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APIC data integrity guidance for CSV and DI teams
APIC data integrity guidance comes in two documents that only work as a pair. The Practical risk-based guide for managing Data Integrity (Rev.2, April 2022) sets the method: map the processes, grade the data, sort systems into four categories, check the gaps against minimum controls, then score the failure modes. The Data Integrity FAQ (V3, October 2025) settles the narrow arguments that come up in audits and self-inspections. Plenty of computer system validation (CSV) programs still treat data integrity as a checklist stapled to the back of a validation report. The APIC material takes a different line. It calls data integrity (DI) continuous governance, then hands CSV teams a way…
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Drug Development Documentation: Protocols, Raw Records, and Study Reports That Pass Inspection
Most development findings aren’t about bad science. They’re about paperwork. When an inspector writes something up, the cause is usually mundane. A protocol element nobody filled in. An acceptance criterion so loose it can’t fail. A raw record written three days after the fact. A report whose numbers quietly disagree with the notebook underneath it. This piece walks the three documents that actually carry a development program: the protocol, the raw records, and the study report. It also covers where small molecules and biologics need to split off, because one shared template for both guarantees gaps somewhere. What are the key documents in drug development? Three of them: the study…
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FDA CMC Requirements: What Reviewers Actually Check
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