Work orders scored, failure modes extracted, FMEAs built. GMP-ready without touching your validated systems. QMSR is live.
CFR 11 and ALCOA+ compliant data unification. Each record scored against 15+ validators. Gaps flagged before they reach your quality system.
Failure modes, causes, and effects extracted from work orders, CAPAs, deviations, and PM logs. Equipment grouped by class so one analysis covers every instance of that type.
Every engineer correction is stored and applied forward. Confirm a failure mode on Agitator 1, it carries to Agitator 47 without re-entry. No drift between sessions.
5,000 assets might be 200 equipment classes. Analyze one centrifugal pump type, the FMEA covers all instances. Corrections propagate to every unit in that class. No repeated work.
Functional locations, equipment classes, and failure taxonomies aligned across sites and systems. The hierarchy is a standalone deliverable your team keeps.
Deployed on your AWS/Azure tenant. Zero data egress. SOC 2 controls. Air-gapped mode available. Your data never leaves your environment.
Search across work orders, SOPs, and FMEAs in conversation. All answers cited to source. Edit FMEA cells inline. 34 languages, online or air-gapped.
Score every record for completeness and accuracy in real time. Track quality trends across teams, sites, and shifts. Alerts when quality drops below thresholds.
What one system reveals applies across every instance of that equipment class. No variation between analysts or sessions. Results are reproducible and auditable.
Pharmaceuticals reliability and quality teams managing validated equipment across production lines. Existing CMMS, CAPAs, deviations, and a mandate to close risk gaps before the next audit.
Existing work orders, CAPAs, deviations, and PM logs. We extract failure modes, group equipment by class, and build FMEAs that carry corrections across the fleet.
No operational history yet. We work from OEM manuals, qualification protocols, and process specs to build your risk baseline before first production.
Each phase has a deliverable and a go/no-go gate. We earn the next one.
Weeks 1-3
1 critical system or line. Draft FMEAs. Data quality scores. Risk ranking.
Gate
70-90% of rows pass engineer review → expand
Months 2-4
Roll out across equipment classes. What one line proved applies to the next. Integrate with validation and quality workflows.
Gate
Is the site seeing measurable impact on compliance readiness and risk coverage?
Months 5-12
New events update FMEAs. Corrections carry across equipment classes. Audit-ready documentation. Cross-site consistency.
Gate
Renew and expand to additional sites.
Bring one manual. We show you what yours missed. 30 minutes.
