Requirements checklist
What to ask for when choosing software for aPI manufacturers.
A checklist built from how aPI manufacturers work, to print or save as a PDF and bring to any supplier meeting.
What the software should cover
Tick each one that matters to your business.
- Route and stage master
- Batch manufacturing records
- Intermediate and final lot genealogy
- Deviations and change control
- Laboratory results
- Retest and expiry tracking
Roles that need their own access
Who logs in, and what each person may see or change.
- For production heads
- For operators
- For analysts
- For quality staff
Reports to ask for
Ask to see each one with your own sample data.
- Batches by stage and product
- Yield by stage across campaigns
- Open deviations by age and stage
- Intermediate lots and the final lots they fed
- Equipment use and cleaning between products
- Retest dates by lot
- Dispatch by customer with certificate numbers
Systems it may need to connect to
Note which ones you already run.
- Laboratory instruments by file import
- Barcode and label printers
- Weighing scales
- Accounting export
Questions for any vendor
Put these to every supplier you are comparing.
- What does a batch record contain?
- Can a reprocessed lot be shown in the genealogy?
- How does it handle campaign cleaning?
- Is it validated?
- Can we trace a customer complaint to the starting material?
- How are approvals recorded?
- How is the demonstration arranged?
- Can we export the batch data?
Where the work usually breaks today
Circle the ones you recognise. They set the order of the project.
- Intermediates lose their lineage
- Deviations sit in a separate file
- Campaign cleaning is poorly recorded
- Solvent recovery blurs lots
- Retest dates are managed by hand
Prefer to talk it through? See the aPI manufacturers page.