Is Chromperfect 21 CFR Part 11 Compliant? | File-Based vs Database Edition Explained

When laboratories start looking into compliance with 21 CFR Part 11, one of the first questions they ask is whether Chromperfect meets the requirements for electronic records and audit trails.

This video explains how Chromperfect supports compliance and compares the two main configurations — the standard file-based system and the Database Edition.

The Database Edition adds enhanced security for regulated environments, storing all chromatographic data, methods, and audit trails in a secure SQL database. This design prevents external modification, enforces user authentication and role-based access, and maintains a complete, immutable audit history.

The video also highlights the European equivalent, EU Annex 11, which mirrors the same technical principles as 21 CFR Part 11 but includes a few extra procedural requirements related to system validation and management.

If your laboratory operates under regulatory oversight or requires strong data integrity controls, this short overview explains how Chromperfect provides the technical foundation for both 21 CFR Part 11 and EU Annex 11 alignment.

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