Your QMS is the system of record. Clinplex is the layer that reads across it.
Veeva Vault, MasterControl and platforms like them are systems of record: they hold, route and control your regulated documents, and they do that well. Clinplex does not replace any of it. It sits above the systems of record — including more than one at once — and evaluates what they hold as a single body of regulatory evidence.
What your QMS does. What Clinplex adds on top.
Each row is a capability boundary, not a criticism. A system of record manages documents inside its own walls; the gaps that draw inspection findings tend to live in the seams between systems — the deviation in one, the CAPA in another, the SOP in a third.
| Capability | What your QMS does | What Clinplex adds on top |
|---|---|---|
| Document control | Versioning, routing, approvals, periodic review — the controlled lifecycle of each document. | Nothing. Clinplex never writes to it; documents stay controlled exactly where they are. |
| Cross-record evaluation | Workflows link records administratively; content is reviewed by humans, 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. A regulator-divergence view — where FDA and EU expectations read the same record differently — is in development. |
| 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, so preparation is a standing state instead of an end-game project. |
Why a separate layer at all?
Because the evidence is separated. A gap-finder scoped to one vault only sees that vault's records; the inconsistencies that matter most sit between a QMS, a LIMS and a validation system that don't read each other's content. A layer that is independent of any one system of record can read all of them — and can be benchmarked independently, which is why the evaluation methodology is public. If your vendors converge on cross-system content intelligence someday, that's good for the industry; today, this layer is what closes the seam.
When Clinplex is the wrong fit
- You need a system of record. Clinplex doesn't store, route or approve controlled documents — buy a QMS for that.
- Your records live in one system, on one framework, in low volume. A capable reviewer covers that without a layer above it.
- You want AI to make compliance decisions. Clinplex output is advisory by design; a human sets final status, always.
- You process PHI. Clinplex does not offer a BAA — see Security and trust.
The cheapest way to test the seam.
Send a closed deviation, its CAPA and the governing SOP — three records your QMS already holds. Mutual NDA goes out the same day; findings come back within 48 hours.
Run a 3-record Inspection Stress Test