The compliance intelligence platform for life sciences.
Whether you run a $50M QMS or manage quality from spreadsheets—Clinplex gives you the same thing: continuous, AI-powered visibility into where your compliance risk actually sits.
Compliance gaps don't care what system you use. They hide in SOPs stored on SharePoint. In CAPAs tracked in Excel. In deviations buried inside Veeva. The format changes. The risk doesn't.
No platform—paper or digital—continuously analyzes quality records against the regulations that actually matter. Your QMS stores the deviation. Your spreadsheet logs the CAPA. Neither tells you that deviation shares a root cause with three other records across two sites, and that pattern maps to the FDA's top 483 observations this year.
Clinplex was built to close that gap. One platform that works however you work—uploaded documents or direct integration—and delivers the same regulatory intelligence either way.
One platform.
Two ways in.
Your quality infrastructure is unique. Clinplex meets you where you are—and grows with you.
Upload and analyze
No QMS? No problem. Upload SOPs, batch records, deviations, CAPAs directly. Clinplex analyzes them against live regulatory requirements and returns actionable gap reports.
- Paper-based or Excel quality systems
- Pre-first-inspection startups
- CDMOs and contract labs
- International companies entering US market
- Quick compliance checks on any document
Connect and monitor
Already running a QMS? Clinplex connects directly and continuously monitors every record as it's created or updated—adding the analysis your platform wasn't built to do.
- Veeva Vault, MasterControl, TrackWise, SAP QM
- Cross-platform pattern detection
- Real-time risk dashboards across sites
- Automated regulatory change tracking
- Continuous inspection readiness
What makes this different.
Regulatory-native AI
Purpose-built on 21 CFR, ICH guidelines, FDA guidance, and real enforcement data. Not generic NLP running compliance prompts—domain-specific intelligence that knows what investigators look for.
Works your way
Upload a single SOP or connect an enterprise QMS. Same regulatory intelligence, same depth of analysis. Start standalone, scale to integration—or use both simultaneously.
Gets smarter every day
Every SOP, deviation, and CAPA analyzed improves pattern detection and regulatory mapping. The intelligence compounds—a moat that grows with every customer.
Non-negotiables.
- 01
Built by operators
Founded by pharmaceutical quality leaders with 16+ years inside FDA-regulated operations. Every feature traces to a real compliance failure.
- 02
Outcomes, not features
Faster gap detection. Fewer 483s. Lower compliance overhead. If it doesn't move those numbers, we don't ship it.
- 03
Meet you where you are
Paper-based startup or multi-site enterprise—same intelligence, same depth. No forced platform migrations. No prerequisites.
- 04
Regulatory-grade security
Your compliance data is competitive advantage. Protected with the same rigor 21 CFR Part 11 demands.
Pharma quality leadership
Enterprise AI engineering
What Clinplex replaces —
and what it augments.
Clinplex AI is not a QMS. It's the intelligence layer your QMS was never built to provide.
Replaces
Manual document review
Quality teams spending 60% of their time reading SOPs line-by-line against regulatory requirements. AI does this in 2.4 seconds with exact citations.
Periodic mock audits
Point-in-time snapshots that are stale by the time the report is written. Continuous monitoring means every day is audit-ready.
Emergency consulting sprints
$300K–$500K engagements triggered by announced inspections. Clinplex surfaces gaps before you need to call a consultant.
Spreadsheet-based CAPA tracking
Excel logs that track whether a CAPA was opened and closed — but never evaluate whether the root cause analysis was scientifically sound.
Augments
Veeva Vault
Veeva manages document lifecycle — routing, approvals, versioning. Clinplex adds regulatory content analysis, investigation adequacy scoring, and compliance pattern detection via REST API.
MasterControl
MasterControl handles quality workflows and training. Clinplex adds continuous regulatory gap analysis and cross-record intelligence through RESTful API integration.
TrackWise & SAP QM
TrackWise and SAP manage quality events and deviations. Clinplex adds predictive inspection risk scoring and severity-scored gap reports with remediation guidance.
Paper-based QMS
No QMS at all? Upload PDFs, Word docs, and Excel files directly. Get the same regulatory intelligence without buying enterprise software first.
Start with one document.
Scale to your entire operation.
Upload an SOP for a free compliance analysis, or schedule a call to see the full platform.