, integrating research inputs from the basic sciences, social sciences and political sciences to optimise patient care. This process, often described as ‘bench-to-bedside’, is at its core a relatively simple concept. By taking a focused point of view, the biomedical community is able to translate what it has learnt in the laboratory into the diagnosis and clinical treatment of patients. While this bench-to-bedside approach holds the promise of tomorrow’s innovative and personalized medical treatments, it presents some real challenges today. The sheer volume of data from these organisations poses an enormous obstacle, which is why informatics tools are an essential component of the translational science process, ensuring that all organizations are connected and have access to critical information, data and reports. More here

Integrated Science: Robert Pavlis at Labtronics
makes a case for the key types of lab automation products, stating that they are all useful for an efficient lab but an integrated, cohesive system is key for success. There are three key types of lab management products on the market today – LIMS, ELN and SDMS. Suppliers of each of these systems would have you believe that theirs is the most important system for your lab. Traditionally, laboratory information management systems (LIMS) have been the main lab management tool. Some electronic laboratory notebook (ELN) suppliers are now promoting their product as a LIMS replacement and similar claims have been made by scientific data management system (SDMS) developers. What is the correct role of each of these systems and which system do you really need? This article will address these two questions. More here

VelQuest Corporation, by John Helfrich Compliance Control – Procedure Execution Management System Reduces Compliance Risks by 10X.
The top drug GMP violations in 2009 involved failings in manufacturers' quality control units and failure to adhere to procedures and validation, with laboratory controls also having a top spot on the list. A common element of these top compliance issues is not following the written procedure/SOP at the “time of performance.” With respect to laboratory controls, several key complaints include “failures to follow test procedures and incomplete documentation in lab notebooks.” These key human resource failures can be expected to be even more an issue as drug manufacturers move production and materials sourcing from in-house and local processes to off shore and often remote locations in their globalization efforts. More here

Oracle: Product Lifecycle Management for the Pharmaceutical Industry
In recent years the pharmaceutical industry has faced declining R&D productivity, a rapidly changing healthcare landscape and fierce competition from generics resulting in lower growth and profit margins. Historically, drug development focused on clinical trials management and outcomes. Now however, the industry is looking at more holistic approaches to improve processes of bring new products to market that can accelerate product development while lowering operational costs. This is challenging because of the complex value chain and business processes required in this highly regulated environment. Additionally, it has proven difficult for the industry to effectively adapt as many pharmaceutical companies are simply not optimized for cross functional collaboration which is so desperately needed to support these changing market conditions. More here

Encountered

Thinking Beyond ELN - The Informatics Architecture Model.
Over the course of the last three years, Electronic Laboratory Notebook (ELN) products have expanded their core capabilities to include functionality not envisaged in the early days of the “paper replacement” ELN. With the introduction of LIMS-like features such as structured data management, request management, reporting, task workflow automation, and new application modules, ELN is offering benefits across a wide range of laboratory types. Commonly, the ELN is configured to the needs of departments to gain efficiencies at the laboratory bench. This domain-specificity offers the scientists a streamlined workflow to capture, annotate, and report data and information tailored to their individual requirements. More here

The Rules Governing Medicinal Products in the European Union Legal basis for publishing the detailed guidelines:
Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human use and Article 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use. More here

vialis AG • Kesselweg 40 • CH-4410 Liestal •
Tel: +41 61 813 01 78   • Fax: +41 61 813 01 79

Klicken Sie hier, falls Sie diesen Newsletter nicht weiter bekommen wollen.

Vialis News

Fachartikel in der GIT - Informatikstrategien für das Labor
Der Weg von Geschäftszielen zu messbaren Erfolgen Laborinformatik ist ein weites Feld. Es deckt die Domänen Forschung, Entwicklung und Dienstleistung bis hin zur Qualitätskontrolle ab. Gleichzeitig nutzt es typischerweise ein weites Spektrum an Applikationen verschiedenster Skalierbarkeit, von spezialisierten Einzelplatzlösungen über eine Vielzahl von Gerätesteuerungssoftware bis hin zu firmenweiten Systemen. Gemeinsam ist ihnen meist nur, dass sie auf unterschiedlichsten Plattformen laufen, auf unterschiedlicher Technologie basieren und von verschiedensten Herstellern geliefert und unterstützt werden. Mehr hier

Events

Wie mache ich mein Analytiklabor 21 CFR Part 11 tauglich?
Donnerstag, 16-Jun-2011
Der korrekte Umgang mit computergestützten Systemen in Analytik und Qualitätskontrolle ist in den letzten Jahren in immer stärkerem Maß in den Mittelpunkt gerückt. Das Seminar „Wie mache ich mein Analytiklabor 21 CFR Part 11 tauglich?“ dient dazu, sich über aktuelle regulatorische und technische Entwicklungen zu informieren und sich in Bezug auf Vorgehensweisen zur Erfüllung regulatorischer Anforderungen auf den neuesten Stand zu bringen. Der Austausch mit anderen Teilnehmern erhöht das Spektrum an Informationen und vergrößert die Möglichkeiten zur Umsetzung der Anforderungen. Beispiele aus der Praxis und Erfahrungsberichte mit Behörden reichern das Seminar an. Mehr hier

Laborprozesse Papierlos gestalten – Von der Idee bis zur Umsetzung:
Donnerstag, 01-Sep-2011
Die in analytischen und Qualitätskontrolllaboratorien der chemischen und pharmazeutischen Industrie generierte Datenmenge steigt stetig, die Anforderungen an die Qualität der Daten werden sowohl von Seiten der Behörden als auch firmenintern immer höher, und die rasche Verfügbarkeit der Daten muss über Jahre hinweg – oft in nicht vorhergesehenen Zusammenhängen – garantiert sein. Dieses Seminar informiert Sie über die modernsten Trends und Möglichkeiten zur direkten elektronischen Erfassung und Handhabung von Daten und zeigt die regulatorisch korrekte Implementierung derartiger Systeme. Der Austausch mit anderen Teilnehmern erhöht das Spektrum an Informationen. Beispiele aus der Praxis und Videos von Live-Systemen reichern das Seminar an. Mehr hier

LABOTEC Suisse 2011 PALEXPO, Genève 08 – 09-Jun-2011, Booth D15 More here

Paperless Lab Forum 2011:
Basel, Thursday, 27-Oct-2011
The Paperless Lab Forum is the ideal opportunity to increase your knowledge and awareness of the Paperless Lab. Live demonstrations and Presentations of this forum provides the opportunity to get to know the vendors who are currently providing parts and pieces of a paperless lab process. More information and registration here

Partner News

Labtronics’ LimsLink Connector for SAP provides seamless integration between SAP or SAP QM and any laboratory system. This connector supports a variety of workflows and uses a simple configuration environment to define the specific task required. In this Application Note we show how the LimsLink Connector for SAP supports an instrument driven workflow that reports test results directly to SAP and automatically backs up raw data and reports in an SDMS (Scientific Data Management System). More here

Serena - Orchestrated Demand Management
How to Use a Process-Based Approach to Efficiently Manage Demand Across the Application Lifecycle. More here

Thermo Scientific The electronics evolution – Connecting laboratory e-systems
The increased role of laboratory informatics in achieving strategic corporate objectives – such as decreasing product time to market and ensuring regulatory compliance – is an indicator of how integral the laboratory has become to the overall operations of the business. Since the introduction of Laboratory Information Management Systems (LIMS), laboratory staff has shifted their expertise from manual and time consuming activities to more sophisticated data analyses. More here

Encountered

EU GMP Annex 11 Revision I for comments: The Rules Governing Medicinal Products in the European Union, Volume 4
Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use Annex 11: Computerised Systems
Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human use and Article 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use. More here

IT Outsourcing and Offshoring: Recognizing and Managing Risk
By Arthur D. Perez, PhD and Glenn Morton
This article discusses risks and mitigation strategies that need to be considered between healthcare companies and outsourced IT suppliers. More here

vialis AG • Kesselweg 40 • CH-4410 Liestal •
Tel: +41 61 813 01 78   • Fax: +41 61 813 01 79

Klicken Sie hier, falls Sie diesen Newsletter nicht weiter bekommen wollen.

Vialis News

New Services from Vialis: The Multi Moment Analyss (MMA)
Many companies have found that business process optimization (BPO) and workflow redesign can deliver real benefits quickly. However, standard BPO rarely works for lab processes because of the variety, complexity and interdependency involved. In fact, classical BPO often results in poorly set targets, unspecific KPIs and unsound investment decisions. More here

Vialis at the LABOTEC in Geneva:
At LABOTEC Suisse 2011, the supply supply chain for laboratory equipment, analytical instruments and methods, laboratory information management systems, measurement and testing techniques, biotechnology and diagnostics will be represented. Visitors will gain a complete overview of the market with regard to state-of-the-art analytics and can structure their trade show visit to be even more efficient due to the thematic synergies.

LABOTEC Suisse 2011 is particularly aimed at decision-makers and specialist staff from laboratories who want to find out about the latest products, solutions and trends in these areas in an informal setting. The trade show quickly and simply provides professional visitors with a compact product overview and direct contact with the suppliers. More here

Events

LABOTEC Suisse PALEXPO, Genève 08-09-Jun-2011, Booth D15

Partner News

Case Study:
Paper free from Day One: ELN drives Collaborative Research at Kalexsyn
A perennial problem for organizations implementing electronic laboratory notebooks (ELNs) is convincing scientists to abandon paper notebooks. Kalexsyn, a contract research organization (CRO) based in Kalamazoo, MI, avoided this problem entirely by not leting its scientists develop paper-based routines in the first place. More here

Linking the Analytical Lab with Symyx Notebook Connecting the tools that power analytical research The “paperless lab” has provided scientists with techniques, software, and instrumentation that have increased the efficiency of individual workflows. Unfortunately, though, the exponential increase in electronic systems and software has failed to simplify data communication within the overarching framework of organizational R&D. Groups select the tools they need to work better— LIMS, chromatography data systems (CDS), document management systems, ELNs—but often fail to consider how they will share information across disciplines and effectively collaborate with colleagues across the hall or around the world. More here

Accelrys Releases Symyx Notebook 6.5 Supporting Process Chemistry
Accelrys, Inc. released Symyx Notebook 6.5 by Accelrys. This latest release of the multi-disciplinary Symyx electronic laboratory notebook (ELN) delivers improvements supporting chemical process development, production scale-up, and administrative compliance in pharmaceutical, fine chemicals, agrochemical, and consumer products markets. More here

Dionex Chromeleon CDS Interfaces to Nexxis ELN
Labtronics Inc., a world leader in laboratory automation is pleased to announce the release of a new interface connector between Chromeleon CDS from Dionex and Labtronics' Nexxis ELN.

This new interface connector links Chromeleon CDS and Nexxis ELN transparently, so that information is automatically exchanged between the two systems. Nexxis ELN can collect sample weights and all of the metadata for the sample prep process. The weights can then be sent to Chromeleon, allowing it to complete the concentration calculations. Results are then sent back to Nexxis ELN where they are automatically added to the same worksheet used for sample prep. More here

With a great pleasure Thermo Scientific announce the release of SampleManager 10.0.
This is the biggest release of SampleManager since version 1. This release meets a primary objective of moving SampleManager forward into a new technological arena. This delivers the platform to rapidly develop vertical solutions for the diverse markets SampleManager serves.
Thermo Scientific SampleManager LIMS 10 now available:
- Groundbreaking new functionality for laboratory personnel
- Comprehensive .NET tool kit for systems administrators and IT professionals
- More interactive and more visually oriented dashboard information for management
For more information, including technical information bulletins, videos and case studies, visit www.thermoscientific.com/samplemanager10

Improving enterprise-level productivity
In an environment of extreme cost containment, integrated informatics solutions contribute significantly to today’s pharmaceutical manufacturing laboratories that require increased product quality and compliance with strict regulations, as well as improved efficiencies that can lead to reduced costs. Modern LIMS (laboratory information management systems) serve as common platform frameworks that other informatics solutions, instrumentation, enterprise systems and enterprise communications tools can plug into to share common functions, without having to build them from scratch for each product. These systems are capable of storing data and methods in a safe and consistent way, thereby ensuring ultimate data security and integrity as well as effective processing distribution. More here

Encountered

Virtualization – Compliance and Control
This article presents the advantages and risks associated with the use of virtualization techniques in regulated areas and provide a list of quality focus issues to review, as a prerequisite to avoid the most likely pitfalls. More here

Change Management and ELN
Leading change is not easy, but understanding how to overcome the resistance barrier makes the process easier by Mike Elliot Atriumresearch More here 

vialis AG • Kesselweg 40 • CH-4410 Liestal •
Tel: +41 61 813 01 78   • Fax: +41 61 813 01 79

Klicken Sie hier, falls Sie diesen Newsletter nicht weiter bekommen wollen.

Vialis News

New Partnership: Vialis and Thermo Scientific announced global partnership. More here.

Visit us at ILMAC and get your free Ticket here.

Events

Paperless Lab Forum @ ILMAC 21-24 of September 2010.

An der ILMAC kommt dem Paperless Lab eine besondere Bedeutung zu. Ein Sonderpavillon ist das Kompetenzzentrum einer spezialisierten Industrie, die sich der Lösung von komplexen Problemen im Labordatenmanagement angenommen hat.
Das Paperless Lab Forum ist für die Besucher die ideale Plattform, an welcher man das Labor der Zukunft kennenlernen kann! Es ist eine Sonderausstellung, Forum und Begegnungszentrum in einem.
Das Paperless Lab Forum ist für Sie als Besucher die ideale Plattform, an welcher Sie Ihr Labor der Zukunft kennenlernen können! Es ist eine Sonderausstellung, Forum und Begegnungszentrum in einem:

• Auf einer kleinen und kompakten Ausstellerfläche sehen Sie hier die Komponenten welche es braucht, um ein Paperless Lab umzusetzen.
• Im Forum halten ausgesuchte Fachleute Vorträge zum Thema Paperless Lab und zeigen die Möglichkeiten die sich ergeben, Produkte die einen Beitrag leisten und geben Anleitung wie die Umsetzung erfolgen kann.
• Im Begegnungszentrum des Pavillons treffen sich Besucher, Aussteller und Referenten zum Fachgespräch, informieren sich über die Bedürfnisse ihrer Kundschaft und diskutieren Lösungsansätze.   

Wo sonst als an der ILMAC 2010 kann dem Paperless Lab eine ganz besondere Bedeutung zukommen? Das Paperless Lab Forum, Kompetenzzentrum der spezialisierten Industrie, empfängt Sie in der professionellen Atmosphäre einer kompetenten Fachmesse.
Kommen Sie an die ILMAC und besuchen Sie das Paperless Lab Forum. Mehr hier.

Partner News

Elan Combines Creativity and Isentris to Transform Research Information
Isentris is the center of the universe for our chemists,” explained Ajay Shah, director of research informatics at Elan. “They can do everything they want to do in the course of their day from a single interface.”
An Amalgamati on of Applications Like so many biopharmaceutical companies that carved out lucrative niches in the biotech boom of the late 1990s, Elan acquired informatics in a piecemeal manner over time as scientists sought ways to make their jobs easier. Elan chemists had built a chemistry database, Cbase, from the ground up in Oracle using a Java-based chemistry data cartridge. Biologists, on the other hand, had purchased a commercial biological activity data management system, but Elan had no system in place for general biology data management. More here.

Encountered

Guide for using Open Souce Software (OSS) in regulated industries based on GAMP. More here.


Thinking Beyond ELN - The Informatics Architecture Model Michael H Elliott;  CEO, Atrium Research & Consulting LLC
Over the course of the last three years, Electronic Laboratory Notebook (ELN) products have expanded their core capabilities to include functionality not envisaged in the early days of the “paper replacement” ELN. With the introduction of LIMS-like features such as structured data management, request management, reporting, task workflow automation, and new application modules, ELN is offering benefits across a wide range of laboratory types. Commonly, the ELN is configured to the needs of departments to gain efficiencies at the laboratory bench. This domain-specificity offers the scientists a streamlined workflow to capture, annotate, and report data and information tailored to their individual requirements. More here.


GMP Aktuell
FDA: Part 11 GMP Inspektionen im Fokus
Die FDA kündigte kürzlich an, dass sie zukünftig verstärkt das Thema Computervalidierung prüfen möchte. Die FDA möchte durch diese Aktion feststellen, wie die Anforderungen an das Thema "electronic records" durch die Industrie aktuell umgesetzt werden.

Grundlage der Inspektionen wird die Leitlinie "Part 11, Electronic Records; Electronic Signatures — Scope and Application" vom  August 2003 sein.

Was ist zu tun?
Es ist damit zu rechnen, dass die FDA bei den kommenden Inspektionen einen Blick auf die Validierung von computerisierten Systemen werfen wird. Bereiten Sie sich sorgfältig darauf vor und studieren Sie ggf. die bislang publizierten Warning Letters der FDA. Mit der  Durchführung der Inspektionen soll bald begonnen werden!

vialis AG • Kesselweg 40 • CH-4410 Liestal •
Tel: +41 61 813 01 78   • Fax: +41 61 813 01 79

Klicken Sie hier, falls Sie diesen Newsletter nicht weiter bekommen wollen.

Vialis News

Have a look at our Special Website and see the Paperless Lab in Action. Two Videos demonstrate how nice Life could be. More here 

Weiterbildung / Seminare / Veranstaltungen

Wie mache ich mein Analytiklabor 21 CFR Part 11 tauglich? 17. Juni 2010 Das Seminar erläutert die aktuellste regulatorische Sichtweise und Interpretation in Bezug auf computergestütze Systeme (u.a. 21 CFR Part 11, EU GMP Annex 11 Draft), erläutert die Vorgehensweise zur Implementierung von validierten Computersystemen – speziell auch in Bezug auf Neuerungen aus GAMP5 - und beschreibt unter anderem den Umgang mit 21 CFR Part 11 inkompatiblen Softwarelösungen aus praktischer Sicht. Die Aufrechterhaltung des validierten Zustands von Computersystemen und zugehöriges Change Management werden ebenfalls behandelt. Mehr hier

Paperless Lab Forum 2010 Innovation -> Product "A Paperless Lab Solution Makeover for the Personal Care Ingredients and Cosmetics Industries" 09. June 2010 The Paperless Lab Forum is the ideal opportunity to increase your knowledge and awareness of the Paperless Lab in the Personal Care Ingredients and Cosmetics Industries. Live demonstrations and Presentations at this forum provide the opportunity to get to know the vendors who are currently providing parts of the solution to a paperless lab process. More here

„Das papierlose Labor“ – Von der Idee bis zur Umsetzung 02. September 2010 Das Seminar gibt einen detaillierten Überblick über die modernsten Lösungen zur papierlosen Arbeitsweise in analytischen Laboratorien. Planung, technische Anforderungen und die Einführung regulatorisch kompatibler Lösungen basierend auf modernster LIMS-Technologie werden diskutiert und präsentiert. Dass es sich beim papierlosen Labor nicht um unerfüllte Träume handelt, wird anhand von Umsetzungsbeispielen aus der Praxis und einem Life-System demonstriert. Mehr hier

Partner News

Accelrys, Inc. and Symyx Technologies, Inc. Announce Merger Creates a New Leader in Scientific Informatics Software SAN DIEGO and SANTA CLARA, CALIF., April 05, 2010 – Accelrys, Inc. (NASDAQ: ACCL) and Symyx Technologies, Inc. (NASDAQ: SMMX) today announced that they have signed a merger agreement that will establish a new leader in scientific informatics software. More here

IMPLEMENTING AN ENTERPRISE ELN: LESSONS LEARNED AT LILLY Building on an initial process chemistry knowledge management tool first evaluated in 2003, Eli Lilly and company today is running a single platform electronic laboratory notebook (ELN) across its organization. Lill’s is used by more than 1’100 scientists and more than 600’000 experiments have been created within the system since its inception. More here

Lonza agrees to acquire MODA, a global leader in paperless quality control Basel, Switzerland, 12 May 2010 – Lonza Group Ltd announces that it has signed an agreement to acquire MODA Technology Partners (“MODA”), a software company that provides paperless quality control solutions. The acquisition will strengthen the Rapid Testing Solutions platform of Lonza’s Bioscience division by adding a complementary product offering for quality assurance (QA) and quality control (QC) organizations in the life-science industry. MODA’s technology platform offers automated data collection, ondemand analytics and workflow visualization of regulated manufacturing processes including environmental monitoring, utility testing, and product testing. The acquisition is expected to close during the second quarter of 2010. More here

Herausgepickt

Supporting workflows empowering R&D: An Informatics architecture model by Mike Elliot. More here


Informatics strategies for the convergent analytical lab In many labs today, the drive to replace paper has begun pitting two systems against each other. More here

vialis AG • Kesselweg 40 • CH-4410 Liestal •
Tel: +41 61 813 01 78   • Fax: +41 61 813 01 79

Klicken Sie hier, falls Sie diesen Newsletter nicht weiter bekommen wollen.

Vialis News

Die Vialis AG, ein weiterer Schritt auf der Erfolgsstrasse Mehr hier

Paperless Lab Forum goes Xing We started a new Forum in Xing. This platform helps to build a network around process optimization, products, technology implementation, and workflow optimization in a paperless lab environment. More here 

Weiterbildung / Seminare / Veranstaltungen

Visit us at Analytica B2.4.35www.analytica.de

Qualitätssicherung in analytischen Laboren 12-14 April 2010. Mehr hier

Papierlose Dokumentation im Pharma-Hygienemonitoring
Mittwoch 13-Mai-2009  heipha Dr. Müller GmbH, Eppelheim Mehr hier

Wie mache ich mein Analytiklabor 21 CFR Part 11 tauglich? 17. Juni 2010 Das Seminar erläutert die aktuellste regulatorische Sichtweise und Interpretation in Bezug auf computergestütze Systeme (u.a. 21 CFR Part 11, EU GMP Annex 11 Draft), erläutert die Vorgehensweise zur Implementierung von validierten Computersystemen – speziell auch in Bezug auf Neuerungen aus GAMP5 - und beschreibt unter anderem den Umgang mit 21 CFR Part 11 inkompatiblen Softwarelösungen aus praktischer Sicht. Die Aufrechterhaltung des validierten Zustands von Computersystemen und zugehöriges Change Management werden ebenfalls behandelt. Mehr hier

„Das papierlose Labor“ – Von der Idee bis zur Umsetzung 02. September 2010 Das Seminar gibt einen detaillierten Überblick über die modernsten Lösungen zur papierlosen Arbeitsweise in analytischen Laboratorien. Planung, technische Anforderungen und die Einführung regulatorisch kompatibler Lösungen basierend auf modernster LIMS-Technologie werden diskutiert und präsentiert. Dass es sich beim papierlosen Labor nicht um unerfüllte Träume handelt, wird anhand von Umsetzungsbeispielen aus der Praxis und einem Life-System demonstriert. Mehr hier

Partner News

U.S. Food and Drug Administration (FDA) Selects Quality Management System (QMS) Software Solution from MasterControl and i4DM SALT LAKE CITY – October 29, 2009 – MasterControl, a global provider of software solutions that enable regulated companies to improve internal efficiency and reduce overall costs while accelerating time to market, announced today that the company and i4DM, a MasterControl partner, have been selected as the software provider and implementation team of a quality management system (QMS) for the Food and Drug Administration (FDA). More here

Serena The Compliance Challenge Preparing for an audit is about as fun as a root canal. You have auditors spilling over evidence, asking for reports, and eating your donuts. Plus, ever-increasing regulatory requirements mean IT must continually add governance and control frameworks to the list of things to implement and manage. More here

Labtronics Nexxis ELN Now Includes an SDMS Labtronics Inc. announces that Nexxis SDMS, a web-based Scientific Data Management System, is now included as a fully integrated component of Nexxis ELN, their versatile, web-based Electronic Laboratory Notebook. More here

Labtronics LimsLink Now Includes SDMS for Automated Storage of Raw Data Labtronics Inc. announces that LimsLink, the industry's leading instrument/LIMS integration solution, now includes Nexxis SDMS, a web-based Scientific Data Management System that provides laboratories with secure central storage and retrieval of scientific data and documentation. More here

Herausgepickt

Applied Quality Risk Management Case Study – Laboratory Computerized Systems by Judy Samadelis and Winnie Capucci More here


Vialis offeriert Ihnen einen kostenlosen Vortrag zum Thema papierloses Labor, melden Sie sich dazu auf unserer Webseite an hier

vialis AG • Kesselweg 40 • CH-4410 Liestal •
Tel: +41 61 813 01 78   • Fax: +41 61 813 01 79

Klicken Sie hier, falls Sie diesen Newsletter nicht weiter bekommen wollen.

Vialis News

Forschung ohne Papier Beitrag aus CHEManager 18/2009 Mehr hier

Feedback from the Paperless Lab Forum09 Interview CHEManager 20/2009 Mehr hier

Paperless Lab Forum goes Xing

We started a new Forum in Xing. This platform helps to build a network around process optimization, products, technology implementation, and workflow optimization in a paperless lab environment. More here

Was man schon immer über ein LIMS Cockpit wissen sollte

sumIT hat in Kooperation mit Vialis ein Cockpit für das Labor Informations Management System (LIMS) entwickelt. Mit diesem Cockpit können Laborleiter

· den Betrieb des Labors überwachen

· die Vorgänge und Abläufe im Labor analysieren

· benchmarking zwischen Instrumenten, Materialien und Personen durchführen, sowie

· grafische Auswertungen von Messreihen erstellen (Beispiel: Annual Product Review).

Das Konzept des LIMS Cockpit wird in folgender Präsentation sowie in eine Demo vorgestellt. Mehr hier

Events

Visit us at Analytica B2.4.35 www.analytica.de

Method Validation & Transfer: Prediction of the Risks Linked to the Data Generated during the Life Cycle of Quantative Analytical Methods

Date:                        Thursday, 4th of February 2010 (09:00 - 17:00)

Place:                       Hotel Victoria, Centralbahnplatz 3-4, CH-4002 Basel

Target attendees:    This Seminar is aimed for managers and staff in the areas of analysis, quality control, development and quality assurance, which are entrusted with meeting regulatory requirements of method validation and transfer. More here

Partner News

Integration of Symyx Notebook and Thermo Scientific Watson LIMS accelerates Laboratory Workflows and Information Sharing

Collaboration Enables Time Savings and Regulatory Compliance, Helps Avoid Costly Errors SUNNYVALE, Calif., Oct. 27, 2009 – Symyx Technologies, Inc. (NASDAQ: SMMX) today announced an out-of-the-box integration of Symyx Notebook and Thermo Scientific Watson LIMS. The integration enables scientists engaged in biological and bioanalytical workflows to electronically pass study information, sample lists, experimental results and reports between the electronic laboratory notebook (ELN) and the LIMS, thereby reducing time-consuming manual transcription and data manipulation that can result in costly laboratory errors and regulatory compliance issues. More here

LimsLink and Nexxis SDMS - a Winning Combination for Managing Raw Data

Most laboratories already understand the value of storing their sample results in a secure central location - LIMS (laboratory information management system) - but what do they do with the raw data and reports that support those results? Where do they go to retrieve that raw data when it is needed for an investigation or an audit? More here

Release of ENOVAL V3.0Arlenda is proud to announce the release of E-Noval 3.0, the new version of analytical method validation software. More here

Encountered

Reducing Cost by Automating Laboratory Workflow

In laboratories the automation of operational procedures does not only concern practical analytical tasks but also documentation and control. The common keywords for extensive automation projects are: quality assurance, optimization and acceleration of procedures, reproducibility of results and the reduction of error ratios. Automation‘s intention is to provide the laboratory personnel with more time for its core tasks. From an economical point of view automation is a means of cost reduction. That economical and innovative criteria concerning laboratory techniques go well together shows a current project of automating operational procedures in a relevant laboratory. A medium-sized pharmaceutical company can expect millions of Euro cost reduction due to their intended automation project. More here

Journal of Chromatography B  Validation, comparison and transfer

This special issue of Journal of Chromatography B is devoted to validation, comparison and transfer of analytical methods. All the papers presented here, published following the regular procedure

of peer-review, are representative of the importance gain by methodological issues in biomedical, pharmaceutical, chemical, food and other important fields of analytical life sciences. More here

Vialis GmbH • Kesselweg 40 • CH-4410 Liestal •
Tel: +41 61 813 01 78 • Fax: +41 61 813 01 79

Vialis News

Die Registrierung für das Paperless Lab Forum09 ist eröffnet!

Das Paperless Lab Forum09 ist die ideale Plattform um Informationen zu sammeln, wie Automatisierung im Laborumfeld erfolgreich implementiert wird, wie Prozesse optimiert werden, wie die Produktivität sowie Effizienz gesteigert werden kann und gleichzeitig die Anforderungen an die Gesetzgebung einfacher erfüllt werden. Mehr hier

Rentschler Biotechnologie geht neue Wege im papierlosen Labordatenmanagement

Um das dynamische Wachstum der Rentschler Biotechnologie GmbH nachhaltig zu unterstützen und die Wettbewerbsfähigkeit weiter zu steigern hat sich die Rentschler Biotechnologie GmbH entschlossen, verschiedene Software Pakete einzuführen, mit dem Ziel Prozesse zu automatisieren und papierlos zu gestalten. Neben einem ERP System ist der papierlose QC-Prozess ein elementarer Bestandteil der angestrebten Prozessoptimierung bei gleichzeitiger Abdeckung aller regulatorischen Anforderungen. Als Basis dafür dienen das SQL*LIMS der Firma LabVantage Solutions, Inc. mit Zusatzmodulen und Geräteintegration und das Hygienemonitoring-Paket der Firma ModaTP. Zusätzlich wird eine Integration zum ERP-System realisiert wodurch eine durchgängige elektronische Prozessdokumentation erreicht wird. Die Firma Vialis zeichnet sich für die Umsetzung des Konzepts verantwortlich und begleitet die Rentschler Biotechnologie GmbH durch den gesamten Implementierungs- und Integrationsprozess. Mehr hier

Weiterbildung / Seminare / Veranstaltungen

„Das papierlose Labor“ – Von der Idee bis zur Umsetzung

Donnerstag, 03-Sep-2009 (09:30 – 17:00)  
Das Seminar gibt einen detaillierten Überblick über die modernsten Lösungen zur papierlosen Arbeitsweise in analytischen Laboratorien. Planung, technische Anforderungen und die Einführung regulatorisch kompatibler Lösungen basierend auf modernster LIMS-Technologie werden diskutiert und präsentiert. Dass es sich beim papierlosen Labor nicht um unerfüllte Träume handelt, wird anhand von Umsetzungsbeispielen aus der Praxis und einem Life-System demonstriert. Mehr hier

Partner News

LabVantage® Completes Acquisition of Life Technologies Corporation’s SQL*LIMS® Business
August 10, 2009. Bridgewater, New Jersey.

LabVantage today announced that it has completed the acquisition of Life Technologies Corporation’s SQL*LIMS business, uniting the premier thin-client LIMS with a significant global footprint of experienced LIMS professionals. Further, LabVantage highlighted that Pat Pijanowski, former General Manager of the SQL*LIMS business, has joined LabVantage as its Chief Operating Officer. More here

Embedded Interface Connects Agilent’s Cerity to any LIMS July 2009
Labtronics Inc., a world leader in laboratory data integration and management solutions is pleased to announce a LimsLink CDS Embedded Interface for Agilent’s Cerity that integrates Cerity with any LIMS, from right inside the Cerity client. More here

Labtronics Adds Laboratory Training Management to Nexxis iLAB August 2009
Labtronics Inc., a world leader in laboratory data integration and management solutions is pleased to announce the latest addition to Nexxis iLAB, the integrated laboratory solution where instruments, systems and people are able to automatically share and access information, as they need it. More here

The Enterprise Lab Notebook
Leverage the enterprise ELN to optimize the capture and reuse of information, protect intellectual property, streamline laboratory workflows, enhance partnerships, and accelerate the productivity of virtual teams. More here

Business Process Management. The Way It Was Always Meant To Be.
Ever wanted to put a business process online in a hurry? Want to make changes quickly? Want a great looking Web 2.0 interface to impress your business users? Want no more. With Serena you can develop in days rather than months, deploy in minutes and get a quick return on that precious IT investment. More here
 

Herausgepickt

Automatisierung von Arbeitsabläufen
Einsparpotentiale durch Laborautomatisierung in Pharmaunternehmen
In Laboren findet die Automatisierung von Arbeitsabläufen nicht nur auf der Ebene von praktisch-analytischen Tätigkeiten statt, sondern ebenso beim Aufwand für Dokumentation und Kontrolle. Die üblichen Stichworte der weitreichenden Automatisierungsüberlegungen lauten: Qualitätssicherung, Optimierung und Beschleunigung von Verfahrensabläufen, Reproduzierbarkeit der Ergebnisse und Reduktion der Fehlerraten. Es soll dadurch vorrangig Zeit für die tatsächlichen Kernaufgaben der Labormitarbeiter, seien es Synthese oder Analyse, geschaffen werden. Aus betriebswirtschaftlicher Sicht dient die Automatisierung der Kostenreduktion. Dass betriebswirtschaftliche Kriterien und labortechnische Innovation sich bestens ergänzen, zeigt ein aktuelles Projekt zur Automatisierung laborspezifischer Arbeitsabläufe, das Einsparpotentiale in Millionenhöhe für ein mittelständisches Pharmaunternehmen aufzeigte. Mehr Informationen

What You Should Know Before Selecting an ELN
Electronic laboratory notebooks have evolved into four distinct types of systems
Michael H. Elliott

In my last article on electronic laboratory notebooks (ELN), I noted that the technology had migrated from use only by visionary users to the broader market in just a few short years.1 I also stated that there are many different flavors of products available, from general-purpose systems to those focused on a particular application area. In this article, I will discuss the progression of systems from the late 1990s to today, describing four generations of ELN. Each of these generations is available on the market as a commercial product; the determination of which product is correct for your project is dependent on your organization’s ELN vision and strategy. More here

Vialis offeriert Ihnen einen kostenlosen Vortrag zum Thema papierloses Labor, melden Sie sich dazu auf unserer Webseite an.

Vialis GmbH • Kesselweg 40 • CH-4410 Liestal •
Tel: +41 61 813 01 78 • Fax: +41 61 813 01 79

Klicken Sie hier, falls Sie diesen Newsletter nicht weiter bekommen wollen.

Vialis News

Die Registrierung für das Paperless Lab Forum09 ist eröffnet!

Das Paperless Lab Forum09 ist die ideale Plattform um Informationen zu sammeln, wie Automatisierung im Laborumfeld erfolgreich implementiert wird, wie Prozesse optimiert werden, wie die Produktivität sowie Effizienz gesteigert werden kann und gleichzeitig die Anforderungen an die Gesetzgebung einfacher erfüllt werden. Mehr hier

Weiterbildung / Seminare / Veranstaltungen

Wie mache ich mein Analytiklabor 21 CFR Part 11 tauglich?

Donnerstag, 18-Jun-2009 (09:30 – 17:00)

Das Seminar erläutert die aktuellste regulatorische Sichtweise und Interpretation in Bezug auf computergestützte Systeme (u.a. 21 CFR Part 11, EU GMP Annex 11 Draft), erläutert die Vorgehensweise zur Implementierung von validierten Computersystemen – speziell auch in Bezug auf Neuerungen aus GAMP5 - und beschreibt unter anderem den Umgang mit 21 CFR Part 11 inkompatiblen Softwarelösungen aus praktischer Sicht. Die Aufrechterhaltung des validierten Zustands von Computersystemen und zugehöriges Change Management werden ebenfalls behandelt.

Es sind noch Plätze frei. Mehr hier

Improvement in QC Environmental Monitoring Processes with Paperless Data Capture System

Tuesday, June 2 | 11:00 - 11:45 AM (ET) Live, interactive presentation

Overview

To support the manufacture of this diverse array of products, Lonza Walkersville, Inc operates 13 clean room suites as well as a Horseshoe Crab (Limulus polyphemus) bleeding facility. The majority of these suites support Class 100/ISO 5 Aseptic Processing operations and require an extensive Environmental Monitoring (EM) program that generates large volumes of data. The concept of automating their EM program was the result of a company-wide Lean Six Sigma (LSS) initiative to eliminate waste, reduce lead and labor time, and mistake-proof processes. The EM program was identified as a target for LSS improvements because of numerous issues related to managing the program and the ever increasing volume of data. Following extensive evaluation, mobile and wireless technologies by MODA (a paperless solution) was chosen to automate Lonza's environmental monitoring and quality control SOPs. More here

„Das papierlose Labor“ – Von der Idee bis zur Umsetzung

Donnerstag, 03-Sep-2009 (09:30 – 17:00)  
Das Seminar gibt einen detaillierten Überblick über die modernsten Lösungen zur papierlosen Arbeitsweise in analytischen Laboratorien. Planung, technische Anforderungen und die Einführung regulatorisch kompatibler Lösungen basierend auf modernster LIMS-Technologie werden diskutiert und präsentiert. Dass es sich beim papierlosen Labor nicht um unerfüllte Träume handelt, wird anhand von Umsetzungsbeispielen aus der Praxis und einem Life-System demonstriert. Mehr hier

Partner News

Leveraging LIMS: SQL*LIMS Targets Simplicity and Speed

Applied Biosystems has made its already successful SQL*LIMS software easier and faster to deploy, and better integrated with companies’ extended software environments. SQL*LIMS business manager Pat Pijanowski takes us through what’s new with the software, and how it’s helping customers to cut costs, ease validation, and go paperless. More here

Symyx Notebook 6.2 Adds Synthetic Chemistry to Existing Analytical Chemistry Research and Biology Capabilities

Enterprise electronic lab notebook (ELN) provides new reaction chemistry capabilities and essential chemistry information in the context of laboratory workflows. More here

Symyx Announces Electronic Laboratory Notebook and LIMS Partnership with Thermo Fisher Scientific

Symyx enterprise lab notebook and decision support software adopted by industry-leading LIMS provider to improve information access and management.More here

ELN Reduces Regulatory Compliance Costs

It has been estimated that laboratories in a regulated environment dedicate up to 70% of their resources to compliancerelated functions.1 Clearly, these laboratories can achieve significant reductions in their compliance costs by reducing the amount of daily time and resources that are spent on maintaining regulatory compliance. More here

Herausgepickt

Domain Methodolgy for Computer Systems Specification and Varification
This article summarizes the domain methodology described in the GAMP Good Practice Guide on Manufacturing Execution Systems currently under development. More here

Vialis offeriert Ihnen einen kostenlosen Vortrag zum Thema papierloses Labor, melden Sie sich dazu auf unserer Webseite an.

Vialis GmbH • Kesselweg 40 • CH-4410 Liestal •
Tel: +41 61 813 01 78 • Fax: +41 61 813 01 79

Klicken Sie hier, falls Sie diesen Newsletter nicht weiter bekommen wollen.

Vialis News

One-Stop-Shop: Imagine a system that transfers data from your analytical equipment directly to your automatically generated CofA. No manual transcription, minimum review - no delay. Vialis interfaces any type of instrument to your LIMS.
Here some examples

Definition of a Paperless Laboratory:
The "Paperless Lab" is combination of different computer software that is used in the laboratory for the management of projects, batches/lots, samples, laboratory users, instruments, standards and other laboratory functions such as invoicing, contacts, and work flow automation.
More here
 

Weiterbildung / Seminare / Veranstaltungen

Dionex User Conference 26-May-2009 in Olten
Vortrag zum Thema Integration von Chromeleon und LIMS. Anmeldung hier

Wie mache ich mein Analytiklabor 21 CFR Part 11 tauglich? 18-Jun-2009 in Basel
Das Seminar erläutert die aktuellste regulatorische Sichtweise und Interpretation in Bezug auf computergestütze Systeme (u.a. 21 CFR Part 11, EU GMP Annex 11 Draft), erläutert die Vorgehensweise zur Implementierung von validierten Computersystemen – speziell auch in Bezug auf Neuerungen aus GAMP 5 - und beschreibt unter anderem den Umgang mit 21 CFR Part 11 inkompatiblen Softwarelösungen aus praktischer Sicht. Die Aufrechterhaltung des validierten Zustands von Computersystemen und zugehöriges Change Management werden ebenfalls behandelt. Mehr hier

Papierlose Dokumentation im Pharma-Hygienemonitoring
Mittwoch 13-Mai-2009  heipha Dr. Müller GmbH, Eppelheim Mehr hier

Partner News

The Real Costs of Paper in the Laboratory
A study that looked at the life cycle of paper in a typical office environment determined that a sheet of paper that cost .003 cents to purchase ends up costing the company 4.47 cents by the time it is finally disposed of. More here

Third Annual European Life Sciences Forum 2009
31-Mar and 01-Apr-2009
The European Life Sciences Forum 2009 is Oracle’s third annual dedicated conference for the life sciences community.. More here

Balance Interface Improves Productivity by 20%
A leading medical technology company with research centers around the world recognized a need to improve efficiency and eliminate errors with a manual weighing procedure that they were carrying out at one of their facilities. More here

Herausgepickt

GAMP5 Quality Risk Management Approach
This article describes how GAMP5 quality risk management strategy offers a pragmatic approach to computer systems compliance. Mehr hier.


Vialis offeriert Ihnen einen kostenlosen Vortrag zum Thema papierloses Labor, melden Sie sich dazu auf unserer Webseite an hier

Vialis GmbH • Kesselweg 40 • CH-4410 Liestal •
Tel:   +41 61 813 01 78   • Fax: +41 61 813 01 79

Klicken Sie hier, falls Sie diesen Newsletter nicht weiter bekommen wollen.

Vialis News

One-Stop-Shop: Please find out more about it at our new website More here.
 

Weiterbildung / Seminare / Veranstaltungen

Paperless Lab Forum 2008
Nach dem Riesen-Erfolg vom 13-Nov-2008 (über 120 Teilnehmer aus Pharma, Chemie und Biotech vom Laborleiter bis zum Geschäftsführer) steht das nächste Paperless Lab Forum vor der Tür. Reale Umsetzungsbeispiele welche seit dem Forum06/07/08 durch Besucher umgesetzt wurden sowie Informationsaustausch zum Thema papierloses Labor stehen im Vordergrund. Reservieren Sie jetzt schon das Datum in Ihrer Agenda. Anmeldungsdetails folgen Anfang 2009. Paperless Lab Forum09. Donnerstag, 29-Oct-2009 (09:00 – 17:00), Basel.

Partner News

Best practices in environmental monitoring automation
In the aseptic environment, an automated EM program ensures optimum control over potential Contamination , By Bob Toal, MODA Technology Partners

With increased demand for production of modern therapies using vaccines, injected drugs, and human tissue, there is an increase in the number of manufacturing facilities requiring aseptic processing conditions. In aseptic processing, where the end product cannot be terminally sterilized, it is especially critical that product is manufactured in an environment free of contaminants. And once the aseptic environment is established, it must be closely watched via comprehensive environment monitoring (EM) programs to ensure processing areas are under control for potential viable and non-viable contamination. More here.


Go Paperless in minutes – Are you ReDI™?
If your laboratory wants to go paperless, but you aren’t ready for another time consuming, resource intensive laboratory IT project - then you’re ready for ReDI, a new eForm deployment technology that eliminates the pain of long drawn out Electronic Laboratory Notebook implementation projects. More here.


Die 2D-Revolution
Von Dan Bodnar, Director, RFID and Data Capture Products, Intermec
In der Supply-Chain-Branche herrscht zunehmend die Meinung, dass der Ersatz von Barcodes durch RFID-Technologie näher rückt. Diese Annahme ist zwar nicht ganz unbegründet, doch die Realität sieht anders aus: Barcodes werden noch lange nicht abgeschafft, und die RFID-Implementierung wird trotz kontinuierlicher Fortschritte erst in ferner Zukunft den gesamten Alltag bestimmen. Gleichzeitig besteht in vielen Branchen ein Bedarf an Lösungen, die mehr als lineare Standard-Barcodes bieten. Daher gibt es eine Zwischenlösung in Form von 2D-Barcodes, die mehr Möglichkeiten als einfache lineare Barcodes bietet. More here.
 

Herausgepickt

Domain Methodolgy for Computer Systems Specification and Varification
This article summarizes the domain methodology described in the GAMP Good Practice Guide on Manufacturing Execution Systems currently under development.  Mehr hier.

GAMP5 Quality Risk Management Approach
This article describes how GAMP5 quality risk management strategy offers a pragmatic approach to computer systems compliance. Mehr hier.


Vialis offeriert Ihnen einen kostenlosen Vortrag zum Thema papierloses Labor, melden Sie sich dazu auf unserer Webseite an

Vialis GmbH • Kesselweg 40 • CH-4410 Liestal •
Tel:  +41 6... • Fax: +41 61 813 01 79

Vialis News

One-Stop-Shop: Schauen Sie vorbei und erfahren mehr über unsere neue Website. Mehr hier.

Transval is a software dedicated to the confirmation that an analytical method could be transferred based on Total Error concept.
An analytical transfer is a complete process that consists in transferring a validated analytical method from a sending laboratory (called sender) to a receiving laboratory (called receiver) after having experimentally demonstrated that it also masters the method. The experiments performed in such a transfer and the methodology used to accept or reject it should be fitted for purpose. It is highly critical to have all the guarantees that the method is mastered by the receiver in order to avoid problems in the future. More here.
 

Weiterbildung / Seminare / Veranstaltungen

Paperless Lab Forum 2008
Nach dem Riesen-Erfolg von 2006 (über 100 Teilnehmer aus Pharma, Chemie und Biotech vom Laborleiter bis zum Geschäftsführer) sowie der erfolgreichen Integration des Paperless Lab Forum in der ILMAC07 steht das nächste Paperless Lab Forum vor der Tür. Reale Umsetzungsbeispiele welche seit dem Forum06 durch Besucher umgesetzt wurden sowie Informationsaustausch zum Thema papierloses Labor stehen im Vordergrund. Neben Vorträgen (unter anderem von Michael H. Elliott, dem Gründer von Atrium Research und Christian Reck von der F. Hoffman-La Roche AG) und live-Demonstrationen bietet eine kleine Ausstellung die Möglichkeit, sich aus erster Hand bei verschiedenen Herstellern über Komponenten des papierlosen Labors zu informieren und Networking zu betreiben. Da die Anzahl Plätze auf 100 beschränkt ist melden Sie sich jetzt an und sichern Sie sich einen Platz am Paperless Lab Forum08. Donnerstag, 13-Nov-2008 (09:00 – 17:00), Basel.  Mehr hier

Partner News

The Gap Between LIMS Capabilities and Environmental Monitoring Needs
While laboratory tests are an important part of Environmental Monitoring (EM) operations, the EM workflow is complex and the EM workplace presents a unique set of challenges.  Commercial Off-The-Shelf (COTS) LIMS products bring a wide range of functions to help automate the analytical laboratory, but struggle to meet the unique challenges of the
EM operation.
This paper reviews the workflow typically found in EM operations to identify the needs of the EM organization. It matches the capabilities of commercial LIMS to these needs, and discusses the LIMS customizations that would be required to close these gaps. It also discusses two
alternative approaches to building an interface between an EM-specific product, such as MODA-EM, and a commercial LIMS. More here.

CDS/LIMS Interface Saves 9’000 Man Hours Per Year
This interface was developed for a major international pharmaceutical company whose manual processes for managing large volumes of data from their Empower CDS were both time consuming and costly for the lab. They were manually creating their Sample Sets for Empower using worklists from LIMS and then after the samples were analyzed they were manually entering all of the Empower result data into LIMS. After the data was entered into LIMS, it had to be manually reviewed for errors. This slowed down the transfer of results into LIMS, creating delays for end users who needed to work with the sample results. Because it was a manual system there was always the risk of incorrect data slipping through the system, even with the additional time they were spending on review. More here.


New Symyx Notebook Supports Multiple Scientific Disciplines and Enhances Scientists’ Freedom to Experiment – Streamlining Operations, Enhancing Collaboration, Lowering Costs and Accelerating Productivity for R&D
Santa Clara, Calif., April 28, 2008 – Symyx Technologies, Inc. (Nasdaq: SMMX) today announced availability of Symyx Notebook—a new, enterprise electronic laboratory notebook (ELN) that is configurable to meet the needs of biologists and analytical chemists out-of-the-box. Symyx Notebook simplifies laboratory operations and lowers costs by enabling R&D organizations to replace multiple discipline-specific ELNs with a single, multi-discipline application that is deployable across the enterprise. Symyx Notebook gives project teams the freedom to experiment with confidence in a collaborative research environment. More here.

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Zum Thema Projektmanagement
Projektmanagementweisheiten. Mehr hier.


Vialis offeriert Ihnen einen kostenlosen Vortrag zum Thema papierloses Labor, melden Sie sich dazu auf unserer Webseite an

Vialis GmbH • Kesselweg 40 • CH-4410 Liestal •
Tel: +41 61 813 01 78 • Fax: +41 61 813 01 79

Vialis News

Seit dem 1-April 2008 hat die Vialis einen neuen Webauftritt. Ein wichtiger Schritt ist die Anpassung der Mission und Vision aufgrund des geänderten Fokus von LIMS Implementierung hin zu Gesamt-Konzept- und Lösungs-Anbieter.
One-Stop-Shop: Schauen Sie vorbei und erfahren mehr über unsere neue Website und Ausrichtung.

Neue Partnerschaft im Bereich Projektmanagement für das Labor
Serena Software und Vialis Paperless Lab Solutions erleichtern Pharma-Unternehmen die Arbeit: Beide Firmen kombinieren ihre Best-in-Class Lösungen und bringen Labor- und  Projektmanagement-Anwendungen, die die strengen Vorschriften der Pharma-Branche erfüllen. Die Projekt-Portfolio-Management (PPM)-Software Serena Mariner optimiert die anfallenden Prozesse mit vordefinierten Workflows, Finanzanalysefunktionalität oder Echtzeit-Reporting. Darüber hinaus lassen sich mit Serena Mariner die Ressourcen bestens planen und somit Kosten sparen. In Kombination mit Vialis‘ Applikationen und Services erhalten Pharma-Unternehmen eine transparente Projekt-Realisierung: Vordefinierte Lösungs-Templates und kostenlose Maturity-Assessments garantieren den schnellen Einsatz ebenso wie Schulungen und Quick-Start-Serviceangebote.
Mehr hier

Wir haben unser Team im Bereich Consultant erweitert.
Sven Lammers ist Deutscher und hat an der Universität Heidelberg und Kapstadt Physik studiert und an der Universität Basel in Theoretischer Chemie promoviert. Sven arbeite an verschieden Forschungsinstituten und besitzt ausgezeichnete Programmierkenntnisse durch seine wissenschaftlichen Softwareentwicklungen. Er entwickelte bei Symyx Technologies Software zur Datenbankabfrage, Visualisierung und Berichterstellung von wissenschaftlichen Daten. Er verfügt über weitreichende Kenntnisse im Einsatz von Software zur Steuerung und Organisation komplexer Arbeitsabläufe in der chemischen und pharmazeutischen Industrie.
Katherine Golubowski ist britisch und hat an der Universität Heidelberg Medizinische Informatik studiert. Katherine arbeitete für Ciba Geigy (heute Novartis), Hoffmann-La Roche und Unilog im Bereich AppliKations-Entwicklung, wo sie für Programmentwicklung für Oracle Datenbanken, Cheminformatics und LIMS Systeme verantwortlich war. Sie verfügt über umfassende Erfahrung in AppliKations-Entwicklung, Datenmanagement und Systemvalidierung.
Das gesamte Vialis Team hier

Weiterbildung / Seminare / Veranstaltungen

Wie mache ich mein Analytiklabor 21 CFR Part 11 tauglich?
Das Seminar erläutert die aktuellste regulatorische Sichtweise und Interpretation in Bezug auf computergestütze Systeme (u.a. 21 CFR Part 11), ebenso die Vorgehensweise zur Implementierung von validierten Computersystemen und beschreibt unter anderem den Umgang mit 21 CFR Part 11 unkompatiblen Softwarelösungen aus praktischer Sicht.
Donnerstag, 03-Jul-2008 (09:30 – 17:00)
Mehr hier

Paperless Lab Forum 2008
Das Paperless Lab Forum 2008 bietet die ideale Gelegenheit, sich zum Thema papierloses Labor zu informieren. Neben Vorträgen (unter anderem von Michael H. Elliott, dem Gründer von Atrium Research) und live Demonstrationen bietet eine kleine Ausstellung die Möglichkeit, sich aus erster Hand bei verschiedenen Herstellern über Komponenten des papierlosen Labors zu informieren und Networking zu betreiben.
Donnerstag, 13-Nov-2008 (09:00 – 17:00), Basel
Mehr hier

Partner News

MODA Technology Partners and Applied Biosystems team with XOMA for deployment of SQL*LIMS Micro/EM™ at Berkeley, CA Manufacturing Facilities
WAYNE, Pa.--(BUSINESS WIRE)--MODA Technology Partners (MODA), a software company that provides mobile data acquisition solutions to the pharmaceutical manufacturing industry, today announced that XOMA Ltd. (XOMA), has deployed SQL*LIMS Micro/EM™ to automate environmental and utility monitoring and processes at their biologics manufacturing facilities in Berkeley, CA
Mehr hier

LimsLink Reduces Data Entry Time by 90%
This application note demonstrates how the flexibility of LimsLink and the resourcefulness of our Labtronics’ Professional Services group eliminated 2 data
management bottle necks and reduced the time for getting results into LIMS from 45 minutes per sample to 5 minutes per sample.
Mehr hier

Serena Mariner eine Applikation für das Labor Projekt und Portfolio Management
Wir freuen uns sehr, Mariner for Labs als erste Projekt Management-Lösung von Serena für das Laborumfeld vorstellen zu können. Die Lösungen von Serena werden heute schon bei mehr als 15’000 Firmen eingesetzt. Dank Mariner können Unternehmen die Entwicklungsprozesse automatisieren und ihre IT-Architektur und Projekte effizient verwalten. Durch das Know How der Vialis Paperless Lab Solutions wird diese Funktionalität jetzt direkt in Ihre Laborumgebung integriert, wie z.B. mit LIMS oder ELN-Systemen.
Mehr hier

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The Rules have Changed
The management of electronic research records is more important than ever before by Mike Elliot Atrium Research published in Scientific Computing
A patent provides rights to an inventor to restrict the ability of others to make, use, or sell an invention. To obtain a patent, an inventor must submit a novel and unique concept to a government agency. In the scientific domains, laboratory notebooks are typically used as the primary evidence to prove inventorship of a concept and the details of its first successful use or what is known as "reduction to practice".
Mehr hier

Vialis offeriert Ihnen einen kostenlosen Vortrag zum Thema papierloses Labor, melden Sie sich dazu auf unserer Webseite an

Vialis GmbH • Kesselweg 40 • CH-4410 Liestal •
Tel: +41 61 813 01 78 • Fax: +41 61 813 01 79

...and Vialis GmbH, a leading systems integrator for laboratory data systems today formally announced a partnering agreement.
Mehr hier

Weiterbildung / Seminare / Veranstaltungen

Wie mache ich mein Analytiklabor 21 CFR Part 11 tauglich?
Das Seminar erläutert die aktuellste regulatorische Sichtweise und Interpretation in Bezug auf computergestütze Systeme (u.a. 21 CFR Part 11), erläutert die Vorgehensweise zur Implementierung von validierten Computersystemen und beschreibt unter anderem den Umgang mit 21 CFR Part 11 unkompatiblen Softwarelösungen aus praktischer Sicht.
Donnerstag, 03-Jul-2008 (09:30 – 17:00)
Mehr hier

Paperless Lab Forum 2008
Das Paperless Lab Forum 2008 bietet die ideale Gelegenheit, sich zum Thema papierloses Labor zu informieren. Neben Vorträgen (unter anderem von Michael H. Elliott, dem Gründer von Atrium Research) und live Demonstrationen bietet eine kleine Ausstellung die Möglichkeit, sich aus erster Hand bei verschiedenen Herstellern über Komponenten des papierlosen Labors zu informieren und Networking zu betreiben.
Donnerstag, 13-Nov-2008 (09:00 – 17:00), Basel
Mehr hier

Pharma Tage® Paperless Lab® Dynamics CRM
16-Apr-2008
-    13:00 Uhr bis 18:00 Uhr
-    Microsoft Schweiz, Richtistr. 3, 8304 Wallisellen, Schweiz
17-Apr-2008
-    13:00 Uhr bis 18:00 Uhr
-    Microsoft Deutschland, Konrad-Zuse-Str. 1, 85716 Unterschleissheim
18-Apr-2008
-    13:00 Uhr bis 18:00 Uhr
-    Microsoft Deutschland GmbH, Stresemannallee 4(b), 41460 Neuss
Mehr hier

Symyx invites you to join us for the 2008 Symyx Global Symposium,
slated for May 18-20 in Prague, Czech Republic. Symyx is proud to announce that 2008 is the first year that we bring the global user meeting to Europe, and we hope you’ll join us to hear presentations on best practices from pharmaceutical, chemical and biotechnology companies, a scientific poster session as well as interactive panels, workshops, and training sessions.
Mehr hier

Partner News

Paperless Environmental Monitoring
SQL*LIMS® Micro/EM solution that improves the performance of Environmental Monitoring (EM) operations The Life Sciences industry is challenged to improve product quality, increase productivity, and ensure regulatory compliance while reducing overall operating costs. In today's environment, most manufacturing and laboratory operations rely heavily on manual, paper-based processes that are inefficient and error prone. Transcription errors, failure to take appropriate actions, or taking incorrect actions can impact a company's ability to comply with agency regulations...
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New! SQL*LIMS QEMS - Quality Management for all Deviation tracking, OOS, CAPA investigations, analysis and quality improvement programs. The solution provides the user with an easy to use web based application to initiate, manage and analyze quality events including goal based quality improvement initiatives. The program integrates directly into the SQL*LIMS product suite. SQL*LIMS QEMS provides a simplified single data collection point for managing quality for a single laboratory or multiple laboratories including multipe sites. Mehr hier

Applied Biosystems and METTLER TOLEDO Introduce Solution to Simplify the Flow of Information in Life Science and Chemistry Laboratories
FOSTER CITY, Calif. and GREIFENSEE, Switzerland –December 17, 2007 – Applied Biosystems (NYSE:ABI), an Applera Corporation business, and METTLER TOLEDO (NYSE: MTD), today announced an integrated solution that is expected to improve the workflow and the transfer of information in laboratories for many scientific disciplines, including the life science, chemistry, food and petrochemical industries. The companies have collaborated to create a unique solution through which they are providing researchers in these fields the means to exchange data between precision instruments and laboratory information management systems.
Mehr hier

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Laboratory Informatics for Pharmaceutical and Biotech Research SQL*LIMS® Raises the Bar for LIMS
Without the need for extensive customization or compromising end-user satisfaction, we have integrated lot/batch management, stability testing, environmental monitoring (EM), quality event management, and the electronic notebook into SQL*LIMS. As a single-source data repository, SQL*LIMS seamlessly incorporates these disparate pools of data that are typically manually processed or stored in separate systems across QA/QC functions. The SQL*LIMS product family is the only solution available today that integrates a full set of data required by the QA/QC organization.
Mehr hier

Commissioning and Qualification: A New ASTM Standard – GMP Regulations
This article clarifies the principles and practices in the new ASTM Standard and presents how a new standard will impact the ISPE C&Obaseline Guide Revision.
Mehr hier

Vialis offeriert Ihnen einen kostenlosen Vortrag zum Thema papierloses Labor, melden Sie sich dazu auf unserer Webseite an

Vialis GmbH • Kesselweg 40 • CH-4410 Liestal •
Tel: +41 61 813 01 78 • Fax: +41 61 813 01 79

Vialis News

Das Paperless Lab an der ILMAC ein Riesenerfolg
Impressionen vom Sonderpavillion Paperless Lab Solutions an der ILMAC 2007. Bilder finden Sie hier.
VIALIS macht aus Ihrer Not eine Tugend – das papierlose Labor, ein Interview mit Ulf Fuchslueger hier.
Fachartikel „Realisierung eines Paperless Lab-Projekts“ hier

SumIT & Vialis lancieren das SQL*LIMS Cockpit
Das SQL*LIMS Cockpit basiert auf Oracle Business Intelligence Tools und ist ein System welches laufend Labordaten in elektronischer Form zur systematischen Analyse (Sammlung, Auswertung, Darstellung) zur Verfügung stellt. Ziel ist die Gewinnung von Erkenntnissen, die in Hinsicht auf die Unternehmensziele bessere operative oder strategische Entscheidungen ermöglichen. Dies geschieht mit Hilfe analytischer Konzepte, die Daten über Status der Proben, Methoden, Resultate und User und Geräte liefert. Mit den gewonnenen Erkenntnissen können Unternehmen ihre Laborprozesse, Auslastung der Geräte und Personal optimieren, Kosten senken, Risiken minimieren und die Wertschöpfung vergrößern.

Weiterbildung / Seminare / Veranstaltungen

Die Eidgenössische Alkoholverwaltung (EAV) und die Vialis GmbH laden Sie zum Tag der offenen Tür und zum Kick-off des Papierlosen Labors der EAV herzlichst ein.
Anhand von Vorträgen und Demos wird die Planung und Umsetzung des Projekts bei der EAV aufgezeigt.
Am anschliessenden Apéro, gesponsert von der Firma Vialis GmbH, haben Sie die Gelegenheit mit dem Projektteam und den Nutzern zu diskutieren und Erfahrungen auszutauschen.

Partner News

Getting More Out of your LIMS
Real-Time Management of OOS (Out-of-Specification) Test Results. In this article, we are going to show how test specifications that are stored in LIMS can be used to alert analysts to potential problems as they are running their tests, reducing the amount of time and effort that is spent on identifying OOS (out-of-specification) sample results and taking appropriate remedial action.

New Laboratory Information Management Solution From Applied
Biosystems Brings Efficiency and Cost Effectiveness to Drug
Development and Manufacturing Process
Pre-configured and Validated Solution Reduces the Cost and Time Associated With Implementation .
The SQL*LIMS® Plug and Play Pharma Package(TM) solution is a pre-configured and validated LIMS developed specifically for the pharmaceutical industry that has been shown to reduce up-to 85% of the cost and as much as 75% of the time associated with deployment(1).

Herausgepickt

Neue Broschüre erleichtert Umgang mit REACH
Seit etwa einem Jahr arbeitet die Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA) als nationale Auskunftsstelle (Helpdesk) für das neue europaweit geltende Chemikalienrecht.

Vialis News

Vialis distributes Atrium Research market research publications, amongst others the ground breaking report Electronic Laboratory Notebooks: A Foundation for Scientific Knowledge Management.

Weiterbildung / Seminare / Veranstaltungen

„Das papierlose Labor“ – kein Traum sondern Wirklichkeit Donnerstag, 18-Oct-2007 (09:30 – 17:00)
Der korrekte Umgang mit computergestützten Systemen in Analytik und Qualitätskontrolle ist in den letzten Jahren in immer stärkerem Maß in den Mittelpunkt gerückt. Das Seminar „Wie mache ich mein Analytiklabor 21 CFR Part 11 tauglich?“ dient dazu, sich über aktuelle regulatorische und technische Entwicklungen zu informieren und sich in Bezug auf Vorgehensweisen zur Erfüllung regulatorischer Anforderungen auf den neuesten Stand zu bringen. Der Austausch mit anderen Teilnehmern erhöht das Spektrum an Informationen und vergrößert die Möglichkeiten zur Umsetzung der Anforderungen. Beispiele aus der Praxis und Erfahrungsberichte mit Behörden reichern das Seminar an.

Paperless Lab Solutions an der ILMAC 25 – 28 September 2007
Sehen Sie Ihren Arbeitsplatz der Zukunft. Im Paperless Lab Solutions Pavillon an der ILMAC können Sie sich von der Planung über die verschiedene Produkte bis zur Implementierung eines Papierlosen Labors informieren.
Besorgen Sie sich Ihren gratis ILMAC Zutritt hier: www.paperlesslab.ch .

Partner News

Atrium Research and Vialis Announce Partnership
Wilton, Connecticut USA (June 12, 2007) - Atrium Research, the only market research organization dedicated to scientific informatics, and Vialis GmbH, a leading informatics consulting firm, announced today a strategic alliance. Under this new agreement, Vialis will distribute Atrium Research market research publications, starting with the ground breaking report Electronic Laboratory Notebooks: A Foundation for Scientific Knowledge Management. This agreement is a first step toward a broader alliance between the two companies to meet the growing need for scientific informatics strategy, process optimization, vendor selection, and integration services.

Additional Automation Increases the Value of LIMS Interfacing
Laboratories that use basic instrument/LIMS interfaces to simply transfer data from their instruments to their LIMS, are missing out on an opportunity to further reduce their costs and increase their efficiency and productivity.

SQL*LIMS P4 - Plug & Play Pharma Package - (SQL*LIMS)
ABI is introducing their new SQL*LIMS® Plug & Play Pharma Package – SQL*LIMS P4 - a fully configured and validated system design that incorporates the industry Best Practices and gets you up and running in as little as two months. The SQL*LIMS® Plug & Play Pharma Package is perfect for labs looking for rapid deployment of a fully functional, fully validated LIMS solution.

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Managing Risk Achieving FDA Complaince Using ISO 14971
A current popular aphorism in the FDA regulated pharmaceutical and biotech arenas are the words, “risk management.” They are being used by regulated pharmaceutical and biotech manufacturers worldwide, as well as by standards
developers and regulatory agencies whose primary focus is on the safety and efficacy of regulated products. Although, perhaps ‘risk management’ is a new term for the drug makers as opposed to the medical device makers, if you are, indeed, from the device side of the regulated business, the term stems from the ever- growing need to provide safer and more effective devices to the marketplace.

Vialis News

Wir haben unser Team erweitert. Seit dem 01-Apr-2007 ist Elke Schneider Locher als Senior Consultant an Board. Elke Schneider Locher ist Deutsche und hat an der Universität von Konstanz Biologie studiert. Nach einer Zusatzausbildung in Informatik hat sie bei Softlab als Softwareentwickler gearbeitet. Als Applikations Manager für ein Sample Management System bei Hoffmann-La Roche lernte sie das Pharmageschäft kennen. Bei Elsevier MDL unterstützte sie Kunden in der Verwaltung wissenschaftlicher Daten und leitete das Technische Support Team in Europa. Sie verfügt über umfassende Erfahrung in den Bereichen Datenverwaltung, Prozessanalyse, Projektmanagement, Schulung, Softwarevalidierung und Technischem Support.

Das Paperless Lab Forum goes ILMAC.
Wir haben ein Team von Firmen unter dem Dach “Paperless Lab Solutions“ in einem speziellen Themen Pavillon mit integrierten Forum zusammen gebracht. Vorträge sowie Aussteller finden Sie hier www.paperlesslab.ch .

Weiterbildung / Seminare / Veranstaltungen

Wie mache ich mein Analytiklabor 21 CFR Part 11 tauglich?
Der korrekte Umgang mit computergestützten Systemen in Analytik und Qualitätskontrolle ist in den letzten Jahren in immer stärkerem Maß in den Mittelpunkt gerückt. Das dient dazu, sich über aktuelle regulatorische und technische Entwicklungen zu informieren und sich in Bezug auf Vorgehensweisen zur Erfüllung regulatorischer Anforderungen auf den neuesten Stand zu bringen. Mehr hier

Paperless QM in Betrieb und Labor – Dokumentieren und Kommunizieren leicht gemacht. 14. Juni 2007, 9:00 - 16:30 Uhr mehr hier

Dionex Chromeleon User Meeting 12 Juni 2007
Profitieren Sie von diesem Angebot und melden Sie sich heute noch an!
Die Teilnehmerzahl ist beschränkt und kostenlos. Mehr hier

Partner News

Waters Corporation And Symyx Technologies, Inc. To Collaborate
BioResearch Online (press release) - Horsham,PA,USA
The combination of Symyx’s Electronic Lab Notebook and Waters’ NuGenesis SDMS will help provide our customers a competitive advantage in the market.”
See all stories on this topic

Applied Biosystems Releases New Versions of SQL*LIMS® Software and Adds New Functionality
February 25, 2007. Foster City, CA. Applied Biosystems announced new versions and enhancements of its award-winning SQL*LIMS Software at this year’s Pittcon 2007 Conference & Expo. The company released a new 5.1 version of the software that supports Oracle 10gR2 Database, introduced SQL*LIMS® P4™―a true Plug & Play LIMS for pharmaceutical QA/QC, and announced the development of advanced analytics for its SQL*Stability Software.

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Ein runder Tisch für eHealth in Spitälern
Unter dem Dach von Oracle versammelt sich unter der Überschrift
Synthesised Health eine kleine aber illustre Runde, um die Spitäler in der Schweiz, was eHealth betrifft, weiter voranzubringen. Mehr hier

Vialis News

Wir haben unser Team erweitert. Seid dem 01-Jan-2007 ist Norbert Liebisch als Consultant für die Vialis GmbH tätig. Norbert Liebisch ist Österreicher und hat an der Ludwig-Maximilians-Universität München  Informatik studiert. Norbert hat während seines Studiums als Gründungsmitglied das networkerz project team mitaufgebaut und zahlreiche CMS und Web-Applikationen dafür entwickelt. Zusätzlich arbeitete er parallel als freier Softwareentwickler. Er verfügt über umfassende Erfahrung in den Bereichen Datenbanken, Software-Engineering und Markupsprachen.

Am 15-Mar-2007 findet das “Validation of Analytical Methods using Advanced Statistics and Automated Reporting” Seminar in Basel statt. Es sind noch wenige Plätze frei.

Partner News

Santa Clara, Calif. – January 10, 2007 – Symyx Technologies, Inc. (Nasdaq: SMMX) today announced the release of Symyx Software Discovery Notebook version 4.0. The Discovery Notebook is one of a series of Symyx Software offerings which include electronic lab notebook (ELN) applications tailored to meet the specific needs and protocols of chemists in the discovery, process, analytical, formulations and bioprocess functions. The latest version of Discovery Notebook features an easy-to-use interface for single and parallel experimentation.

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GAMP 4 Überarbeitung
Das GAMP Council plant die Überarbeitung von GAMP 4. GAMP 5 wird berücksichtigen, dass der Trend in der pharmazeutischen Industrie immer stärker zur Nutzung von kommerziellen Softwarelösungen und weg von spezifischen Entwicklungen läuft. Der Fokus wird dabei auf kosteneffektiver Validierung unter Berücksichtigung des Risikoaspekts liegen und auch auf neue Regelwerke wie ICH Q9 und Q10, die FDA-Initiative „cGMPs for the 21st century“, die PIC/S Guidance und Empfehlungen des ASTM E55 Komitees Rücksicht nehmen. Mehr dazu erfahren Sie in weiteren Ausgaben des Newsletters.

An ELN by any other name
The market for electronic lab notebooks is growing apace, but opinions differ as to what this software actually does. Tom Wilkie and David Robson sampled some views (Scientific Computing World: December 2006/January 200/). Electronic laboratory notebooks (ELNs) represent one of the fastest-growing informatics markets, with a growth rate of more than 30 per cent a year, and double-digit growth will continue over the next four years, according to a recent survey from Atrium Research. 

Das „papierlose Labor“ – schneller, genauer, ökonomisch!
Dass elektronisch verfügbare Daten gegenüber Daten in Papierform zahlreiche Vorteile aufweisen, ist hinlänglich bekannt. Nur elektronische Daten erlauben die heute notwendige rasche Generierung und Verteilung von Information und somit die oft wettbewerbsentscheidende Umsetzung dieser Information zu Wissen.

Vialis News

Über 100 Teilnehmer am Paperless Lab Forum06 in Basel. Mehr dazu hier.

Anbei einen Link zu einigen Impressionen dieses Anlasses. Zu den Bildern: http://www.vialis.ch/de/seminare/seminar_061027_bilder.php

Partner News

SQL*LIMS Software Enables Astra/Zeneca to Reduce Data Review and Operate a Seamlessly Integrated Paperless Laboratory.

High Resolution Imaging und Analyse. Wie neue Technologien die Möglichkeiten der digitalen Bildverarbeitung revolutionieren und neue Wege in der Forschung eröffnen.

Analytics mit Spotfire-unterstützer Intuition. Daten unterschiedlichster Quellen zusammenführen und Ergebnisse visualisieren – mit der graphischen Aufbereitung von Versuchsreihen kommen Wissenschaftler ihrem Ziel rasch näher. Besonders dann, wenn sie mit den Daten unmittelbar interagieren und ihrem Know-how und ihrer Intuition folgen. Gelingt es dann noch, das Wissen innerhalb eines Forschungsteams weiterzugeben, können Projektgruppen schneller entscheiden, welche Experimente als nächstes durchzuführen sind. Infinity Pharmaceuticals macht es vor – mit dem interaktiv-visuellen Analyse-Tool von Spotfire. Mehr dazu hier.

Herausgepickt

„Im Sinne eines allgemeinen Feedbacks möchte ich Ihnen versichern, dass das Paperless Lab Seminar in Basel vom letzten Freitag sehr interessant und lehrreich war, eine professionelle Organisation dahinter stand und ganz allgemein eine ideale Plattform zum Treffen und Austausch mit Analytiker-KollegInnen darstellte. Die Präsentationen waren aufgrund ihrer Kürze prägnant, fokussiert und inhaltlich wie auch präsentationstechnisch meist auf hohem Niveau.“

Vialis offeriert Ihnen ein kostenloser Vortrag zum Thema papierloses Labor, melden Sie sich dazu auf unserer Webseite unter www.vialis.ch/de/PL an.

...in ein Papierloses Labor spielen zusammen.

Vialis hat Ihre neuen Büros in Liestal bezogen.
Mehr hier

Seid dem 2. März 2006 sind wir nach ISO 9001:2000 zertifiziert.
Zertifikat englisch
Zertifikat deutsch

Am 27. Oktober 2006 führen wir ein Paperless Lab Solution Forum zum Thema Papierloses Labor in Basel durch „Was ist der Gewinn beim Wechsel zum papierlosen Labor“.
Mehr hier

Partner News

Labtronics
Case Study: CDS to LIMS Integration Saves Company 9,000 Man Hours
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Discover how an integration solution enabled an international pharmaceutical company to reduce the time spent processing chromatography data by 52%, while improving the accuracy and availability of data.
Read more

Integrating Simple Instruments: More than just a Serial Port Connection
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Learn how the greatest value of integrating your simple instruments, such as balances and pH meters, is not data collection but rather 'real time' procedural control and information integration.
Read more

Herausgepickt

„Herr Franz Breitfeld, LIMS Verantwortlicher der CarboGen AG, schätzt, dass durch die Machbarkeitsstudie und die konzeptionelle Planung der Vialis GmbH in Liestal  das Investitionsvolumen für die Einführung des elektronischen Labors in der analytischen Entwicklung sowie der Qualitätskontrolle um ca. 30 % reduziert werden konnte. Nachhaltig konnten durch das papierlose System die Analytikkosten für pharmazeutische Entwicklungsprojekte um bis zu 25 % gesenkt werden. Die Steigerung der Qualität der Arbeiten durch das elektronisches System kann man gar nicht beziffern, ist jedoch enorm.“

Fallstudie Vialis GmbH
Carbogen/Amcis Strategischer Entscheid für LIMS und Chromatographie Daten Management System Ausbau