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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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FDA CMC Requirements: What Reviewers Actually Check
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