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Compliance

Audit log, e-signatures, 21 CFR Part 11

Built for regulated environments — 21 CFR Part 11 workflows, immutable audit log, e-signatures with non-repudiation, and exportable trails.

What it does

Built for the way labs actually run

ResearchLab is built for regulated environments. The system supports 21 CFR Part 11 workflows for electronic records and signatures, with audit trails that capture every state-changing action and exports that survive inspection. We provide a validation summary document and a documented change-control process for qualified customers.

Every state-changing action — creating, editing, signing, archiving, transferring — is captured in an immutable audit log. The log records who, what, when, and the before-and-after state of the record. E-signatures require multi-factor authentication and include non-repudiation, so a signer cannot later deny having signed. The audit trail can be exported in standard formats for inspection on demand.

How it works

Three steps from setup to sign-off

1

Configure for compliance

Enable 21 CFR Part 11 workflows, e-signatures, and the audit log. We provide validation docs.

2

Work as normal

Every action is captured automatically. No extra steps for your lab members.

3

Export for inspection

Export the audit trail in standard formats on demand. Survive any inspection.

Why it matters

Benefits that compound

  • Immutable audit log captures every state-changing action
  • E-signatures with multi-factor authentication and non-repudiation
  • 21 CFR Part 11 workflows for electronic records
  • Exportable audit trails for inspection

Try Compliance today

Start a 30-day free trial and explore compliance with the rest of ResearchLab.