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Real-World Data IntegrityCase Studies
Learn from real regulatory challenges and discover how TechyPharma solutions help organizations achieve and maintain data integrity compliance.
Clock-back + Shared Login + Audit Trail Disabled
Chromatography Data Integrity Issue
Analysts changed HPLC computer date/time, re-ran analyses, and reported only passing repeats. Initial results were overwritten/deleted with no user traceability.
USFDA Warning Letter - Data Deletion & Audit Trails
Electronic Files Could Be Deleted
Electronic files from lab systems could be deleted with no adequate controls. HPLC/GC control software did not have appropriate audit trails enabled for significant changes.
No Audit Trail Review -> Only Passing Events Printed
Selective Data Capture in Manufacturing
Operators not recording/printing negative filter integrity tests; only "pass" evidence was retained. Lack of electronic raw data and audit trail review by Production/QA.