Audit-ready compliance across the full drug lifecycle.
Clinplex maps your SOPs, quality records, and submission content to 21 CFR, EU GMP, and ICH—flags gaps with clause-cited evidence, guides remediation with regulatory templates, and verifies closure before inspections and submissions.
Most compliance work is still manual. Audits punish that.
Teams drown in SOPs, CAPAs, deviations, supplier evidence, and submission content. The gap isn’t “finding problems.” It’s closing them with proof—before the auditor asks.
Gaps surface late
Issues stay hidden until inspection prep, internal audits, or a warning letter forces the reveal. Manual reviews can’t keep pace with volume.
Fixes aren’t verifiable
Even when teams “update the SOP,” it’s unclear if the change actually satisfies the CFR clause. Auditors want evidence of closure—not intent.
Systems stay fragmented
QMS, EDMS, LIMS, supplier portals, and spreadsheets produce a partial view. Risk hides in the seams across documents and sites.
Submission readiness becomes chaos
“Submission excellence” depends on consistent, defensible quality evidence. Without a closure loop, teams rework the same gaps repeatedly.
Detect. Remediate. Verify. Export.
A compliance platform isn’t a score. It’s a closed loop that produces inspection artifacts.
Upload regulated documents
Start with SOPs and quality records today. Clinplex extracts sections, indexes evidence, and prepares clause-by-clause mapping.
- Upload-first wedge: SOPs, validation packages, CAPAs, deviations, supplier docs, submission sections
- Framework selection: 21 CFR, EU GMP, ICH + your internal standards
- Versioning: every analysis run is tied to a document version
| ID | SOP Section | Clause | Risk |
|---|---|---|---|
| GAP-001 | 7.1 Access & Security | 21 CFR 11.10(a)-(k), 11.300 | CRITICAL |
| GAP-002 | 9.3 Electronic Signatures | 21 CFR 11.50, 11.70, 11.100 | CRITICAL |
A compliance layer you can prove.
Start with document uploads today. Expand into integrated lifecycle coverage as Clinplex connects to your systems for continuous oversight.
What Clinplex Delivers
Clinplex turns regulated content into clause-cited findings, guided remediation, and verification artifacts that stand up in audits. It’s the difference between “we updated the SOP” and “we proved closure.”
- Clause-cited gap analysis: Findings mapped to 21 CFR, EU GMP, ICH with evidence snippets
- Guided mitigation: Template language tagged to clauses (Part 11, GMP, ICH) with tracked edits
- Verification re-scan: Before/after comparison that confirms gaps are truly closed
- Audit trail + versioning: Every change is attributable, reviewable, and exportable
- QMS-ready outputs: Findings register, CAPA-ready exports, and inspection packets
Designed for end-to-end readiness.
Clinplex supports paper-based teams today and is built to integrate across systems for full lifecycle oversight—through post-market and submission excellence.
Document-first deployment
Upload regulated documents and get clause-cited gaps, guided remediation, and verification artifacts without changing your stack.
- Validated gap register + severity
- Clause-tagged mitigation language
- Verification re-scan reports
- Export audit packs / QMS-ready outputs
Integrated lifecycle intelligence
Connect Clinplex to QMS/EDMS and quality systems to continuously evaluate records across sites, products, and workflows.
- Continuous gap detection across record types
- CAPA linkage and closure verification
- Cross-site pattern detection
- Submission readiness + inspection packet automation
Discovery & Preclinical
Method validation, early controls, documentation hygiene, tech transfer readiness.
Clinical Operations
Protocol deviations, site documentation quality, IND/IDE readiness, PV workflows.
CMC / Manufacturing
Validation, batch records, qualification, EM, supplier quality, GDP controls.
Post-Market / PV
Complaints, CAPA effectiveness, surveillance, continuous improvement signals.
Turn compliance into a verified system.
See how Clinplex produces clause-cited gaps, guided remediation language, and verification reports your auditors will accept.
Clinplex
Compliance Intelligence for Modern Life Sciences
Clinplex is an AI-powered compliance intelligence platform that connects to your existing QMS and data systems to surface regulatory gaps, strengthen CMC, and accelerate market entry. It’s built for emerging biotechs, commercial manufacturers, CDMOs, and device companies that want fewer surprises from regulators.
An Intelligence Layer on Top of Your QMS
Clinplex connects to your QMS, LIMS, ERP, and document repositories via secure APIs and continuously reviews your quality and CMC landscape against FDA, ICH, ISO, EMA, MHRA, and other global frameworks.
The Platform:
Classifies documents (SOPs, batch records, validation reports, change controls, submission sections)
Checks them against explicit, checkable regulatory and best-practice criteria
Scores issues by risk and impact
Recommends specific remediations with citations and suggested language
Tracks actions and outcomes with a full audit trail