Find compliance gaps before the FDA finds them.
AI-powered compliance intelligence that analyzes your quality records—uploaded or integrated—against FDA, ICH, and EU GMP requirements. Continuously. Automatically.
Upload a document.
Or connect your QMS.
Same intelligence either way.
Your way in
Upload SOPs, batch records, deviations, and CAPAs directly—PDF, Word, Excel. Or connect Clinplex to Veeva Vault, MasterControl, TrackWise, or SAP QM for continuous monitoring. Start with one. Scale to both.
Regulatory-native AI
Every record evaluated against FDA CFRs, ICH guidelines, EU GMP, and ISO standards. Exact regulatory citations. Severity scoring. Root cause rigor assessment. Cross-record pattern detection on integrated sources.
Fix before they find
Prioritized gap reports with remediation roadmaps. For integrated customers: real-time risk dashboards, trend analysis, and predictive scoring based on actual 483 and warning letter data.
What changes when
you can see.
When compliance risk is visible and continuous—not periodic and manual—everything shifts.
Faster gap detection
Issues surfaced in hours, not the 3–6 months manual audits take.
Annual cost avoidance
Reduced consulting, fewer remediation campaigns, prevented warning letters.
Per document analysis
Upload an SOP and get a complete regulatory gap report in seconds.
From first inspection
to global operations.
Growth-stage biotech
Paper-based QMS, preparing for your first FDA inspection? Upload your SOPs and know exactly where you stand before the investigator walks in.
Mid-size pharma & CDMOs
Running MasterControl or TrackWise? Connect Clinplex for continuous monitoring and cross-site pattern detection your QMS can't do.
Enterprise operations
Multi-site, multi-platform, multi-regulatory. Clinplex unifies compliance visibility across Veeva, SAP, and everything in between.
International market entry
Entering the US or EU market? Gap-analyze your existing quality documentation against FDA or EMA requirements before you file.
Start with one document.
Scale to your entire operation.
Upload an SOP for a free compliance analysis. Or schedule a demo to see the full platform.