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Veeva Vault QMS Quality Management

Veeva Vault QMS + Opsima

Vault QMS manages quality events. Opsima captures them from the production floor.

Opsima captures quality deviations, CAPA events, and compliance observations from manufacturing communication and pushes structured records into Veeva Vault QMS.

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Real-time
Quality event capture
Zero
Forms for operators
3 days
Average time to go live
How it works

Three steps. No disruption.

STEP 01

Capture

Opsima monitors production communication where quality events are discussed.

STEP 02

Classify

AI classifies events by type and severity per your quality taxonomy.

STEP 03

Sync

Structured records push into Vault QMS deviation and CAPA workflows.

Capabilities

What Opsima enables.

Deviation Capture

Quality deviations from production communication become Vault QMS records.

CAPA Support

Corrective and preventive actions from field communication are tracked.

Change Control

Process changes discussed in field communication feed change control workflows.

Audit Trail

Quality events have complete audit trail from field capture to Vault record.

Training Events

Training-related observations from the floor are documented.

Complaint Support

Production observations that relate to product complaints are linked.

Common use cases

  • Quality deviation capture
  • CAPA event documentation
  • Change control support
  • Audit trail generation
  • Complaint investigation support

Industries

Pharmaceutical Biotech Medical Devices
FAQ

Common questions about Veeva Vault QMS.

Does Opsima replace Vault QMS?
No. Opsima feeds Vault QMS with production floor quality data.
Does it support 21 CFR Part 11?
Yes. Audit-trailed data capture supports Part 11 requirements.
How does CAPA work?
Quality events captured from field communication can initiate Vault QMS CAPA workflows.
Does it support Veeva Vault RIM?
Yes. Quality data from Opsima can support both QMS and RIM modules.

See Veeva Vault QMS + Opsima in action.

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

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