Validate Faster.
Comply Smarter.
Hai-Trust automates GxP compliance — AI-driven document review, 21 CFR Part 11 electronic signatures, and full traceability across your validation lifecycle.
Everything your quality team needs
A complete validation suite designed for pharmaceutical, biotech, and medical device teams.
Our AI reads every requirement against regulatory guidelines, automatically flagging GxP gaps, ambiguities, and missing clauses with specific remediation steps.
Automatically links URS → FS → test protocols. Instantly expose gaps in coverage with zero manual mapping.
Every action, workflow step, and user event is permanently recorded in an append-only historical database.
Complete electronic signature blocks with signer identity, timestamp, role, and formal meaning — injected directly into standard output formats.
Strict document lifecycles from Draft → In Review → Approved → Obsolete with full version history.
Real-time project metrics — approval counts, pending reviews, and audit trail dashboards updated continuously.
See AI review in action
Select a validation requirement to see how our AI identifies regulatory gaps in real-time.
The audit trail does not implement write-once storage controls. Database administrators can modify log entries directly, violating 21 CFR Part 11 integrity requirements.
Implement column-level cryptographic hashing or migrate audit tables to an append-only ledger with WORM enforcement.
Three steps to compliance
Streamline your entire validation lifecycle from planning through final release.
Import existing documents or author new validation deliverables using AI-assisted templates with built-in compliance checks.
Run AI-powered regulatory scans to identify gaps, then execute test protocols with digital evidence capture and automated logging.
Apply Part 11 compliant e-signatures and compile a complete, audit-ready digital validation package.
Measurable results
Ready to transform your validation process?
See how Hai-Trust can streamline your GxP compliance. Schedule a personalized demo with our team.