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MasterControl Quality & Compliance

MasterControl + Opsima

MasterControl manages quality documents. Opsima captures quality events from the source.

Opsima captures quality deviations, CAPA events, and compliance observations from manufacturing communication and pushes structured records into MasterControl quality management.

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Real-time
Quality data 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 and quality communication.

STEP 02

Classify

AI classifies quality events per your MasterControl taxonomy.

STEP 03

Sync

Structured records push into MasterControl quality workflows.

Capabilities

What Opsima enables.

Deviation Capture

Quality deviations from production communication become records.

CAPA Support

Corrective actions from field communication feed CAPA workflows.

Document Control

Quality events trigger document review workflows when needed.

Training Events

Training observations from the floor are documented.

Audit Data

Quality data supports audit preparation and execution.

Supplier Quality

Incoming material quality events are captured.

Common use cases

  • Quality deviation capture
  • CAPA event documentation
  • Audit data preparation
  • Training observation logging
  • Supplier quality tracking

Industries

Pharmaceutical Medical Devices Biotech Manufacturing
FAQ

Common questions about MasterControl.

Does Opsima replace MasterControl?
No. Opsima feeds MasterControl with production quality data.
Does it support FDA compliance?
Yes. Audit-trailed data capture supports FDA 21 CFR requirements.
How does document control work?
Quality events can trigger MasterControl document review workflows.
Does it work with MasterControl Mx?
Yes. Both MasterControl Classic and Mx platforms are supported.

See MasterControl + Opsima in action.

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

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