SOURCES WE MONITOR
FDA Warning Letters & Compliance Actions ↗
EMA Guidance & Regulatory Updates ↗
PMDA Regulatory Science & Safety Updates ↗
ICH Guidelines & Implementation Updates ↗
FDA Warning Letters & Compliance Actions ↗
EMA Guidance & Regulatory Updates ↗
PMDA Regulatory Science & Safety Updates ↗
ICH Guidelines & Implementation Updates ↗
§ Integrations
Works across the systems that already hold your evidence.
Clinplex sits above your QMS, LIMS and validation systems as a read-only intelligence layer. It connects to Veeva Vault, MasterControl, TrackWise and ValGenesis — and never writes to your validated systems.
Clinplex
Regulatory intelligence layer
READ-ONLY BY DEFAULT
QMS
Veeva QualityDocs · MasterControl · TrackWise · Sparta
LIMS
LabWare · STARLIMS · LabVantage · Benchling
Validation
ValGenesis · Kneat · Veeva Validation Mgmt
+ RIM · eCTD · SAP · SharePoint
§ Three Ways In
Start where your IT calendar allows.
01 · UPLOAD / WORKSPACE
No integration required
Drop documents into a secure workspace and analyze the same day. This is how an Inspection Stress Test runs.
02 · READ-ONLY INTEGRATION
Clinplex pulls the evidence
Connectors read the relevant regulated records from your systems. Nothing is ever written back.
03 · ENTERPRISE ORCHESTRATION
Ongoing cross-system intelligence
Continuous overlap detection across QMS, LIMS, validation and submission records — one queue, four functions.
"Do I need an IT project just to try Clinplex?"
No.
Start in upload mode — no connectors, no impact on your validated systems. Integrate later, if the findings earn it.
See it over your
own systems.
A working session on your stack — which records Clinplex reads, and what it finds in the overlap.