Facilitating regulatory compliance in product development and submission planning with PLM
Name Dr. Christina Schröder
Company Oracle
Email christina.schroeder(at)oracle.com
Abstract
Product development in the pharmaceutical industry is characterized by long cycle times, a vast amount of diverse data, and numerous regulatory requirements. It is difficult to keep track of a product throughout its lifecycle stages. Failing to comply with regulatory requirements can be very costly and in the worst case leads to stop-ship situations - sometimes caused by rather small and avoidable data inconsistencies.
Product Lifecycle Management (PLM) helps to plan and execute drug product development, addressing key areas from collaboration across departments and with external partners through submission preparation support to efficient change management pre and post market launch. Industry-specific features include support for clinical trial supply, quality and compliance improvement, packaging and labeling, and much more.
PLM can be integrated with other data management and authoring tools, allows to plan and monitor important aspects of product development without disrupting existing practices and workflows. PLM eliminates bottlenecks in gathering and collating information, avoids tedious and error-prone data collection and transformation in spreadsheets. Above all, PLM provides a single source of truth for all product-related data: tasks and changes are transparent to all persons involved. As a result, life science organizations can be confident that the data submitted to regulatory bodies are consistent with the product that is eventually produced and marketed.