Append-only ledger
Every state change — a published SOP, a closed CAPA, an inspection answer, an incident transition — is written once and never edited.
Audit Trail
Every state change, hash-chained. Verifiable on your auditor's machine.
Each event is appended to a ledger as canonical JSON — actor, action, content hash, UTC timestamp, and the hash of the previous event. Tamper with one row and every subsequent hash breaks.
21 CFR Part 11-shaped · EU GMP Annex 11 · ALCOA+ data integrity
Integrity that doesn't rest on trusting us.
Hash-chained entries
Each entry carries the hash of the previous one. Altering any historical row breaks every hash after it, visibly.
Content-bound signatures
E-signatures include a hash of the exact bytes signed, with re-authentication and typed signature meanings.
Chain proof in every export
PDFs and evidence packs embed the chain head. The artifact your auditor holds carries its own proof.
Independent verification
Auditors re-derive the chain on their own machine. The trail verifies or it doesn't — there is no "trust us" step.
Export-on-cancel
Full workspace exports with chain proof are available if you leave. We don't hold your audit trail hostage.
Record. Chain. Verify.
- 1
Record
Every action writes a canonical-JSON event with actor, action, subject hash, and UTC timestamp.
- 2
Chain
Each event includes the previous event's hash, forming a tamper-evident chain.
- 3
Verify
Anyone with the export can re-derive the chain independently and confirm nothing changed.
What this satisfies
- 21 CFR Part 11-shaped
- EU GMP Annex 11
- ISO 27001 logging
- ALCOA+ data integrity
"Shape" means we mirror the regulation's evidence, signature, and audit-trail requirements in our data model. See Trust & Security for the current certification state.
“Our auditor re-derived the chain on his own laptop and stopped asking for screenshots. That was the shortest evidence review we've ever had.”
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