Requirements checklist
What to ask for when choosing software for contract pharma manufacturers.
A checklist built from how contract pharma 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.
- Client and product masters
- Technology transfer and exhibit batches
- Master and batch manufacturing records
- Free-issue and plant-purchased materials
- Deviations and change control
- Batch release pack
- Tolling invoices and campaign costs
Roles that need their own access
Who logs in, and what each person may see or change.
- For plant heads
- For production supervisors and operators
- For quality assurance
- For client contacts
- For stores and finance
Reports to ask for
Ask to see each one with your own sample data.
- Batches by client, product and status
- Open deviations and change requests by client and age
- Free-issue active reconciliation per campaign
- Yield against theoretical by product and line
- Release pack turnaround at client review
- Compression, blister and filling line utilisation across campaigns
- Tolling invoices raised and unpaid
Systems it may need to connect to
Note which ones you already run.
- WhatsApp or other messaging
- Accounting export
- Barcode labels for lots and containers
- Balance and laboratory instrument export
- Client login for pack review
Questions for any vendor
Put these to every supplier you are comparing.
- Can the same line run products for different clients?
- How does it keep a client’s active ingredient apart?
- Does it write the master batch record for us?
- Can the client approve a deviation inside the system?
- What happens when a yield falls below limit?
- Can we track technology transfer separately from routine batches?
- Will invoices follow batch quantities?
- How do we bring in our existing records?
- How is a quotation for a plant like ours decided?
- Who maintains templates after go-live?
Where the work usually breaks today
Circle the ones you recognise. They set the order of the project.
- Client rules are scattered across emails
- Free-issue material is hard to separate
- Batch packs arrive incomplete at client review
- Deviations and changes follow no common path
- Campaign costs cannot be billed cleanly
Prefer to talk it through? See the contract pharma manufacturers page.