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Veeva RIM Regulatory Information Management

Veeva RIM + Opsima

Vault RIM manages regulatory submissions. Opsima captures the manufacturing data that supports them.

Vault RIM manages regulatory submissions. Opsima captures manufacturing observations and compliance events from production communication for Vault RIM.

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Real-time
Manufacturing data
Zero
New tools
3 days
Average time to go live
How it works

Three steps. No disruption.

STEP 01

Capture

Opsima monitors manufacturing communication for regulatory-relevant events.

STEP 02

Structure

AI classifies events relevant to regulatory documentation.

STEP 03

Connect

Structured data supports RIM regulatory information management.

Capabilities

What Opsima enables.

Manufacturing Data

Production events relevant to regulatory submissions are captured.

Quality Events

Quality events that may affect regulatory status are documented.

Change Documentation

Manufacturing changes relevant to registrations are captured.

Compliance Events

Compliance-relevant observations from manufacturing are documented.

Inspection Support

Manufacturing data supports regulatory inspection readiness.

Post-market Data

Manufacturing observations relevant to post-market surveillance.

Common use cases

  • Manufacturing data for regulatory submissions
  • Quality event documentation
  • Change documentation
  • Inspection readiness
  • Post-market surveillance support

Industries

Pharmaceutical Biotech Medical Devices
FAQ

Common questions about Veeva RIM.

Does Opsima replace Vault RIM?
No. Opsima provides manufacturing data that supports RIM workflows.
Does it support eCTD submissions?
Manufacturing data captured can support CMC sections of regulatory submissions.
How does change control work?
Manufacturing changes captured from field communication can feed RIM change impact assessments.
Does it work with Vault Quality Suite?
Yes. Data flows across Vault QMS and RIM modules.

See Veeva RIM + Opsima in action.

15 minutes on your actual data. No slides, no fluff.

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