Release review

Step by step

1. Evidence check QA Manager

   QA Manager reviews the batch, product specification, test outcomes, deviations, CAPA, relevant changes and calibration state.

   • Collects the lot context
   • Updates Batches, Test results, Deviations, Capa actions, Change controls, Equipment

2. Release judgment Qualified Person

   Qualified Person records a release decision with the review stage, decision, date, reviewer, rationale and any conditions.

   • Preserves the human decision and rationale
   • Updates Release decisions, Batches
   ApprovalA person approves before the work moves on.

3. Quality approval QA Manager

   QA Manager marks a batch Approved only after a Release decision and completed evidence review; other dispositions stay outside Approved.

   • Records Approved or Quarantined status
   • Updates Batches
   ApprovalA person approves before the work moves on.

4. Posting QA Manager

   The workflow takes every Approved batch to Released and records a matching operation receipt.

   • Records release status and operation evidence
   • Updates Batches, Operation receipts

5. Receipt review QA Manager

   QA Manager compares the receipt's outcome and evidence link with the batch status and human decision.

   • Reconciles outcome, decision and lot
   • Updates Operation receipts, Release decisions, Batches

QA Manager

Performs quality review and receipt reconciliation.

Qualified Person

Records the independent release decision.

QC Analyst

Supplies test outcomes.

Production Manager

Maintains the batch context.