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John Hannon

Recent Posts

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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Serialization: Are You Ready For Changing Regulations?

By John Hannon, April 12, 2016

If the pharmaceutical distribution network is at risk, so is patient safety. With counterfeit drugs on the rise, serialization programs are being implemented to safeguard the integrity of product reaching the market. Serialization also provides better controls to communicate recall information should it become necessary.

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How to Understand ASTM E2500