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.
Six steps, in sequence.
Connect, read-only.
Records arrive by upload, secure export or scheduled read-only connectors. Nothing is written back. Your validated state does not change.
Scan the whole corpus, continuously.
Every record is mapped to the 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.
Findings, with the clause attached.
Each gap ties source evidence to the governing requirement, with impact, severity rationale and a proposed remediation.
Trace the cascade.
Clinplex follows 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. The workload view distributes open findings across owners and due dates, so output lands as assignable work.
The evidence dossier.
Findings, citations, severity rationale and resolution history assemble into an inspection-ready trail. Readiness becomes a standing state, not a pre-inspection project.
Your systems of record stay authoritative. Clinplex reads across them.
Veeva Vault, MasterControl and their peers hold, route and control regulated documents. The gaps that draw inspection findings sit in the seams between them: the deviation in one system, the CAPA in another, the SOP in a third.
| Capability | Your system of record | Clinplex |
|---|---|---|
| Document control | Versioning, routing, approvals, periodic review. | Untouched. Clinplex never writes to it. |
| Cross-record evaluation | Workflows link records administratively; content is reviewed one document at a time. | Reads the deviation, its CAPA and the governing SOP as one evidence chain, across systems, and flags where the content stops agreeing. |
| Regulatory mapping | Templates and checklists your team maintains. | A curated multi-framework mapping. Every finding cites the governing clause. |
| Risk ranking | Severity fields your reviewers fill in. | Ranking from published enforcement patterns (483s, warning letters, inspection outcomes) through a governed, reproducible policy layer. |
| Remediation | CAPA workflow: routing, ownership, due dates. | The drafted remediation itself, with the linked-record cascade scoped, ready to enter your CAPA workflow. |
| Inspection readiness | Audit trails and document retrieval when the inspection comes. | A continuous read of readiness across the whole record set. |
Start where your IT calendar allows.
No integration is required to begin. Connect when the findings earn it.
Secure workspace
Drop records into a secure workspace and analyze the same day. This is how an Inspection Stress Test runs.
Clinplex pulls the evidence
Connectors read regulated records from Veeva, MasterControl, TrackWise, ValGenesis and peers. Nothing is written back.
Continuous cross-system intelligence
Overlap detection across QMS, LIMS, validation and submission records. One queue, four functions.
What the layer is made of.
Gap intelligence
Records evaluated as evidence chains against every framework that applies, surfacing the gaps single-framework review misses.
Operational intelligence
Which evidence a finding affects and where remediation has downstream impact. A finding becomes scoped, assignable work.
Regulatory intelligence
A curated mapping of FDA, EMA, MHRA, PMDA, ICH and EU GMP requirements, and how guidance changes ripple into your document set.
Enforcement-based prioritization
Findings ranked by published enforcement history, so attention goes to the issues most relevant to regulatory exposure.
Advisory output. Accountable humans.
The framework library is curated by Clinplex and updated as guidance changes. The basis of a finding is always inspectable.
Model output is advisory. Final compliance, gap and CAPA decisions rest with named, qualified reviewers.
Assigned through a governed policy layer, not free-form model judgment, with a reviewable basis for each call.
Accuracy is measured against a blinded SME panel and published on the Evidence page. Part 11 controls and the validation documentation set are on the Trust page.
What it reads.
Document types
Lifecycle phases
See it on your own records.
Send a closed deviation, its CAPA and the governing SOP. Mutual NDA the same day; findings within 48 hours. Redacted records are fine.
Run a 3-record Inspection Stress Test