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Part 11 complianceas a property of the run.

Electronic records that are attributable, tamper-evident, and retained. Electronic signatures bound to identity, meaning, and time. Built into every step, not added at the end.

Book a demoWhere it sits in the chain
Where Part 11 controls act in the chain
  1. Approved requirement
  2. Test scripts
  3. Autonomous execution
  4. You take over
  5. Defects logged
  6. Signed OQ / PQ report
Records

Every record is created under control.

Each executed step writes a record at the moment it happens. The record is hashed, time-stamped, and never edited in place.

  • Append-only, hash-chainedThe audit trail cannot be edited. A correction is a new entry.
  • Secure UTC time stampsEvery entry carries a single, consistent time source.
  • Accurate and complete copiesExports match the record on screen, in full.
OQ-2214 · Evidence log6 of 96 steps shown
StepActionResultEvidence
1Log in as QA-02Pass9f3c…a71e14:31:02 UTC
2Open batch record BR-2219Pass4b0e…c2d914:31:19 UTC
3Enter sample result 4.2 mgPassd71a…08f414:31:44 UTC
4Approve record · Priya N.Passe2c8…5b1314:33:10 UTC
5Verify audit entryPass77ad…f90c14:33:41 UTC
6Print certificateFail · DEF-0311c5f…3e6a14:34:05 UTC
Every entry links back to its requirement and script.Locked
Signatures

A signature that means something.

A Part 11 electronic signature is not a click. It carries who signed, what it means, and when, bound to the record.

  • Two componentsSSO identity plus re-authentication at the moment of signing.
  • Meaning shownApproved, Reviewed, Rejected, or Authored appears with the signature.
  • Linked to the record hashA signature cannot be moved to another record.
Signature manifest · OQ-22144 of 4 signed
Risk levels approvedMeaning: Approved
Priya N.2026-09-10 09:12 UTC7a2e…41bd
Scripts approvedMeaning: Approved
Priya N.2026-09-11 15:40 UTC4b0e…c2d9
Impact assessment (DEF-031)Meaning: Approved
Priya N.2026-09-13 11:02 UTCe2c8…5b13
OQ-2214 report approvedMeaning: Approved
Priya N.2026-09-12 14:32 UTC9f3c…a71e
Access and authority

Fixed roles. SSO only. A read-only seat for the auditor.

Every action checks against a fixed role. There are no shared accounts and no local passwords.

  • Role-based accessEach role sees only what it needs.
  • Authority check before signingThe system checks the role before accepting a signature.
  • No shared accountsEvery action is attributable to one person.
Role matrix5 roles · 6 permissions
RoleApprove
scripts		ExecuteTake
over		Sign
report		ExportManage
users
Validation lead
Tester
QA approver
Auditor
Admin
Beyond Part 11

Part 11 in the US. Annex 11 in the EU. One control set.

21 CFR Part 11Records, signatures, and audit trail.
EU Annex 11§ 9 audit trails, § 12 security, § 14 electronic signature.
GAMP 5 second edition and FDA CSARisk-based, critical thinking.

ALCOA+ data integrity principles apply to all captured evidence.

Evidence and audit trail
Where this fits

The controls behind this page.

PlatformE-signatures and complianceWhat gets signed, and how a signature is bound to a record.PlatformEvidence and audit trailThe append-only, hash-chained trail behind every record.TrustTrust and securityHosting, data residency, and access control in detail.

Questions about Part 11.

If your question is not here, ask us. We reply within one working day.

Is Merivane itself validated?

Vendor validation package available for your supplier assessment. SOC 2 Type II is in progress.

Are AI actions electronic records?

Yes. Each action is attributed to the agent, evidenced, and reviewed and signed by a person.

Can we use our own e-signature service?

Under review.

Where are records stored?

Single-tenant, in the region you choose.

Now onboarding validation pilot partners

See a full run on one of your systems.

Bring one approved requirement. We show you the chain end to end, on a system you already use, in under an hour.

Book a demo
Reply timeOne working day
FormatLive run, 45 minutes