URS to PQ — one validation chain, fully traceable.
Built by life science experts to simplify validation management.
“Our last computer system validation took 40% less effort — the templates and traceability matrix paid for themselves on day one.”
Improved traceability & automation
Replace manual coordination with structured, configurable workflows — with a full audit trail on every action.
Confident compliance
Designed to support FDA 21 CFR Part 11, EU GMP Annex 11 and ISO 13485 — inspection-ready by default.
Data-driven oversight
Monitor activity, backlogs and compliance KPIs in real time so leadership has the visibility it needs.
Faster implementation
Go live in weeks — not quarters — with structured rollout, training and 24/7 support.
From day one — every step controlled.
Validation lifecycle execution
- Author URS, FS and DS from controlled templates
- Execute IQ, OQ, PQ with electronic test scripts
- Capture screenshots and evidence inline
- Auto-generate the traceability matrix
GAMP 5 categorisation
- Classify systems by GAMP category
- Right-size validation effort by risk
- Document supplier assessments
- Maintain validation status across the inventory
Periodic review & re-qualification
- Schedule periodic reviews automatically
- Re-qualify on configuration or version change
- Track re-validation status
- Maintain a single validation summary report
Inspection-ready evidence pack
- Assemble URS → PQ packs in one click
- Show signed test scripts with deviations
- Link defects to CAPAs and change controls
- Present a clean traceability story
Everything VLM ships with.
Reusable templates
Start from validated URS, IQ, OQ, PQ templates by system type.
Electronic test scripts
Execute scripts with pass/fail, evidence and e-signatures.
Traceability matrix
Auto-link URS → FS → DS → tests → defects → CAPAs.
Defect management
Track validation defects through investigation and closure.
Periodic review engine
Schedule, route and document re-qualification.
Validation summary report
Generate signed VSRs from validated content.
Designed to support the standards you’re audited against.
See VLM on your own data.
Bring a real scenario from your operations — we’ll show you exactly how Validation Management handles it.