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- ERP + Quality for Pharma
- Who it's for
- Injectable manufacturing
Injectable manufacturing
An injectable product can be recorded with its strength, dosage form and storage condition, while each manufactured lot carries its own dates, quantity and site. For a lot measured in Vials, Production Manager can record that unit directly on the batch. QC Analyst and QA Manager then follow the quality record for that same lot rather than relying on a product-level summary.
How ERP + Quality for Pharma is set up for you
Product context
Admin maintains the product code, name, dosage form, strength and storage condition.
Testing
QC Analyst records results against product specifications and the affected batch.
Equipment attention
Equipment Coordinator keeps calibration and qualification status visible for assets used in production or testing.
Exception handling
QA Manager links a deviation to the batch and, where applicable, the affected equipment.
Decision
Qualified Person records the release judgment, while the workflow records the release operation and receipt for an approved batch.
An injectable product can be recorded with its strength, dosage form and storage condition, while each manufactured lot carries its own dates, quantity and site. For a lot measured in Vials, Production Manager can record that unit directly on the batch. QC Analyst and QA Manager then follow the quality record for that same lot rather than relying on a product-level summary.
Begin with one injectable product, one specification and one batch. Record the batch number, site and line, then enter test outcomes. If equipment status is Overdue, review it in the equipment attention screen and reference that asset in any relevant deviation. Follow the investigation and corrective action before the quality review. Compare the batch, result, deviation, equipment and release decision in a single rehearsal.
Agree what evidence from laboratory or equipment service systems the team will reference during review. The app provides fields for result notes, equipment state and receipt evidence links. The organization decides how external evidence is collected and checked. Record the human release decision before marking the batch Approved, and keep it separate from the receipt that describes the performed posting.
Features to start with
Roles on the team
- Production Manager
- Owns the batch record and follows its manufacturing status.
- QC Analyst
- Records test outcomes and reviews the applicable product specification.
- Equipment Coordinator
- Maintains calibration and qualification records for equipment used in production or testing.
Set up ERP + Quality for Pharma your way.
Start free, then use Proto to change fields, steps and approvals before your team goes live.