Compliance intelligence
that works with your systems.
Built by pharmaceutical quality leaders with decades of FDA inspection experience. We solve the compliance visibility gap that no QMS, MES, or LIMS was designed to address.
Your systems aren't the problem.
The gap between them is.
Pharmaceutical and biotech companies invest heavily in quality infrastructure. Yet when inspections loom, teams still scramble with manual reviews, war rooms, and external consultants.
Hidden Compliance Gaps
Gaps remain invisible until internal audits or FDA inspections uncover them. Organizations identify systemic issues only after they've impacted multiple batches.
Reactive Quality Operations
Quality teams spend 60% of their time on manual document reviews and audit prep, leaving no bandwidth for strategic risk management.
No Real-Time Risk View
Despite sophisticated systems, there's no continuous, objective view of compliance risk. Data lives in silos across QMS, LIMS, and MES platforms.
Pattern Detection Failure
Recurring issues across deviations, CAPAs, and change controls go undetected until they escalate into major compliance events.
A compliance intelligence layer
for your existing systems
Clinplex integrates with your QMS, LIMS, and MES platforms to continuously evaluate quality records against regulatory requirements—automatically surfacing risks before they become findings.
Continuous Automated Analysis
As records are created or updated, Clinplex automatically scans for completeness, regulatory alignment, and rigor of root cause analyses and corrective actions.
- Maps content to FDA CFRs, ICH guidelines, EU GMP, ISO standards
- Flags compliance gaps by severity: Critical, Major, Minor, Observation
- Provides exact regulatory citations behind each finding
- Suggests targeted remediation steps for immediate action
Real-Time Risk Dashboard
Live compliance intelligence that gives quality leaders an unprecedented view of risk across the entire organization.
- Top compliance gaps by site, product, process, and record type
- Trend analysis across deviations, CAPAs, and change controls
- Quality trajectory tracking over time by business unit
- Predictive risk scoring based on 483 and warning letter patterns
End-to-end lifecycle oversight
From R&D through post-market surveillance, Clinplex provides continuous compliance monitoring at every stage of the regulated product lifecycle.
R&D & Development
Method validation documents, process characterization studies, control strategies, design control files, tech transfer readiness, and scale-up documentation.
Clinical Operations
Protocol deviation reports, site documentation quality, IND/IDE submission packages, clinical trial batch records, and pharmacovigilance workflows.
Manufacturing & Distribution
Process validation protocols, batch execution records, equipment qualification, environmental monitoring, supplier quality, and GDP compliance.
Commercial & Post-Market
Ongoing process verification, post-market surveillance, customer complaint handling, CAPA effectiveness monitoring, and continuous improvement documentation.
Three critical advantages
Real-Time Risk Visibility
Consolidated compliance "radar" across multiple sites, product lines, and external partners—without harmonizing or replacing existing systems.
Efficiency in Quality Oversight
Pre-screen records and spotlight highest-risk items automatically, freeing quality experts to focus where they're needed most.
Early Detection of Systemic Issues
Correlate data across all record types to identify emerging patterns, allowing you to fix root causes before they escalate.
Our operating principles
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01
Domain Expertise First
Built by pharmaceutical quality leaders who've managed hundreds of FDA inspections. Every feature is informed by real compliance challenges, not theoretical constructs.
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02
Integration, Not Replacement
Your quality team and existing systems work. We augment them with intelligence, not force you to abandon proven workflows for yet another platform.
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03
Measurable Outcomes
Accountable to results: faster gap detection, fewer inspection findings, reduced compliance overhead. If it doesn't move those metrics, we don't build it.
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04
Regulatory-Grade Security
Your compliance data is your competitive advantage. Security and data integrity maintained with the same rigor as 21 CFR Part 11 requires.
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05
Empowerment, Not Replacement
We're not replacing compliance professionals—we're empowering them to shift from reactive firefighting to proactive risk prevention.
See compliance intelligence in action
Schedule a conversation to explore how Clinplex integrates with your quality systems and delivers immediate visibility into compliance risk.