- Controlled documents
- Templates are versioned, reviewed and approved by different people, with a change reason and an effective date.
- Electronic signatures
- Password and authenticator code at signing, a stated meaning, and a binding to the signed content. Built to support your 21 CFR Part 11 and ISO 13485 requirements.
- Attributable records
- Unique accounts, permissions per site, and signing rights granted separately from admin rights.
- Audit trail
- Every change is hash-chained, verifiable and exportable.
- Phase reviews
- Gate decisions are signed and dated, approved phases are locked, and conditions are tracked to closure. This fits APQP, AS9145 and stage-gate reviews.
- Corrective action
- 8D structure, linked to the failure, closed with a signature.