From Reactive Fire Drills To Proactive Intelligence
Clinplex is the compliance intelligence layer that works with your existing QMS, transforming thousands of quality records into continuous, objective risk visibility—before FDA inspections reveal what you could have caught months earlier.
The Hidden Cost of Reactive Compliance
You've invested heavily in QMS, MES, and LIMS. Yet when inspections approach, teams still scramble through manual reviews, assemble war rooms, and discover gaps too late.
Compliance Gaps Hidden Until Inspection
Your teams produce thousands of SOPs, deviations, CAPAs, and batch records annually. Yet gaps remain invisible until FDA inspectors—not your quality team—uncover them. Manual reviews can't keep pace with documentation volume.
Reactive Fire Drills Drain Resources
Pre-inspection panic mode: data exports, consultant engagements, war rooms assembled. Quality teams spend countless hours on manual document reviews instead of strategic oversight and continuous improvement.
No Real-Time Risk Visibility
Multiple sites, complex product portfolios, external CDMOs—yet no unified, up-to-date view of quality risk. Systemic issues identified only after impacting multiple batches, never at the first warning sign.
Pattern Detection Too Late
Companies recognize recurring deviation themes, CAPA effectiveness issues, and systemic weaknesses only after adverse events or inspection findings—not while they're still minor and correctable.
Continuous Compliance Intelligence
Clinplex acts as your compliance intelligence layer—continuously evaluating quality records against FDA, ICH, EU GMP, and ISO standards. No more surprises. No more scrambling.
What Clinplex Does
Clinplex integrates with your existing QMS to continuously scan every quality record your teams create—SOPs, deviation reports, CAPAs, change controls, NCRs, batch manufacturing records, and training logs.
- Automated Regulatory Mapping: Every record analyzed against 21 CFR Parts 11, 210, 211, 820, ICH Q7-Q10, EU GMP, ISO 13485, and internal policies
- Severity-Based Gap Classification: Flags compliance issues as Critical, Major, Minor, or Observation with exact regulatory citations
- Targeted Remediation Guidance: Provides specific corrective steps for your team's review—no guesswork
- Systemic Pattern Detection: Identifies recurring themes across deviations, CAPA effectiveness, and change controls before they escalate
- Live Risk Dashboard: Real-time overview of compliance status by site, product, process, and record type
Oversight Across Every Product Stage
From R&D through commercial manufacturing and post-market surveillance—Clinplex provides continuous compliance intelligence throughout your entire regulated lifecycle.
R&D & Development
Method validation, process characterization, control strategies, design control files, tech transfer readiness, and scale-up documentation.
Clinical Operations
Protocol deviation reports, site documentation quality, IND/IDE packages, clinical trial batch records, and pharmacovigilance workflows.
Manufacturing & Distribution
Process validation, batch execution, equipment qualification, environmental monitoring, supplier quality, and GDP compliance.
Commercial & Post-Market
Process verification, post-market surveillance, complaint handling, CAPA effectiveness monitoring, and continuous improvement.
See Your Compliance Risk In Real Time
Transform your quality organization from reactive to proactive. Schedule a personalized platform demonstration.