Compliance and validation
Built for the requirements you are audited against
Phønix Audit supports your compliance. The responsibility for procedures and validation stays with you, and we give you the material to do it.
Thermal processing records
21 CFR Part 113 requires a processing record for every load of low-acid food in hermetically sealed containers, reviewed and signed within a set time.
- Temperature and time for every cycle, with F0
- Deviations from the scheduled process are flagged
- Review deadline in working days, with overdue cycles shown
- Retention period enforced: records cannot be deleted before it ends
Electronic records and signatures
21 CFR Part 11 and EU GMP Annex 11 set the rules for electronic records and signatures.
- Unique user accounts, roles and password policy
- Electronic signatures with name, date, time and meaning
- Tamper-evident audit trail with periodic review
- Settings and licence sealed with a checksum; changes outside the program are detected and logged
- Backup and restore that keeps users and audit trail
Validation package
Every release comes with the documents you need to validate the system in your own quality system:
- User requirement specification (URS) with references to Part 11, Part 113 and Annex 11
- Installation qualification (IQ) that checks the installed files against a signed manifest
- Operational qualification (OQ) that runs automated test cases on an isolated copy and produces a signed report
- Traceability matrix from requirement to test, and a change log that lists which tests to repeat after an update