Assign product, testing, investigation and release decisions to accountable people.
| Role | Batches and products | Specifications and testing | Deviations and CAPA | Change controls | Equipment and suppliers | Release decisions |
|---|---|---|---|---|---|---|
| Admin | Edit | Edit | View | Edit | Edit | View |
| Production Manager | Edit | Edit | Edit | Edit | View | Edit |
| QC Analyst | View | Edit | View | View | — | Edit |
| QA Manager | View | View | Edit | Approve | View | Edit |
| Qualified Person | View | View | View | View | View | Approve |
| Equipment Coordinator | View | View | View | View | Edit | View |
| Supplier Manager | View | View | View | Edit | Edit | View |
Sets up users, reference data and access for the operating team.
Owns the batch record and follows its manufacturing status.
Starts on: Batches awaiting quality review
Records test outcomes and reviews the applicable product specification.
Starts on: Tests needing results
Investigates quality issues, owns corrective actions and reviews controlled changes.
Starts on: Change approval inbox
Makes the independent batch release decision after quality review.
Starts on: Batches awaiting quality review
Maintains calibration and qualification records for equipment used in production or testing.
Starts on: Equipment calibration attention
Maintains supplier qualification and assists with supplier changes.
Starts on: Supplier qualification review
Start free, then use Proto to change fields, steps and approvals before your team goes live.