21 CFR PART 11 · EU ANNEX 11 · GAMP 5

Every document.
Provably controlled.

The inspection-grade document vault for pharma consultants and small life-science companies.

BUILT FOR THE PEOPLE WHO CARRY THE AUDIT

Your clients' quality system.
Your reputation.

Consultants run document control for many clients at once. Small companies run it without a QA department. Both answer to the same inspector. ProveWise gives each client an isolated tenant — their documents, their audit trail, their signatures — and gives you one calm place to run them all.

  • A separate workspace per client — isolation enforced by row-level security in the database
  • Ten interface languages for global teams
  • Nothing to install for your client — a browser is enough
A consultant working beside a pharmaceutical cleanroom

HASH-CHAINED AUDIT TRAIL · §11.10(e)

Nothing breaks the chain.

Every action links to the one before it, sealed by a cryptographic hash. Change a single byte of history and the chain announces it — to you, and to the inspector. The trail can never be edited. Never deleted. That's not a setting. It's the law, built in.

ELECTRONIC SIGNATURES · §11.50 / §11.70

Signed means sealed.

Every signature is bound to the exact bytes of the document it approved — its content hash. Re-authentication is required at the moment of signing. The manifestation shows who, when, and what the signature meant. Swap the file afterwards and the seal is visibly broken.

THE REAL PRODUCT

Calm on the surface.
Rigorous underneath.

No mockups here — this is the shipping interface. Light by default, dark by choice, in ten languages.

ProveWise documents workspace with folder tree and inline reader
The document workspace — folders, statuses, inline reader
Compliance posture page with readiness ring
Compliance posture — screen-share it with an inspector
Change request detail with workflow rail
Change control — a real state machine, not a checkbox

CONTENT-HASH BINDING

The file is the fingerprint.

The moment you choose a file, ProveWise computes its SHA-256 fingerprint — before it even uploads. That fingerprint follows the document through review, approval, signature and archive. Every copy can be verified against it, forever.

Glass document pane with etched hexadecimal fingerprint
0URS requirements traced
0Inspection-grade surfaces
0Interface languages
§11.10(e)Hash-chained audit trail
A sterile pharmaceutical cleanroom corridor

ONE VAULT · EVERY CORNER OF THE INDUSTRY

Wherever your clients work,
their documents are covered.

ProveWise speaks the document language of all twenty-two segments of the sterile pharmaceutical ecosystem.

CDMOsCROs Clinical trial sitesSuppliers Equipment manufacturersPackaging Logistics & cold chainPayers PBMsRegulatory authorities Ethics & IRBCentral labs PharmacovigilanceAcademic centers InvestorsIP law firms ConsultantsPreclinical & GLP labs Process developmentEngineering & CQV BiotechsMedical device
A bound stack of validation documents

VALIDATION PACK · URS → FS → TM → OQ

The binder is already written.

ProveWise ships with its own CSV validation pack — user requirements, functional specs, a live traceability matrix and ready-to-execute OQ scripts. When the client's auditor asks "is this system validated?", you have a running head start instead of a blank project. And every document and change request exports its own audit pack, ready for the inspector's table.

  • 150 URS requirements, traced end to end
  • Per-document and per-DCR audit-pack PDFs
  • Retention locked by regulation — the audit trail is never deleted

PRICING · PER SEAT · CANCEL ANYTIME

Simple per-seat pricing.

Every plan includes the full Part 11 audit chain, sealed e-signatures, the validation pack, and pooled document storage. Pay yearly and save 20%. Start with the seats you need today — add more anytime, prorated.

Solo Consultant

$19

per seat / month

10 GB POOLED STORAGE

  • Hash-chained audit trail & sealed e-signatures
  • Full document lifecycle and change control
  • Per-document and per-DCR audit packs
Choose Solo Consultant

GMP Audit House

$99

per seat / month

1 TB POOLED STORAGE

  • Everything in Consulting Firm
  • 10× the storage again, for a full audit house
  • Priority support & onboarding
Choose GMP Audit House

PRICES IN USD · YEARLY BILLED UPFRONT AT 20% OFF · ADD OR REMOVE SEATS ANYTIME, PRORATED · STORAGE POOLED PER WORKSPACE · 14-DAY PILOT, NO CARD REQUIRED

Fourteen days.
Your documents, provably controlled.

Your own tenant, your folders, your audit chain — running in minutes. No card required to begin.

TENANT ISOLATED · AUDIT CHAINED FROM THE FIRST EVENT · PER-DOCUMENT & AUDIT-PACK EXPORT ANYTIME