Run every validation project,
from plan to release.
Hai-Trust runs the whole project, not just the paperwork: plan and schedule the work and the people, write and AI-review every deliverable, execute and trace your tests, manage deviations and change, and release under 21 CFR Part 11 — with an audit trail behind every step.
Validation shouldn't live in forty Word files and a spreadsheet.
The usual way
- Deliverables drafted in Word, reviewed by email, versions lost between inboxes.
- Reviewers catching the same gaps by hand, document after document.
- The trace matrix rebuilt in a spreadsheet before every audit.
- A document library you can search by title — but not by what is written inside.
- No single view of which projects are slipping and who is carrying the work.
With Hai-Trust
- Every deliverable authored, reviewed, approved and versioned in one controlled system.
- AI reviews each document against the regulations and cites the clause behind every finding.
- Requirements trace to tests, executions and deviations as the work happens.
- Search finds the word inside every document, and opens it on the passage.
- A portfolio view that tells you what needs a decision today.
From the first plan to the signed release.
One system for the whole validation lifecycle — waterfall or agile, one system or a phased roll-out in waves.
A guided project set-up builds the deliverable plan, schedule and dependencies.
Write in a controlled editor or upload Word, PDF and Excel — start from your templates.
AI reviews each document against Part 11, Annex 11 and GAMP 5; people decide.
Test cases, executions with evidence, and deviations raised where they happen.
Requirements linked to tests and results, with gaps shown as they appear.
Readiness checks, Part 11 signatures and an audit-ready package.
A second reviewer who has read every regulation.
Hai-Trust reads your URS, plans, protocols and reports the way an experienced validation reviewer would — then shows its reasoning, so your team stays in charge.
The requirement does not say the audit trail is secure, computer-generated and time-stamped, or that it records who changed what and why. Operators could edit entries without trace.
Record user, date/time, old and new value and reason for every create, change and delete; entries cannot be altered or deleted by any user.
Cited, not guessed
Every finding names the regulation or guidance it comes from, so a reviewer can check it in seconds.
People decide
The AI suggests. Your reviewers accept, reject or edit — every decision is tracked on the record.
Across documents
Findings compare deliverables with each other — a test plan that no longer matches its URS is caught.
Find the word inside every document — not just in its title.
Most document systems search names and metadata. Hai-Trust searches the text itself: project documents, your controlled library and linked Veeva and Kneat documents, in one box.
- The passage, highlightedEach result shows where the words appear, so you know before you open it.
- Opens on the spotClick a result and the document opens scrolled to the passage — Word and PDF.
- Only what you may seeResults never cross from one organization into another.
Know what needs a decision today.
Across every project: which are at risk and why, critical deviations, overdue work, and deliverables nobody is carrying — in plain sentences, not a wall of charts.
- Risk, explained“2 critical deviations, 52 overdue tasks” — the reason, not just a red dot.
- Delivery and capacity togetherSee planned hours against the people available to do them.
- Plans that stay honestBaselines, dependencies and waves show where the date is really going.
The whole validation file, connected.
Capture requirements and assess the risk of each one, with the risk carried through to testing.
Requirement → test case → execution → deviation, with gaps shown before an auditor finds them.
Execute protocols step by step with evidence captured against each result.
Record deviations against failed results and manage changes with an impact assessment.
Signatures that carry the signer, date and time, and meaning — bound to the record.
Who did what, when and why — recorded automatically for every change.
Numbered SOPs and policies with Draft → Review → Effective lifecycles and review dates.
Assign training on new documents and see who is qualified before they need to be.
Bring documents in from Veeva Vault, Kneat and SharePoint, and link work to Jira.
Built for the people who sign for validation.
- One view of every project and what is at risk
- Consistent deliverables across sites and teams
- Audit-ready evidence, not a pre-audit scramble
- AI catches gaps before your reviewers do
- Traceability that builds itself as you test
- Plans, waves and dependencies that stay current
- Your templates and methods, reused on every job
- Each client kept strictly separate
- Clear status to share with the client at any time
The controls an inspector asks about, built in.
Hai-Trust is designed around the expectations of 21 CFR Part 11 and EU Annex 11 — so the system holding your validation evidence meets the same bar as the systems you validate.
Audit trail
Secure, computer-generated, time-stamped records of every create, change and delete.
21 CFR 11.10(e)Electronic signatures
Printed name, date and time, and the meaning of each signature, linked to the record.
21 CFR 11.50 · 11.70Role-based access
Permissions by role and by project, so people see and sign only what they should.
21 CFR 11.10(d) · (g)Version control
Every document version kept, compared and restorable, with a lifecycle state on each.
Annex 11 §10Separated by organization
Each organization's data is kept apart, with automated checks guarding every route.
Data integrityHuman decisions
AI assists; qualified people review, approve and sign. The record shows who decided.
GAMP 5 · risk-basedWhat teams ask us first.
Does the AI make validation decisions?
No. The AI reviews documents and suggests findings and wording, each with the clause it relies on. Your reviewers accept, reject or edit every suggestion, and approvals are signed by people. The record shows who decided what.
Can we use our existing documents and templates?
Yes. Upload Word, PDF and Excel files — including PDFs exported from Excel — and review them in place. Your organization's templates become the starting point for new deliverables, and documents can be brought in from Veeva Vault, Kneat and SharePoint.
Does it support 21 CFR Part 11 electronic signatures?
Yes. Signatures record the signer's printed name, the date and time, and the meaning of the signature, and are linked to the signed record. Every change is captured in the audit trail.
Waterfall, agile, or a phased roll-out?
All three. Projects can follow a waterfall or agile approach, and multi-site or multi-release programmes can be planned in waves, each with its own dates, deliverables and sign-off.
Is our data kept separate from other customers?
Yes. Every organization's projects, documents and search index are kept separate, and automated checks guard every route against data crossing between organizations.
How do we get started?
Book a demo. We'll walk through your current validation process, show Hai-Trust on a system like yours, and agree a plan for a first project.
See Hai-Trust on a system like yours.
A 30-minute walkthrough with our team, shaped around how you validate today.
- AI review of a sample deliverable, live
- Planning, testing and traceability end to end
- Signatures, audit trail and your compliance questions