PHARMA & REGULATORY 9 min read August 2026
21 CFR Part 11 Electronic Batch Records (eBR) Checklist for API Pharma Plants
MR
Mahesh RanaFounder, CEO & MD, Nexova Technologies
“How to meet stringent FDA 21 CFR Part 11 and EU GMP Annex 11 electronic record standards: dual cryptographic signatures, immutable audit trails, and system access governance.”
Key Requirements of FDA 21 CFR Part 11 for Digital Manufacturing
For Active Pharmaceutical Ingredient (API) and bulk drug manufacturers in Gujarat exporting to the US and Europe, electronic records must be as tamper-evident and legally binding as handwritten signatures.
Dual Maker-Checker Electronic Signatures with distinct password/biometric prompts.
Immutable Computer-Generated Audit Trails recording date, time, operator ID, and previous vs new value.
Authority Checks to ensure only authorized personnel can approve recipe adjustments.
Device & Scale Verification locking terminals if calibration certificates are overdue.
Key FAQ Summary
Are Nexova audit logs tamper-proof against database administrators?
Yes. Nexova uses append-only cryptographic hashes (SHA-256) for audit trails, ensuring historical logs cannot be edited or deleted even by database administrators.
