One layer that reads what your systems hold separately.
Your QMS, LIMS, validation and submission systems each hold part of the regulatory evidence. Clinplex reads across all of them — read-only — and returns clause-cited findings, ranked by enforcement risk, with the remediation drafted. Here is the whole sequence, on real product screens.
Six steps, in sequence.
Connect, read-only.
Records arrive by direct upload, secure export, or read-only connectors that pull from your systems on a schedule. Nothing is ever written back; your validated state is not changed by using Clinplex.
Scan the whole corpus, continuously.
Every record is mapped to the regulatory frameworks that govern it and evaluated in context — the SOP against its deviations, the CAPA against its commitments, the validation package against the process it validates. The dashboard shows compliance posture across the full document set, not one file at a time.
Findings, with the clause attached.
Each gap arrives with seven fields: source record, governing requirement, deficiency, linked-record impact, severity, rationale and drafted remediation.
Trace the cascade.
A gap in one record rarely stays in one record. Clinplex follows the links — the CAPAs, change controls and training records that cite the affected document — and shows the full blast radius before you change anything.
Remediation, drafted and owned.
Every finding carries a drafted remediation, and the workload view shows how open findings distribute across owners and due dates — so the output lands as assignable work, not a report to re-type.
The evidence dossier.
Findings, citations, severity rationale and resolution history assemble into an inspection-ready evidence trail. Because the layer runs continuously — not just before an inspection — readiness is a standing state you can show, at any inflection point of the program.
What the layer is made of.
Gap intelligence
Cross-record, multi-framework gap detection. Records are evaluated as evidence chains — a deviation with its CAPA and governing SOP — against every framework that applies, surfacing the gaps single-framework review misses.
Operational intelligence
The linked-record graph: which documents cite which, where a change cascades, which records an open finding touches. This is what turns a finding into scoped, assignable work.
Regulatory intelligence
A curated mapping of the frameworks themselves — FDA, EMA, MHRA, PMDA, ICH and EU GMP — and how guidance changes ripple into your document set.
Risk prioritization from enforcement patterns
Findings ranked against published enforcement history — 483 observations, warning letters, inspection outcomes — so attention goes where observations actually happen. Severity itself is set by a deterministic rules table.
How the intelligence is governed.
Outputs that feed regulated decisions need more than accuracy claims. This is the control structure around every finding.
What it reads.
Document types
49 document types across the regulated set. The evaluated corpus behind that number is documented on the Proof page.
Lifecycle phases
Four phases, with phase-aware framework mapping — the requirements applied to a record depend on where the program is.
On the bench, honestly labeled.
These are in development or research, not shipping. They're here because buyers should see where the layer is going — and hold us to the same claim discipline when they arrive.
See it on your own records.
Send a closed deviation, its CAPA and the governing SOP. Mutual NDA goes out the same day; findings come back within 48 hours. Redacted records are fine.
Run a 3-record Inspection Stress Test