AI for Quality, CMC & Regulatory Operations

The risk isn't in one framework. It's in the overlap.

The intelligence layer for regulated records. Clinplex reads across 150+ frameworks at once — surfacing the gaps, cross-framework risk and draft-ready fixes your siloed systems can't see.

Run an Inspection Stress Test → For regulators →
Team experience includes · life sciences, federal health & enterprise software
Live
⚡
Overlap found
2.4s · cross-framework scan
✓
CAPA auto-routed
QA Ops · due 7 days
If a regulator cites it, we see it · 150+ frameworks mapped
FDA 21 CFR 211ICH Q7EU GMP Annex 11ISO 13485ICH E6(R2)21 CFR Part 11MDSAPICH Q10eCTD v4.021 CFR 58ICH M4EU GVPUSP <1058> FDA 21 CFR 211ICH Q7EU GMP Annex 11ISO 13485ICH E6(R2)21 CFR Part 11MDSAPICH Q10eCTD v4.021 CFR 58ICH M4EU GVPUSP <1058>
§ The Category

Not another QMS.
The intelligence layer over it.

Eleven systems can each hold part of the evidence. The regulatory risk often sits in the relationship between them. Clinplex reads across that boundary.

Your records are already there. The intelligence isn’t.

The QMS contains the deviation. The LIMS contains the result. Validation contains the qualified state. Clinplex evaluates whether the combined evidence supports the same regulatory conclusion.

Clinplex is the AI regulatory intelligence layer that augments your QMS. The QMS is the system of record. Clinplex is the intelligence layer the QMS was never designed to provide.

⊕
Reads across, not by framework
150+ frameworks evaluated in parallel — overlaps surface instead of hiding in separate libraries.
↔
Read-only by default
Connects to Veeva Vault, MasterControl, TrackWise and ValGenesis. Never writes to your validated systems.
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Cascading, with an owner
Every finding carries its linked records, a citation, an owner and a due date — not four reports stitched together.
Integration model
Read-only
Intelligence Layer
Gap detection Predictive risk Audit ready
READ-ONLY BY DEFAULT
QMS ● supported
Quality Management
MasterControl · Veeva QualityDocs · TrackWise · Sparta
LIMS ● supported
Lab & Sample Records
LabWare · STARLIMS · LabVantage · Benchling
VALIDATION ● supported
CSV & Process Validation
ValGenesis · Kneat · Veeva Validation Mgmt
+ eCTD · SAP · SharePoint · Veeva RIM
One cascading view.
§ Four Pillars · Molecule to Market

What that intelligence
actually does.

Four capabilities across the full product lifecycle — molecule to market.

01 · CONTINUOUS

Continuous gap detection

Reads SOPs, batch records, OOS results and eCTD modules — and flags drift the moment it appears, not at the next audit.

  • Cross-framework scan in seconds
  • Citations to specific clauses
  • Change-aware re-scoring
02 · PREDICTIVE

Predictive risk modeling

Patterns across sites, products and time point to where the next 483 or CRL is most likely to land.

  • Site & product heatmaps
  • Deviation → systemic CAPA signals
  • 483-likelihood scoring
03 · OPERATIVE

Operational intelligence

Cascades findings across systems and routes ownership and escalation — one queue for Quality, RA and Validation.

  • Auto-routing & ownership
  • Cross-system traceability
  • One queue, four functions
04 · AUDIT

Audit readiness, on demand

Every detection and closure timestamped under Part 11 — inspection-ready dossiers assemble as a byproduct of daily work.

  • 21 CFR Part 11 audit trails
  • FDA / EMA / MDSAP packages
  • Zero-assembly evidence
i · Discovery
Preclinical & GLP
21 CFR 58 · ICH M3
ii · Clinical
GCP & IND/CTA
ICH E6 · 21 CFR 312
iii · CMC
Manufacturing & Quality
21 CFR 211 · ICH Q7
iv · Submission
eCTD & Approval
ICH M4 · eCTD v4.0
All four pillars · across the entire lifecycle · molecule to market
§ Two Sides of the Inspection

Same intelligence.
Both sides of the table.

The overlap that creates regulatory exposure for a sponsor is the same evidence a reviewer must evaluate. One engine reads it — for whoever is holding the file.

For industry

Find the 483 before the inspector does.

Quality, regulatory and validation teams surface exposure across their own records — and close it before an audit ever opens.

Sponsors QA / RA CMOs & CROs Med device
01
Pre-inspection gap scan
Reads across QMS, LIMS and validation to surface the overlap an inspector would flag.
02
CAPA drafted and routed
Every finding arrives with a citation, an owner and a due date — not four reports to reconcile.
03
Always inspection-ready
Part 11 dossiers for FDA, EMA, MDSAP and ISO assemble as a byproduct of daily work.
For regulators & reviewers

Assess a submission's exposure in hours, not weeks.

Agencies, notified bodies and auditors read a filing across every framework it answers to — consistently, with the receipts attached.

Agencies Notified bodies Inspectors Auditors
01
Overlap across the full filing
Cross-framework gaps surface in one pass — no toggling between eleven separate libraries.
02
Consistent, defensible scoring
Every reviewer sees the same ranked risk, so judgment calls start from a shared baseline.
03
Every finding carries its source
Each flag links to the governing clause and the exact record behind it.
§ Document Generation

The finding arrives
with the fix attached.

Clinplex drafts inspection-ready quality and regulatory documents — mapped to the standards that govern each one, in minutes instead of days.

i
An expert author for every phase
A preclinical lead drafts the GLP protocol; a CMC reviewer drafts the validation summary; a PV scientist drafts the PSUR. Each of the eight lifecycle phases writes in its own regulatory voice.
ii
Two passes: write, then self-critique
A first pass drafts the document. A second pass reviews it against the governing standards and tightens the weak sections before it ever reaches you.
iii
Mapped to the standard, not generic boilerplate
Every section is generated against the framework that governs it — 21 CFR 211, ICH Q7, GAMP 5, ISO 13485 — in the structure an inspector expects to see.
49 document types, including
SOPsIQ / OQ / PQ protocolsCAPA recordsDeviation reportsMethod validationCTD Module 2.5 / 2.7PSUR / PBRERRisk management plans
Computer System Validation Protocol Quality · GMP
✓ Drafted & self-reviewed
21 CFR Part 11GAMP 5ICH Q9
1 · Purpose & Scope
2 · System Description & Risk Assessment
3 · Qualification Approach — IQ / OQ / PQ
4 · Acceptance Criteria & Traceability
● Pass 2 of 2 · refined Copy · Export .txt · Send to review
§ The Proof

What changes when overlap
becomes visible.

Validated across 1,035 regulated documents against SME-panel review — presented at the DIA 2026 Global Annual Meeting.

96%

Gap-detection accuracy

Measured against SME-panel ground truth.

3.0×

More gaps surfaced

12.3 gaps per SOP vs 4.1 under single-framework review.

73%

Less assessment time

Reduction in cross-framework assessment time.

98%

Critical-tier concordance

Agreement with SME review on Critical findings.

2.4s document scan · 150+ frameworks mapped · timestamped evidence trail
"
Your next 483 is already in your QMS. The question is whether you see it before the inspector does.
— The Clinplex thesis
View the validation methodology →

See it on your
own document.

Upload a protocol, SOP, batch record or eCTD module. Get ranked gaps with citations, an AI-drafted remediation, and an exportable report. Free.

Run an Inspection Stress Test → For regulators →