Data Integrity Challenges in Manufacturing

October 15, 2016

BioPharm International

Volume 2016 eBook, Issue 2

Page Number: s31-s34

Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.

Manufacturing systems should be designed using the principles of good documentation practice to ensure data integrity. Industry experts describe issues with validating, using, and auditing paper and electronic records. Records must meet the core principles of ALCOA+ (data must be attributable, legible, contemporaneous, original, accurate, complete, consistent, and enduring).

 

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