© Copyright 2002-2026, Generis Enterprise Technology Limited, all rights reserved
CARA is not a standalone PV tool. Case management, risk plans, PSMF, and safety submissions live on the same governed record as your Regulatory and Quality data — no exports, no reconciliation.
Explore Safety
One Safety deployment. Connected capabilities not separate systems to license and stitch together.
Every action, every output, every change, captured automatically.
One data model across case management, risk plans, and submissions means no conflicting versions, no manual reconciliation.
Controlled lifecycles, version management, and access controls are built into every safety workflow.
Customer story
"The single information lake ensures that data is entered only once and re-used, which then has the major benefit of being able to use that data for traceability and impact analysis across the process."
Customer story
Merck KGaA
Merck KGaA generates its PSMF directly from live, governed safety data already on the platform — no extraction, no cross-system reconciliation.
PSMF improvement
Compilation time
Unified Intelligence for Safety
CARA AI drafts PSURs, PBRERs, and DSURs, generates the PSMF directly from live governed data, and checks label/RMP/CCDS alignment before submission — inside your governance framework, not around it.
reduction in PSMF and PSUR/PBRER/DSUR drafting time per cycle
Common Questions
One governed record. Case management, risk plans, the PSMF, and safety submissions all share the same data model — so a case’s MedDRA coding, the RMP it’s linked to, and the PSUR it feeds into are the same record viewed differently, not separate exports reconciled by hand.
Both migration and coexistence are valid. Some customers move case management, PSMF, and submissions fully onto CARA. Others keep an existing safety system in place and use CARA as the unified layer connecting it to Regulatory and Quality data.
No — each function is a complete, dedicated capability. Case management covers structured and unstructured intake through E2B R3 output; the PSMF is compartmentalised and auto-compiled; submissions track to acknowledgement in every market. They share one data model because that’s what removes the reconciliation work between them, not because any one is a shortened version of a bigger tool.
Platform Connectivity
© Copyright 2002-2026, Generis Enterprise Technology Limited, all rights reserved