ProveWise · Document management (EDMS)
ProveWise — a 21 CFR Part 11 electronic document management system (EDMS)
A validation-ready electronic document management system built for 21 CFR Part 11, EU Annex 11, and GAMP 5 from the ground up — so your controlled documents, signatures, and audit trail live in one system, not three.
- 21 CFR Part 11
- EU Annex 11
- GAMP 5
- ALCOA+
- Data integrity
What ProveWise does
Controlled document lifecycle
Draft → review → approval → effective → archived, with enforced versioning and change control.
Part 11 electronic signatures
Re-authenticated e-signatures bound to the exact version’s content hash.
Tamper-evident audit trail
Every record-changing event is sealed with a SHA-256 hash chained to the previous entry.
Change requests & workflows
Configurable review and approval workflows with a documented reason for every change.
Formal CSV validation pack
Ships with a URS, traceability matrix, and OQ pack for your qualification.
Who it’s for
Built for QA, document control, and validation teams in sterile and regulated pharma manufacturing who need an inspection-ready EDMS.
Frequently asked questions
- Is ProveWise 21 CFR Part 11 compliant?
- ProveWise is built around Part 11: re-authenticated electronic signatures, a tamper-evident hash-chained audit trail, and controlled document workflows. It ships with a formal CSV validation pack so you can qualify it in your own environment.
- How is ProveWise different from a shared drive?
- A shared drive stores files; ProveWise controls them — enforced versioning, approval workflows, electronic signatures, and an audit trail that proves who did what, when, and why.
- Does ProveWise support EU Annex 11 and GAMP 5?
- Yes. It is designed for 21 CFR Part 11, EU Annex 11, and GAMP 5, with ALCOA+ data-integrity principles throughout.
Ready to see ProveWise in action?
Open ProveWise