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Brian Stephens

Recent Posts

Is CSA Really a Game Changer for the Life Science Industry?

By Brian Stephens, June 11, 2020

Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software Guidance – Is it the solution to arduous validations that the life science industry has been waiting for from the FDA?

Least Burdensome Approach to Validation – the Food and Drug Administration (FDA) has been pushing this concept onto life science companies for the past two decades, with less-than-desired results. The FDA's upcoming CSA guidance promises to be a useful tool to help the industry finally achieve this elusive goal.

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Whitepaper: 6 Mistakes Made When Implementing Serialization

By Brian Stephens, January 22, 2019

The FDA’s 12 month delay in enforcing the Drug Supply Chain Security Act (DSCSA) requirement for all RX products in cases to be serialized was meant to give industry more time to comply with the new regulation, but this extra time does not modify the Act or change the enforcement date of its later provisions.  The extra time may seem sufficient for companies who have delayed their serialization efforts, but many companies are finding serialization to be more involved than they expected, as they encounter unforeseen issues and delays during several phases of their project.  These problems have several causes, including the immature technology being used, the miscalculation of resources required to implement the system, and the failure to identify the system’s true capabilities until it is too late.  This whitepaper discusses common mistakes made before, during, and after the implementation of a serialization system and offers ideas to minimize or eliminate the problems associated with adding serialization to a supply chain.

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How to Understand ASTM E2500