Safety — Risk Management & Compliance

Risk plans, the PSMF and periodic reports, run as one traceable process.

The QPPV, regulatory affairs and affiliates share one process, from RMP distribution and PSMF compilation to periodic report acknowledgement, instead of separate systems and trackers.

Verified proof point

Merck KGaA — PSMF: 3 weeks → minutes

Risk Management & Signal Detection

Distribute an RMP and track its implementation in the same place.

Risk Management Plans have to reach every affiliate and distributor, and implementation status has to come back. Traditionally that takes an external system for sharing content and a separate one for reporting status, backed by Excel trackers. CARA manages it end to end in a single cloud platform

RMP distribution: workflows send RMPs to affiliates and distributors, manually or by API call.
Managed documentation: internal creation, review and approval, plus documents for regulatory submissions.
RIM tracking: RMP activities tracked in the CARA RIM module.

Download the Risk Management datasheet

The PSMF is assembled, not authored from scratch each cycle.

A PSMF with many owners still compiles into one document.

Managing the PSMF is a complex, ongoing task. Sections are owned by different parts of the business, and the annexes are built from information held in a variety of sources. CARA brings it together into one submission-ready Word or PDF document, approved by the QPPV.

Owned sections: each chapter and annex has its own owner and can be reused elsewhere.
Generated annexes: submission-ready PDFs from Safety Data Exchange Agreements, Excel exports or direct integration.
Periodic review: quarterly and annual workflows notify section owners, with versioned updates.
Global and Local: local sections inherit properties from global ones, per country or market.

Download the PSMF datasheet

Safety Submissions & Distributions

Periodic reports reach affiliates and distributors, and acknowledgement comes back.

Distributing safety information is an ongoing, periodic task: it has to reach affiliates, distributors and other third parties, and every interaction has to be tracked. CARA saves time on each cycle by triggering distribution as a workflow.

Distribution workflows: safety data and documents reach affiliates and distributors, manually or from external partners.
Report documentation: creation, review and approval of PSURs/PBRERs, DSURs, educational materials and aggregate reports.
RIM integration: safety data and documents connect directly to RIM and regulatory documents.

Download the Safety Submissions & Distributions datasheet

Underneath Every Capability Above

CARA AI generates the PSMF from live safety data in minutes, and compares RMPs against SmPC and CCDS to catch misalignment before submission.

50–70%

reduction in PBRER and DSUR drafting time per cycle

0 %

Merck KGaA

PSMF generation: 3 weeks → minutes
Generated directly from the live, governed safety data already on the platform — no extraction, no cross-system reconciliation, while maintaining 21 CFR Part 11 compliance throughout.

Common Questions

Before you talk to a specialist, here's what most safety teams ask first.

Does CARA replace our existing safety system, or sit alongside it?

Both are valid. Some customers migrate case management, PSMF, and submissions fully onto CARA. Others keep an existing safety system in place and use CARA as the unified layer that connects it to Regulatory and Quality data. Which fits depends on where your integration and reconciliation cost is actually coming from today.

How is AI-generated content in the PSMF or a PSUR governed and verified?

Every AI output includes source trace links back to the record it was generated from, and every generation event is captured in the same audit trail that covers manual edits. CARA AI is configured not to fabricate data or fill gaps with invented content — where information isn’t available, it reports that rather than guessing.

Where does the data for RMPs, PSMF annexes, and PSURs actually come from?

Primarily from records already on the platform — Safety Data Exchange Agreements and case data, plus RIM records native to CARA. Where a source sits outside CARA, annexes can also be generated from Excel exports or a direct system integration, with the source and any change to it recorded automatically.

Does CARA AI run on data outside our governed environment?

No. AI processing happens inside your CARA environment under your existing user permissions, regardless of which underlying LLM is configured. Data doesn’t leave the platform to be processed, and there’s no cross-customer model training on your content.

Platform Connectivity

One governed safety record — connected to your reporting gateway, and to the rest of Safety.

The same governed record that submits to health authorities also stays coded against MedDRA and sourced from external systems when needed — and, when you're ready, connects to the wider Safety record it's part of. Nothing is exported to get there.