Freezerworks is written and tested in according to FDA regulations and guidance documents, including GMP Quality System Regulation (21 CFR Part 820), Electronic Records – Scope and Application (21 CFR Part 11), and General Principles of Software Validation (FDA Final Guidance for Industry). Click here for more information.
Is Freezerworks 21 CFR Part 11 compliant?
- All Editions of Freezerworks make it easy for you to stay in compliance with 21 CFR Part 11.
- The unmodifiable audit trail captures every modification made to every data field in Freezerworks and user authentication is required upon login.
- See our Quality Assurance web page for our 21 CFR Part 11 statement.