Requirements checklist
What to ask for when choosing software for pharmaceutical manufacturers.
A checklist built from how pharmaceutical 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.
- Product, formula and specification master
- Supplier approval and material receipt
- Batch planning and manufacturing records
- Batch and lot traceability
- Quality checks and release
- Document control and change records
- Dispatch, returns and recalls
Roles that need their own access
Who logs in, and what each person may see or change.
- For owners and plant heads
- For purchase and warehouse teams
- For production and packing staff
- For quality assurance and control
- For sales and dispatch teams
Reports to ask for
Ask to see each one with your own sample data.
- Batches by status, product and room
- Material lots in quarantine, approved and rejected
- Supplier approval status and review dates
- Deviations and CAPA open and closed, by cause
- Stock by batch with days to expiry or retest
- Distributor shipments by batch
- Returns and complaints by product and batch
Systems it may need to connect to
Note which ones you already run.
- SMS
- WhatsApp or other messaging
- Label printer
- Laboratory instrument file import
- Accounting software export
Questions for any vendor
Put these to every supplier you are comparing.
- Can batch records be kept electronically?
- Is the system validated?
- Can a lot be traced to every batch and distributor?
- Can material be blocked until the laboratory result is in?
- Does it handle contract manufacturing for several brands?
- Can it connect to laboratory instruments?
- Can existing stock and suppliers be moved in?
- Can several plants use one system?
- Who owns the data?
- What does it cost?
Where the work usually breaks today
Circle the ones you recognise. They set the order of the project.
- Batch records live on paper
- Material status is hard to see
- Supplier approval is scattered
- Changes lack a clean trail
- Recalls need fast answers
Prefer to talk it through? See the pharmaceutical manufacturers page.