Procedure and implementation
Strict procedures are essential when handling sensitive data. Vialis takes such measures into account, making sure that they can be easily and safely carried out. Planning and implementation of your specified procedures are made according to the strict GAMP guidelines – whether operations, maintenance, customization or system extension. Our specialists appreciate client’s needs, no matter how complex, and can smoothly implement solutions.
When does it apply?
21 CFR Part 11 was issued by the American Food & Drug Administration on August 20th 1997, and is therefore binding for all companies that produce...
...in or export to the United States that either use electronic records for regulated activities, use a paperless system for documentation of their quality records or want to submit electronic files to the FDA. Recent guidance issued by the FDA (in September 2003) is in alignment with the new risk based approach and focuses more on predicate rule requirements (GxP) and risk based analysis for the decision when Part 11 applies. Thus making a thorough documented analysis of your systems even more important.
What does it cover?
The goal of 21 CFR Part 11 is among others to make sure, that the authenticity, integrity, and, when appropriate, the confidentiality of electronic records is guaranteed. In addition...
...In addition it defines the requirements that have to be met so that the agency considers electronic signatures to be the legally binding equivalent of the individual’s handwritten signature.
21 CFR Part 11 is split in three parts:
General Provisions
describing the scope, implementation and definitions.
Electronic Records
with controls for open and closed systems, signature manifestations and signature / record linking. This covers among others system validation, system access, audit trails, training requirements and change control.
Electronic Signatures
with general requirements, E-sig components and controls and controls for identification codes & passwords. This covers the equivalency of E-sigs with handwritten signatures, the required components for E-sigs (including biometrics) and controls for identification codes & passwords.
21 CRF PART 11
GUIDANCE FOR INDUSTRIES
EU-GMP-ANNEX 11
40 CFR PARTS 3,51
OECD GLP CONSENSUS
PIC/S GUIDANCE PI 011-2