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Pharma Express: Volume 2 Laboratory Controls & Data Integrity
Paperback
Series: Pharma Express
Business GeneralMedical Reference
Publisher: Independently Published
Published: Jan 8 2026
Pages: 210
Weight: 0.63
Height: 0.44 Width: 6.00 Depth: 9.00
Language: English
Pharma Express - Volume 2: Laboratory Controls & Data Integrity delivers a clear, inspection-ready guide to how pharmaceutical laboratories are expected to operate-and how regulatory confidence is built, tested, and lost through data.
- How regulators evaluate laboratory controls and data integrity
- What ALCOA+ really means in daily laboratory operations
- How to manage OOS, OOT, invalidations, and retesting without compromising integrity
- The difference between error, fraud, and poor systems
- Why audit trails, access control, and validation matter more than policies
- How warning letter patterns emerge-and how to avoid them
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