CSV, end to end,with the effort where the risk is.
IQ, OQ, and PQ for a browser-based GxP system, from approved URS to signed report. Merivane generates and executes the protocols. Your team reviews, takes over, and approves.
- Approved requirement
- Test scripts
- Autonomous execution
- You take over
- Defects logged
- Signed OQ / PQ report
One chain. Three protocols.
IQ checks the installation. OQ proves the functions against the FRS, run autonomously. PQ proves the process against the URS, with people in the loop.
- Risk-based depthTest depth follows GAMP 5 risk categories.
- Each protocol is its own runIQ, OQ, and PQ each produce their own report.
- PQ steps are often manualTakeover is designed for process steps a person performs.
The documents an auditor asks for, produced by the run.
Your validation plan stays as it is. Merivane produces and, where marked, proposes the artefacts under it.
- Your VMP and templates stayMerivane produces the protocol-level artefacts under them.
- Nothing issues without a signatureEvery document needs your approval to become final.
- All documents export as PDFReady for the audit file.
Periodic review stops being a project.
Re-run the OQ on demand and compare it with the last run. Every past run stays available.
- Re-run the OQ on demandNo need to re-plan the protocol from scratch.
- Compare two runs side by sideDifferences are listed, not searched for.
- All past runs retainedThe full run history stays available to an auditor.
0 differences found.
Any browser-based GxP system you can give a test account to.
Where CSV fits with risk-based testing.
Questions about computer system validation.
If your question is not here, ask us. We reply within one working day.
Does it replace our validation master plan?
No. Your VMP stays. Merivane produces the protocol-level artefacts under it.
Does it do IQ?
Configuration and installation checks in the browser UI.
What about systems without a browser UI?
Not in scope today.
Can we keep our own document templates?
Your templates stay in use for the artefacts Merivane produces.
See a full run on one of your systems.
Bring one approved requirement. We show you the chain end to end, on a system you already use, in under an hour.
Book a demo