Compliance Made Simple: CFR 21 Part 11 Built Into Chromperfect 10

Intro

With Chromperfect 10, compliance isn’t an afterthought — it’s built in. For the first time, full CFR 21 Part 11 support is integrated directly into the software, eliminating insecure workarounds and giving labs a straightforward path to regulatory confidence.

Secure Data, Always - Chromperfect CFR 21 Part 11 compliance

Version 10 introduces full data locking in a secure database:

• Raw and processed data are automatically stored in a tamper-evident format.

• No unsecured files sitting in local folders.

• Auditors can verify data integrity instantly.

Complete Audit Trail

Every action is recorded with time, date, and user credentials, providing a comprehensive, non-editable audit trail that meets FDA and international compliance standards.

Simplified Validation

With built-in CFR 21 Part 11 compliance, labs can:

• Avoid manual file handling.

• Reduce time spent on compliance documentation.

• Pass audits with less stress and greater confidence.

Ensure your chromatography data meets the highest regulatory standards with Chromperfect CFR 21 Part 11 compliance. Contact us to learn how