Hai-Trust modernizes GxP compliance — delivering AI-powered requirements analysis, 21 CFR Part 11 electronic signatures, and audit-ready documentation across your entire validation lifecycle.
Legacy tools and paper-based processes create bottlenecks at every stage of the validation lifecycle.
A single platform connecting every step of the validation lifecycle — from requirements authoring to test execution and regulatory approval — with AI intelligence built into every layer.
An integrated suite purpose-built for regulated industries — not adapted from generic project management software.
AI analyzes every requirement for testability, catches duplicates, and scores quality before submission — cutting review cycles dramatically.
Immutable electronic signature chains with signer identity, timestamp, role, and legally binding meaning — always audit-ready.
Bi-directional traceability from URS through test execution. Every requirement linked to test cases and results, always current.
Version-controlled documentation with structured review workflows, templates, and lifecycle management from draft to approved.
Capture, classify, and resolve test deviations with root cause analysis and corrective action tracking that satisfies regulatory expectations.
Real-time visibility into every project's compliance status — from planning milestones to test pass rates and open deviation counts.
Hai-Trust guides your team through every phase of the validation lifecycle in a single, connected platform.
Define scope, risk assessments, validation approach, and milestones aligned to your regulatory framework.
Write requirements, upload SOPs, and generate test cases — with AI checking quality at every step.
Run test protocols with structured evidence capture, deviation logging, and real-time pass/fail tracking.
Generate validation summary reports, apply 21 CFR Part 11 e-signatures, and archive with a complete audit trail.
We didn't adapt generic software for GxP. We designed Hai-Trust from first principles around how regulated validation actually works.
Every feature, every workflow, and every data model was designed with regulatory compliance as the starting point — not retrofitted on top.
Our AI understands GAMP categories, testability criteria, and what regulators look for — not just natural language patterns.
Every action creates an immutable audit log entry. When inspectors arrive, your documentation is complete, traceable, and defensible.
The organizations that win in regulated industries treat compliance as a competitive advantage — not a burden to manage at year end.
Supported Frameworks
We work with pharmaceutical, biotech, and medical device organizations. Tell us about your validation challenges and we'll show you exactly how Hai-Trust addresses them.