Clarix
Workflows

Complete Batch Lifecycle

End-to-end batch workflow from formula approval through PIC release and MBR export.

Complete Batch Lifecycle

This workflow covers the entire life of a batch in Clarix — from approving the formula and receiving inventory lots, through step execution and QA review, to PIC release and MBR export. Use this guide when onboarding staff or auditing your batch process end-to-end.

Process overview

Batch status transitions

Stage 1 — Formula approval

Role required: Formulator, QA Officer

  1. Navigate to Formulas and open the formula you intend to manufacture.
  2. Review all components, quantities, units of measure, and theoretical yield.
  3. If the formula is in Draft status, click Submit for Approval.
  4. A QA Officer reviews the formula. If approved, the formula status changes to Approved.
  5. Only Approved formulas can be used to create a new batch.

Note: Revisions to an approved formula require creating a new formula version. The previous version remains accessible for historical batches.

Stage 2 — Inventory lot receiving

Role required: Warehouse / Receiving Technician

  1. Navigate to Inventory → Receiving and create a new lot receipt for each raw material.
  2. Enter supplier, lot number, quantity, unit of measure, expiry date, and COA reference.
  3. New lots are placed in Quarantine automatically until QA releases them.
  4. QA reviews the COA and approves or rejects the lot (see Receiving to Production for the full quarantine flow).
  5. Released lots appear in the available inventory pool for batch assignment.

Stage 3 — Batch creation

Role required: Batch Technician, Supervisor

  1. Navigate to Batches → New Batch.
  2. Select the Approved formula and enter the batch number, target quantity, and scheduled date.
  3. Clarix pre-populates the component list from the formula.
  4. Assign released inventory lots to each component. Scan barcodes or select manually.
  5. Save to create the batch in Draft status.

Note: Lot assignment can be deferred until the step where the component is actually dispensed, if your SOP permits it.

Stage 4 — Step execution

Role required: Batch Technician (with witnessed steps as required by SOP)

  1. Open the batch and click Start Batch to move it to In Progress.
  2. Steps must be executed in sequence unless your formula marks a step as deferrable.
  3. For each step:
    • Complete all required fields (weights, observations, calculations).
    • Attach photos or worksheets where prompted.
    • Log the instrument or equipment used (Clarix checks calibration status — see Equipment Readiness).
    • If a witness is required, the witness must sign before the step can be marked complete.
  4. Any out-of-specification result can trigger a Deviation inline. The deviation is linked to the batch automatically.
  5. Once all steps are complete, click Mark Complete to move the batch to Completed and queue it for QA.

Stage 5 — QA review

Role required: QA Officer

  1. The QA Officer is notified when a batch enters Pending QA.
  2. Navigate to Batches → Pending QA and open the batch.
  3. Review all steps, recorded values, attachments, yield calculations, and open deviations.
  4. If a review-by-exception applies, document the rationale before approving.
  5. Click Approve to advance the batch to Awaiting PIC, or Return to send it back to the technician with comments.

Stage 6 — PIC release

Role required: PIC (Pharmacist-in-Charge)

  1. The PIC is notified when a batch enters Awaiting PIC.
  2. Review the QA-approved batch record, yield summary, and any exception notes.
  3. Click Release and apply the electronic PIC signature. The batch moves to Released.
  4. The MBR (Master Batch Record) PDF is generated and available for download under Batch → Exports.

Note: Electronic signatures in Clarix comply with 21 CFR Part 11 — each signature records the user, timestamp, and meaning of signature.

Edge cases

ScenarioHow Clarix handles it
Out-of-sequence step attemptedClarix blocks the step and displays an error. Steps must be completed in order unless marked deferrable.
Deferred stepDeferred steps can be completed later in the batch. They are flagged in the batch record for QA review.
GDP amendment after step completionUse the Amend action on the completed step. The original entry is preserved with a strikethrough; the amendment, reason, and signature are appended per GDP.
Review-by-exceptionQA documents a justification before approving a batch with open exceptions. The justification is included in the MBR.
Yield below thresholdAn alert is shown to the QA Officer during review. A deviation must be created or exception documented before the batch can be approved.

Workflows

End-to-end workflow guides for Clarix — from receiving raw materials through FDA inspection readiness.

Receiving Materials to Production

From supplier shipment through QA quarantine release and lot assignment in a batch step.

On this page

Complete Batch LifecycleProcess overviewBatch status transitionsStage 1 — Formula approvalStage 2 — Inventory lot receivingStage 3 — Batch creationStage 4 — Step executionStage 5 — QA reviewStage 6 — PIC releaseEdge casesRelated pages