Audit & Compliance

Bulletproof 21 CFR Part 11 & Annex 11 Compliance.

When the inspector asks for your execution records, hand them a secure, immutable, and fully traceable digital package instead of a box of binders.

Built for the Harshest Inspections

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Compliant Electronic Signatures

Two-factor authentication required for all critical execution steps. Every signature clearly marks the printed name, date, time (to the second), and the meaning of the signature (e.g., "Executed By", "Reviewed By").

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Immutable Audit Trail

Every creation, modification, or deletion of a record is captured in an independent, immutable database. It records Who, What, When, and Why, and cannot be altered even by system administrators.

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Granular Role-Based Access

Strictly enforce separation of duties. Ensure that the person who executes a test cannot be the same person who approves the final validation report.

The Risk of Paper
  • Illegible handwriting and missing dates
  • "Backdating" signatures after a protocol is completed
  • Losing critical pages of an executed protocol
  • Spending weeks preparing for a regulatory inspection
The Security of ValiTrail
  • System-enforced timestamping prevents backdating
  • Data integrity guaranteed by cryptographic hashing
  • All validation packages securely stored in the cloud
  • Generate inspector-ready reports in a single click