Trust & Security
Security at ProveWise
ProveWise controls regulated documents for life-sciences teams, so integrity and access control are the product — not an add-on. This page describes the controls that are built into the platform today. It reflects the current implementation; where something is on our roadmap rather than shipped, we say so.
Records & signature integrity
- Hash-chained audit trail — every action is appended to a tamper-evident, hash-linked log (21 CFR Part 11 §11.10(e)); breaking a link is detectable.
- Content-hash on every version — each document version is fingerprinted with SHA-256, so any later change is provable.
- Electronic signatures bound to the version's content hash, with re-authentication at signing and segregation of duties.
- Audit mirror — every audit record is written a second time to a separate immutable store; with an Object-Lock bucket configured the copy is storage-enforced write-once, and the platform reports which it is.
Tenant isolation
- Multi-tenant by design — every record is scoped to a tenant on every query.
- PostgreSQL Row-Level Security enforces isolation at the database layer, defence-in-depth behind the application filter.
- Per-request tenant context resolved at authentication and carried through the request.
Access control & identity
- Role-based access control with least-privilege permissions (author, reviewer, approver, QA, admin, viewer, trainee).
- Optional SSO (OIDC) with step-up re-authentication at electronic signing.
- MFA — TOTP authenticator enrolment on user accounts.
- Session idle-timeout and login brute-force rate-limiting.
Application hardening
- CSRF protection — double-submit token on every state-changing request.
- Output sanitization — imported/rendered HTML is sanitized against an allow-list to prevent stored XSS.
- Security headers middleware and production boot-guards (secret-key enforcement, docs/metrics locked down).
Data protection
- Encryption in transit (TLS) between clients and the service.
- Integrity + dedup — content-addressed storage; identical bytes are stored once and verified by hash.
- Configurable retention with a §11.10(c) lock that the audit trail can never be deleted.
- Tenant data export for portability and offboarding.
Compliance alignment
- Built to help you meet 21 CFR Part 11, EU GMP Annex 11, and GAMP 5 (Category 4).
- Ships with a formal validation pack — URS, FS, risk assessment, traceability matrix, and executable OQ scripts.
- IQ / OQ / PQ protocols with recorded execution evidence, carrying signature blocks for your qualified persons to sign.
Honesty note. ProveWise is software that helps you operate a compliant, validated document-control process. Holding a ProveWise subscription is not itself a regulatory certification. Where deployment-dependent controls (such as hosting encryption-at-rest and region) apply, they follow your chosen infrastructure — see our Sub-processors list.
Report a vulnerability: security@zentrum24.com. We welcome responsible disclosure and will acknowledge reports promptly.