Questions, answered

Click Get started, then use Proto to configure ERP + Quality for Pharma for your business. Begin with one product, its specification and a representative batch.

The batch has a Product reference and its own batch number, quantity, dates, line, site and lifecycle status.

Quality specifications holds the product, test parameter, acceptance criteria, limits, effective date and version label.

QC Analyst enters a test results record for the batch with the observed value or text, outcome and analyst note.

QA Manager can open a deviation against the batch, record the investigation and link corrective action to it.

The action record holds the plan, owner name, due date, completion date and effectiveness check result. QA Manager reviews its status during batch quality review.

Equipment records show calibration status, last calibration date, next due date and qualification status. The Quality Exceptions & CAPA page also brings out-of-calibration equipment into view.

A change controls record can reference a supplier and carries the impact assessment, filing requirement and approval status.

Qualified Person records the independent release decision with its review stage, decision, reviewer and rationale. QA Manager marks the reviewed batch Approved only after a Release decision; the workflow posts every Approved batch.

Operation receipts records the performed batch release operation, its date, outcome, detail and evidence link. Review it with the batch and human decision.