
- BioPharm International-10-15-2016
- Volume 2016 eBook
- Issue 2
Data Integrity Challenges in Manufacturing
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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Articles in this issue
almost 9 years ago
Cell Line Quality Technologiesalmost 9 years ago
Investigation Effectiveness Drives Human Performance Excellencealmost 9 years ago
Evaluating Technology and Innovation in Biopharmaceutical Manufacturingalmost 9 years ago
Seeking Accelerated Biosimilar Characterizationalmost 9 years ago
Plant-Made Pharmaceuticals—Accelerating Drug Development Globallyalmost 9 years ago
Testing the BrothNewsletter
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