From Audit Anxiety
to Inspection Confidence
Clinplex is the compliance intelligence layer for pharmaceutical and biotech quality organizations. We analyze your quality records against FDA, ICH, EU GMP, and ISO requirements β surfacing gaps, prioritizing risks, and delivering audit-ready documentation across your entire product lifecycle.
Works With Your Systems. Or Works Standalone.
Whether you're running enterprise QMS platforms or managing quality with spreadsheets and shared drives, Clinplex delivers compliance intelligence where you are today β and scales with you as you grow.
Document Analysis
Upload SOPs, deviations, CAPAs, batch records, or any quality document. Get an instant gap analysis against the full regulatory framework. No integration required.
- Instant compliance gap detection
- Severity classification: Critical, Major, Minor
- Exact regulatory citations
- Specific remediation guidance
Perfect for: Paper-based QMS, early-stage biotechs, quick compliance checks, audit prep
Platform Integration
Connect Clinplex to your QMS, LIMS, or document management system for continuous monitoring. Gaps surfaced as documents are created or updated.
- Continuous compliance surveillance
- Real-time risk dashboard
- Systemic pattern detection
- Multi-site visibility
Integrations: TrackWise, Veeva Vault, MasterControl, ValGenesis, SAP
The Hidden Cost of Reactive Compliance
Your organization produces thousands of quality documents every year. Your QMS tracks them. Your team reviews them. But gaps still hide in plain sight β until an FDA inspector finds what your process missed.
Compliance Gaps Hidden Until Inspection
Manual reviews catch some issues. Systemic gaps across sites, products, and document types remain invisible until they become 483 observations.
Audit Prep = Fire Drill
Pre-inspection panic. War rooms assembled. Consultants engaged at $300/hour. Your quality team buried in document reviews instead of strategic risk management.
No Real-Time Risk Visibility
Multiple sites, complex portfolios, external CDMOs β yet no unified view of compliance risk. You learn about systemic issues after they've impacted multiple batches.
Pattern Detection Too Late
Recurring deviation themes, CAPA effectiveness failures, training gaps. Visible only after they've escalated into findings β never while correctable.
Continuous Compliance Intelligence
Clinplex acts as your compliance intelligence layer β continuously analyzing quality records against regulatory requirements, surfacing risks before they become findings.
What Clinplex Delivers
Our AI engine is trained on the complete regulatory corpus: FDA CFRs, ICH guidelines, EU GMP Annexes, ISO standards, GAMP frameworks. It maps your document content to specific requirements and flags where you fall short.
- Automated Regulatory Mapping: Every record analyzed against 21 CFR Parts 11, 210, 211, 820, ICH Q7-Q10, EU GMP, ISO 13485
- Severity-Based Classification: Gaps flagged as Critical, Major, Minor, or Observation with exact citations
- Targeted Remediation: Specific corrective steps β not generic advice, but the language your documents need
- Systemic Pattern Detection: Identifies recurring themes before they escalate
- Live Risk Dashboard: Real-time compliance posture by site, product, process, and record type
End-to-End Compliance Intelligence
From discovery through post-market surveillance, Clinplex provides compliance oversight at every stage of the regulated product lifecycle.
Discovery & Development
Method validation, process characterization, control strategies, design controls, tech transfer documentation.
CMC & Manufacturing
Process validation, batch records, equipment qualification, environmental monitoring, supplier quality.
Clinical Operations
Protocol deviations, IND/IDE submissions, site documentation, clinical batch records, GCP compliance.
Regulatory & Post-Market
Submission readiness, post-market surveillance, complaint handling, CAPA effectiveness, continuous improvement.
One Engine. Every Framework That Matters.
Ready to See What You're Missing?
Start with a single document or connect your entire quality system. Either way, you'll have compliance visibility you've never had before.