21 CFR Part 11 + Applied Therapeutics rejection

21 CFR Part 11 requires complete audit trails for any electronic record submitted to the FDA. Applied Therapeutics submitted a new drug application; FDA discovered that a vendor had deleted audit trails two days after FDA preannounced its inspection. The application was rejected.

Use: E-0046, C-0025 (verification regime; data inadmissibility regardless of content).

Original whitepaper reference: [76]