Global Inquiries

Start with one document.
Deploy the full loop.

Securely upload regulatory documentation for an AI-driven gap analysis. From detection through verified resolution—experience the Clinplex platform ecosystem.

01

Compliance Analysis

Receive a severity-scored gap report with automated CAPA generation, task assignment, and remediation priorities. No commitment required.

Initialize Analysis →
02

Platform Demo

Full lifecycle visibility: AI gap detection, automated workflows, escalation protocols, and Part 11 audit trails.

Request Access →
03

Partnerships

Strategic alignment for pharmaceutical and biotech enterprises. Early access to resolution workflows and preferred pricing tiers.

View Program →
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+1 (908) 342-4584
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Headquarters
Columbia, MD — USA
21 CFR Part 11 • SOC 2 Type II • HIPAA Compliant • AWS GovCloud
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Closed-Loop Compliance Intelligence
Not just gap analysis. Gap closure.
Clinplex reads regulated documents, maps every finding to the exact clause, guides remediation, and verifies closure with a re-scan—so you can walk into audits with evidence, not explanations.
Regulatory mapping engine
Clause-level citations
Severity grading
Audit artifacts
01 · INGEST
UPLOADS
Bring the record in
SOPs, CAPAs, deviations, batch records, supplier packages, submission modules.
Open details →
02 · MAP
CITATIONS
Pin to the exact clause
Every gap ties to CFR / EU GMP Annex / ICH guidance—traceable and reviewable.
Open details →
03 · MITIGATE
GUIDED
Guide remediation
Templated compliant language + control expectations. Track accepted vs custom edits.
Open details →
04 · VERIFY
RE-SCAN
Prove closure
Re-run analysis on v2 and generate verification evidence for the audit file.
Open details →

Select a step to see what “done” looks like.

This is where your differentiation lives: not finding gaps faster, but closing them with evidence.

  • Gap Register: structured, cited, owner + due date
  • Mitigation Guidance: clause-tagged templates + track changes
  • Verification Report: v1 vs v2 pass/fail evidence
📌
Gap Register
Exportable
A dated log of gaps with severity, citations, owner, due date, and status—built for audit files.
Preview sample →
🧩
Mitigation Guidance
Clause-tagged
Suggested compliant language and control expectations. Track accepted vs customized edits.
Preview sample →
✅
Verification Report
Before/After
Re-scan evidence showing which gaps closed, which remain, and what clauses now pass.
Preview sample →
How it works
Detect → guide remediation → verify closure.
Clinplex isn’t just a checker. It creates the artifacts you need to close gaps and prove it to auditors.
01
Ingest

Bring the record in

Start with uploads today. Move to API integrations with QMS/LIMS/MES when ready.

02
Map

Clause-level mapping

Gap findings tied to the exact CFR / Annex / ICH clause—no vague “needs improvement.”

03
Mitigate

Guided mitigation

Suggested language and controls. Track what was accepted vs customized.

04
Verify

Re-scan and confirm

Run the revised document again. Generate a remediation verification report for the audit file.

Immediate value without integrations

  • Upload SOPs, deviations, CAPAs, batch records, submissions, supplier packages
  • Instant gap analysis mapped to CFR / ICH / EU GMP / ISO
  • Severity grading + traceable citations
  • Exportable gap register and audit-ready evidence pack
Reality check: Upload is the fastest wedge. It proves value before IT lift.

Enterprise coverage across the full lifecycle

  • API-based ingestion from QMS/LIMS/MES/EDMS + data lakes
  • Continuous monitoring across sites, CDMOs, and product portfolios
  • Portfolio risk dashboards + systemic pattern detection
  • Closed-loop remediation workflows tied to your QMS change controls
North star: Always-on compliance intelligence—no “audit season.”
What you hand to an auditor
Audit artifacts, not just findings.
Inspectors want evidence of control: gap identified, mitigation implemented, verification performed.
📌

Gap Register

A structured log of gaps with severity, owner, due date, and exact regulatory citations.

Citation: clause-level Severity: critical/major/minor Export: PDF/CSV
🧩

Mitigation Guidance

Templated compliant language + control expectations. Track accepted vs customized edits.

Templates: clause-tagged Tracking: accepted vs custom Flags: new gaps
✅

Verification Report

Before/after scan results proving closure. Built for audit trail documentation.

Re-scan: v1 vs v2 Evidence: closure timestamps Ready: inspection file
About - Clinplex
About Clinplex

Compliance that closes the loop.
Detect. Remediate. Verify.

Clinplex helps regulated teams turn documents and quality records into clause-cited gap analysis, guided remediation language, and verification artifacts auditors accept. Start with document uploads today. Expand into integrated lifecycle intelligence as we connect to your systems.

What we ship today
What we’re building next
Upload-first wedge for SOPs & quality docs
Clause-cited gap registers
Guided mitigation templates
Verification re-scan reports
The Problem

Audits don’t fail you on effort.
They fail you on evidence.

QMS tools store records. They don’t prove closure. The hard part is building a defensible chain from requirement → gap → mitigation → verification. That’s where teams lose time, and where findings get written.

Findings happen in the seams

Gaps hide across SOPs, CAPAs, supplier evidence, and submission content. Manual review misses cross-document inconsistency.

Remediation isn’t guided

Teams get told “add Part 11 controls” with no clause-tagged, auditor-grade language to start from.

Closure isn’t verifiable

After edits, nobody re-checks clause-level requirements. You only learn what’s missing when an auditor asks.

Submission readiness becomes chaos

“Submission excellence” requires consistent quality evidence. Without a closure loop, teams rework the same gaps repeatedly.

Our Approach

Make compliance auditable by design.

Clinplex isn’t “an AI score.” It’s a verification workflow that produces the artifacts QA and auditors care about. Evidence-first. Clause-cited. Versioned. Exportable.

Platform Reality: what you get
Gap Register
Mitigation
Verification
Evidence-first workflow

Clause-cited gap analysis

Every finding is mapped to a specific CFR/ICH/EU GMP clause with rationale and evidence snippets—so your team can defend it, not debate it.

  • Critical/Major/Minor severity + impact domain
  • Normalized clause IDs for traceability
  • Export-ready findings register

Gap Register Preview

IDClauseStatus
GAP-001 21 CFR 11.10(a)-(k) CRITICAL
GAP-002 21 CFR 11.50 / 11.70 CRITICAL
Lifecycle

Built for end-to-end readiness.

Clinplex supports paper-based workflows now and is designed to integrate into QMS/EDMS and data systems for full lifecycle gap analysis, mitigation, and submission excellence readiness.

🔬

Discovery & Development

Validation, control strategies, tech transfer readiness, and documentation hygiene before scale-up.

🧪

Clinical Operations

Protocol deviations, IND/IDE packages, site documentation quality, and PV readiness artifacts.

⚙️

CMC / Manufacturing

Batch records, qualification, EM, supplier evidence, CAPA closure verification, inspection packets.

📊

Commercial & Post-Market

Complaints, trend detection, CAPA effectiveness, and continuous improvement proof.

Strategic Impact

What Clinplex changes.

🧾

Evidence you can defend

Clause-cited findings, versioned mitigation, and verification reports that stand up under inspection.

⚡

Time back for QA

Automate review scaffolding so experts focus on judgment and decisions, not scanning and formatting.

🧠

Pattern visibility earlier

Detect recurring themes across record types so issues get fixed when they’re still small.

How we build.

  • 01

    Evidence over opinions

    Findings must cite clauses and show supporting evidence. If it can’t be defended to an auditor, it doesn’t ship.

  • 02

    Closure is the product

    Gap detection is step one. The platform wins when remediation is guided and verification is provable.

  • 03

    Integration, not replacement

    We start with uploads to deliver value immediately. We integrate to reduce friction and make coverage continuous.

  • 04

    Regulatory-grade rigor

    Security, integrity, and traceability are built for Part 11 expectations: versioning, attribution, and audit trails.

  • 05

    Operators first

    Built for QA/RA/CMC teams who live in inspections, audits, and submissions—not for demo theater.

Want to see Clinplex on one of your SOPs?

We’ll show the gap register, mitigation language, and a verification report—on your content, with your frameworks.

Request Demo Contact Sales
Clinplex | Digitize your QMS with AI

Digitize your QMS with AI

Replace paper binders with an AI‑assisted eQMS that finds compliance gaps, predicts risk, and keeps you perpetually audit‑ready.

🔐 21 CFR Part 11 🛡️ ISO 13485 / ISO 14971 ☁️ SOC 2 / HIPAA
Deviations
CAPA
Audits
Docs
Training
Suppliers

AI Insight: “CAPA recurrence trending in Mixing Line 2. Recommend adding effectiveness checks and refreshing training for SOP‑QMS‑014.”

✅ Auto‑generated tasks and owners. Closed loop to completion.

From paper to AI‑ready eQMS

Stand up core modules fast, then layer predictive analytics and automation.

📄

Document Control

Versioning, training links, change control, read & understand, and audit trails.

🔁

eQMS Workflows

Deviations, CAPA, Complaints, Change Control, Supplier Quality, Audits.

🤖

Risk & AI Insights

AI flags compliance gaps, predicts risk, and recommends mitigations.

📊

Dashboards & KPIs

Cycle time, CAPA effectiveness, training status, and audit readiness—live.

🔌

Secure Data Pipelines

EMR/LIMS/eSource integrations with full traceability and Part 11 compliance.

🛡️

eSignatures & Validation

Part 11‑compliant eSignatures, validation packs, and CSV (GAMP 5).

How the closed‑loop works

☁️

Ingest

Securely ingest docs, records, logs (PDF, CSV, API) from legacy systems and paper scans.

🧠

Analyze

AI maps content to standards, finds gaps, and scores risk by process/line/site.

✅

Act

Auto‑create CAPA, Change, or Training tasks with owners, due dates, and effectiveness checks.

📈

Learn

Outcomes feed back to improve signals—reducing recurrence and audit findings over time.

Aligned to your frameworks

  • ✓ FDA 21 CFR Part 11/210/211/312/820
  • ✓ ISO 13485 / ISO 14971
  • ✓ GxP (GMP/GCP/GLP)
  • ✓ EU MDR / IVDR
  • ✓ HIPAA / HITRUST
  • ✓ SOC 2 Type II

Estimate your ROI

Quick, conservative calculator for time and cost savings from digitization & AI assistance.

Weekly savings
$—
Annual savings
$—
Hours saved / wk
—h

What’s included

  • ✓ Discovery, URS/FS/DS, and a phased rollout plan
  • ✓ Core modules: Docs, Training, Deviations, CAPA, Change Control, Audit
  • ✓ AI risk scoring mapped to ISO 13485, Part 11, MDR
  • ✓ Validation package (IQ/OQ/PQ) and CSV deliverables
  • ✓ Dashboards, KPIs, and effectiveness checks
  • ✓ Integrations: Veeva, MasterControl, ValGenesis, TrackWise, Jira, LIMS/EMR

Security by design

SSO (SAML/OIDC), RBAC, encryption in transit & at rest, and least‑privilege access.

Compliance ready

Audit trails, immutable logs, electronic signatures, and periodic reviews.

Data governance

Provenance, data lineage, and retention policies aligned with your QMS.

FAQ

1. How does the closed‑loop AI work?

We ingest QMS records (docs, deviations, CAPA, audits), learn your patterns, and surface predicted risks vs. standards (ISO 13485, Part 11, MDR). Recommendations generate tasks that feed back into CAPA and training—closing the loop.

2. Can you integrate with our existing tools?

Yes. We commonly integrate with Veeva, MasterControl, ValGenesis, TrackWise, Jira, Confluence, SharePoint, and LIMS/EMR systems via APIs or secure data agents.

3. What about validation?

We deliver validation documentation (URS/FS/DS, IQ/OQ/PQ, risk assessments) aligned with GAMP 5 and 21 CFR Part 11, plus periodic review templates.

4. Security & privacy?

SOC 2 and HIPAA‑aligned architecture, SSO (SAML/OIDC), role‑based access, encryption at rest and in transit, and detailed audit logs.

5. Implementation timeline?

MVP in 6–10 weeks for core modules; phased rollout for advanced AI and complex integrations.