Validation & compliance
Any software used in your quality system must be validated for its intended use. XyReg ships the validation package so you are not writing it from scratch.
What is included
- Intended use statement and risk assessment following AAMI TIR80002-2.
- AAMI TIR80002-2 risk-based assessment and supplier assessment pack.
- Installation, operational and performance qualification protocols with pre-filled expected results.
- 21 CFR Part 11 assessment covering electronic records, electronic signatures and audit trails.
Revalidation on updates
When XyReg releases an update, the validation module tells you what changed, which of your validated functions are affected and which test scripts need to be re-executed. Unaffected functions are documented as such with rationale.
The result is a signed revalidation record generated in hours, not a full requalification project every release.
Audit trails and electronic signatures
Every create, change, approval and deletion is written to an append-only audit trail with user, timestamp, previous value and reason for change. Signatures capture the signer's printed name, date, time and meaning of the signature.