1. ERP + Quality for Pharma
  2. Implementation
Reference

How a ERP + Quality for Pharma rollout works

Prepare a product, lot and quality review cycle before wider use.

  1. Reference setup

    Agree product codes, specifications, equipment and supplier records with the people who maintain them.

  2. Pilot lot

    Create a batch for one product with a clear number, quantity, line, site and dates.

  3. Quality rehearsal

    Record test outcomes, one investigated exception and a linked corrective action.

  4. Decision rehearsal

    Review the batch with QA Manager and Qualified Person, including a Hold case.

  5. Posting check

    Record the release decision, mark the reviewed batch Approved, then compare its Released status and operation receipt with that decision.

  6. Operating rhythm

    Assign owners for due CAPA, calibration, supplier audit and change approval views.

What the customer provides

Provide product and lot identifiers, acceptance criteria, current equipment calibration status, supplier qualification state and the people who own quality decisions. Bring a representative exception and one completed release case for rehearsal. Decide where laboratory, equipment service and document evidence will come from.

Changing it afterwards

Keep product and specification versions clear when requirements change. Review open batches before applying a new change. Preserve the decision, investigation and receipt history for completed lots, and use new records for new work rather than rewriting the evidence behind a past release.

Set up ERP + Quality for Pharma your way.

Start free, then use Proto to change fields, steps and approvals before your team goes live.

How to get started