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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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Are paper batch records slowing you down?

By Michael Morrison, March 31, 2020

HOW BATCH RECORDS ARE MANAGED

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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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Are paper batch records slowing you down?

By Michael Morrison, November 13, 2018

How are batches managed?

 

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Cloud Computing in a Regulated Environment

By John Hannon, October 25, 2018

How can cloud computing be used in a highly regulated environment?

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The Low Down on a New Packaging Serialization Standard

By John Hannon, January 4, 2018

Nine vendors and one end user recently conducted pilot tests to develop, evaluate, and validate a new serialization standard, PSS 1.0, officially released in November 2017. This group, known as the Open Serialization Communication Standard Group (Open-SCS), advocates that PSS 1.0 minimizes customization of plant-to-enterprise interfaces (Levels 3 and 4), thereby shortening the integration process by months and improving scalability and repeatability.

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The Data Life Cycle

By John Hannon, October 10, 2017

The ISPE Good Practice Guide on Records and Data Integrity defines a data life cycle consisting of:  Creation — Processing — Review, Reporting, and Use — Retention and Retrieval — Destruction

A robust data integrity program ensures data integrity across this entire life cycle. Such a program would include a risk-based analysis of all data flows to identify, assess, mitigate, and communicate potential data integrity issues. Systems supporting the data integrity should be validated for their intended use, and boundaries for the data should be identified. Throughout the data process, data must be secured from modification or deletion by unauthorized personnel, and changes to the data must be captured in audit trails or through appropriate procedures.

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From Dragon to Chameleon

By John Hannon, September 21, 2017

Implementing a Serialization Database Across an Entire Enterprise.

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How to Understand ASTM E2500