The risk isn't in one framework. It's in the overlap.
The intelligence layer for regulated records. Clinplex reads across 150+ frameworks at once — surfacing the gaps, cross-framework risk and draft-ready fixes your siloed systems can't see.
Not another QMS.
The intelligence layer over it.
Eleven systems can each hold part of the evidence. The regulatory risk often sits in the relationship between them. Clinplex reads across that boundary.
Your records are already there. The intelligence isn’t.
The QMS contains the deviation. The LIMS contains the result. Validation contains the qualified state. Clinplex evaluates whether the combined evidence supports the same regulatory conclusion.
Clinplex is the AI regulatory intelligence layer that augments your QMS. The QMS is the system of record. Clinplex is the intelligence layer the QMS was never designed to provide.
What that intelligence
actually does.
Four capabilities across the full product lifecycle — molecule to market.
Continuous gap detection
Reads SOPs, batch records, OOS results and eCTD modules — re-evaluating records as relevant evidence changes — not waiting for the next audit.
- Cross-framework scan
- Citations to specific clauses
- Change-aware re-scoring
Risk prioritization from enforcement patterns
Findings ranked against published enforcement history — 483 observations, warning letters, inspection outcomes — so attention goes where observations actually happen.
- Site & product heatmaps
- Deviation → systemic CAPA signals
- Enforcement-pattern ranking
Operational intelligence
Cascades findings across connected evidence and routes ownership and escalation inside Clinplex, while customer systems remain read-only.
- Clinplex workflow ownership
- Cross-system traceability
- One queue, every function
Audit readiness, on demand
Every detection, disposition and closure carries a timestamped, attributable evidence trail designed to support Part 11 controls — review-ready dossiers assemble as a byproduct of daily work.
- Part 11-supporting audit trail
- FDA / EMA / MDSAP packages
- Evidence assembled continuously
Beyond the SOP.
Labs, clinical operations, devices and suppliers.
The same intelligence reads lab records, clinical procedures, supplier files and published enforcement actions.
QC record review
Completed lab worksheets and reports reviewed against your approved templates and methods before they reach QA. Every finding is cited, and a qualified reviewer makes the call.
- 21 CFR 211.194 · 21 CFR 58
- USP and Ph. Eur. test methods
- Human review and sign-off
Clinical operations and GCP
Clinical procedures evaluated against ICH E6(R3) and 21 CFR 312, so sponsor-oversight gaps surface before an inspection does.
- ICH E6(R3) · 21 CFR 312
- Sponsor and CRO oversight
- Clinical QA
Medical device
Supplier submission packages and device QMS procedures evaluated against 21 CFR 820, ISO 13485 and your own customer requirements.
- 21 CFR 820 · ISO 13485
- PPAP submission packages
- Customer-specific requirements
Warning letters and 483s
Published FDA 483s and warning letters read against your own procedures, so you know whether the same observation could be made at your site.
- FDA 483s · warning letters
- Your procedures, read-only
- Inspection readiness
Supplier qualification
Supplier qualification, quality agreements and ongoing oversight records evaluated against 21 CFR 211, ICH Q7 and Q10 and EU GMP.
- 21 CFR 211 · ICH Q7 · ICH Q10
- EU GMP Chapters 5 and 7
- API and material suppliers
The same document.
Four regulators. Four readings.
Multi-region sponsors answer to FDA, EMA, MHRA and PMDA at once — and the same evidence may create different expectations or inspection risk across authorities. That requires jurisdiction-aware reasoning across the same evidence, not simply another place to store it.
Same intelligence.
Both sides of the table.
The overlap that creates regulatory exposure for a sponsor is the same evidence a reviewer must evaluate. One engine reads it — for whoever is holding the file.
Find the 483 before the inspector does.
Quality, laboratory, clinical, regulatory and supplier quality teams surface exposure across their own records — and close it before an audit ever opens.
Evaluate cross-framework regulatory exposure in hours, not weeks.
Clinplex gives agencies, notified bodies and auditors a consistent way to evaluate a filing against applicable requirements, with every finding tied to its governing source and underlying record.
A general LLM can read the document.
Clinplex knows what must hold together.
The model is one component. Around it sits the regulated system a chatbot doesn't have.
The foundation model can change. The governed regulatory system around it is the product.
What changes when overlap
becomes visible.
Evaluated on a 1,035-document regulated corpus, including a blinded, SME-reviewed 312-document subset — presented at the DIA 2026 Global Annual Meeting.
Gap-detection accuracy
Measured against SME-panel ground truth.
More gaps surfaced
12.3 gaps per SOP vs 4.1 under single-framework review.
Less assessment time
Reduction in cross-framework assessment time.
Critical-tier sensitivity
Critical findings detected relative to SME-panel ground truth.
See it on your
own records.
Send a closed deviation, its CAPA and the governing SOP. Mutual NDA goes out the same day; findings come back within 48 hours. Redacted records are fine. Free.