A fixed rule sets each system's GAMP category and risk tier. Full depth where the risk is high, less paperwork where it isn't.
AI proposes answers to a short set of risk questions, and your team confirms them. A fixed rule then sets the GAMP category and risk tier, so the same answers always give the same result.
AI-native: AI drafts in your templates, from your sources. Your experts review instead of retyping, and a named person approves every decision.
It drafts validation plans, URS, risk assessments, IQ/OQ/PQ, trace matrices and reports, each section with its source and rationale. It never sets the risk tier, approves or signs.
Each requirement links to its risk, tests, evidence and approver. When someone asks why, the answer is one click away.
Each requirement links to its risk rating, tests, evidence, approvals and change history, with every edit in a time-stamped audit trail. The next change starts from there.
AI flags gaps before your reviewer sees a draft. High-risk systems keep full depth. Your QA team signs off on every decision.
AI flags gaps in completeness, consistency and traceability before review. A named reviewer approves every decision with a Part 11 e-signature. You can work without AI at any time.
Run Klariflow on your own GxP systems. AI drafts the deliverables; your team reviews and signs them. You help shape what we build next.
Describe the system and its intended use.
AI proposes answers. A fixed rule sets the tier. A person confirms.
AI drafts in your template and flags sections to review.
Your team edits and signs. Every change is recorded.
Requirement, risk, test, evidence and approver stay linked.
A vendor patch lands on Thursday. By Monday, someone has to decide which tests to re-run, and why.
Risk-based validation software for your GxP systems.
AI proposes the risk answers. A fixed rule sets the GAMP category and risk tier. Anything uncertain goes to a person.
Risk tier set by rule, with the reasoning shown
Validation plans, URS, risk assessments, IQ/OQ/PQ and reports, drafted in your templates. Every section shows its source.
Draft in your template, low-confidence sections flagged
AI flags gaps before review. Your reviewer approves with a Part 11 e-signature.
Review findings, then approval and signature
Every requirement links to its risk, tests, evidence and approver. It builds as you work.
One requirement, linked end to end
Every change is recorded: who made it, when and why. Including every edit to an AI draft.
What the AI proposed, what changed, who approved
Test cases mapped to each requirement, with evidence and results linked back.
Test case linked to its requirement and evidence
See which requirements and tests a vendor release touches before you decide what to re-test.
A change linked to the requirements it affects
Co-founder and CTO
Co-founder and Chief Compliance and Quality Officer
Co-founder and CEO
No. AI drafts and proposes. A fixed rule sets the risk tier. Nothing becomes a record until a named person approves it with an e-signature.
No. CSA is FDA guidance, not a mandate. Klariflow supports full computerized system validation (CSV), with effort sized to the risk and the reasoning recorded. Our written CSA position is next.
We build and release Klariflow under GAMP 5. Our supplier audit pack is available under NDA, and a per-release validation accelerator pack is in preparation.
No. Klariflow works alongside your quality management system.
No. Your data is never used to train any model. Klarixa does not log prompts or outputs, and the model version is pinned for each release.
Just takes 45 minutes.
We'll email you within one business day to arrange a short call, then the 45-minute session.
While you wait, take the product tour →| Req | Risk | Test | Result | Approver |
|---|---|---|---|---|
| URS-041 | Medium | OQ-016 | Pass | QA Lead |
| URS-042 | High | OQ-017 | Pass | Val. Lead |
| URS-043 | High | PQ-004 | Running | - |
| Req | Test | Risk | Re-test? |
|---|---|---|---|
| URS-042 | OQ-017 | High | Re-test |
| URS-051 | OQ-022 | Medium | Re-test |
| URS-060 | IQ-003 | Low | No, reason recorded |
