In this guide 6 sections
Make the vendor demonstrate four things: an audit trail you can read, role rights you can restrict, signatures tied to a stated meaning and records that lock after approval. Software only supports GMP practice. Your quality system decides what is compliant.
Start with the audit trail, and ask to see one
Have the vendor open a live record and change one value, then read together what the system stored about the user, the time and the reason. Both old and new values must appear. Slides do not count. Insist on the live screen.
Then try to break it. Can the system administrator delete a line, and can the trail be switched off for the dispensing module alone, without anyone else noticing? Does it also cover master data, such as a raw material specification or a bill of materials, or only batch entries?
A good trail reads like a ledger for the QA reviewer, not a database dump for a developer, and it should filter by batch number, user and date range. Test the filters yourself.
- Is the trail created by the system, never typed by a user?
- Does it record the reason for each change?
- Can anyone, including an administrator, edit or delete it?
- Does it cover specifications, recipes and user rights?
- Can a reviewer filter it by batch and user?
Role rights decide who can touch what
List your real roles before the meeting: dispensing weigher, granulation operator, shift supervisor, QC analyst, QA reviewer, batch releaser and system administrator. Have the vendor log in as three.
The point is separation of duties. The QC analyst who enters an assay result must not approve it, and the administrator who creates user accounts must not be able to release a batch. Check that the system enforces this. A warning is not enough.
Ask about leavers too. Accounts should be disabled, never deleted, and old entries must keep their author, or the batch history loses its owner when an inspector asks who dispensed a lot.
Signatures need a meaning, not just a click
A signature in a batch record says something specific: weighed by, verified by, reviewed by or approved for release, and the printout must show that meaning beside the name. Check for date and time as well.
How is a signature made? Does it demand the user’s own password again at that moment, or does a single click on a tablet at the line suffice? Shared logins ruin every answer.
Check what happens to a signature when the record changes afterwards, because the signature should be invalidated or the change blocked.
- Name, date, time and meaning shown on the record
- Re-entry of credentials at signing
- One person, one login, enforced
- Signature cleared or change blocked on later edits
Record locking and what happens after approval
Once QA approves a batch, the record should stop being editable, and a late correction should arrive as an addendum with its own reason and signature. Never accept a quiet edit.
Ask the vendor to pull up a record from two years back, with its trail, and export it as a PDF or CSV. Locked but unreadable is useless.
Ask where the server sits and who holds the backups, and request a restore test on a copy of your own data rather than a promise.
Ask for evidence, then write down what you were shown
Request the validation pack of requirement specifications, test scripts, executed results and known issues, then ask which parts you must repeat on your site and how long that takes.
Be clear about the limit. Software cannot make a plant compliant by itself, whatever the brochure says, because your SOPs, training and quality system carry that weight under your regulator’s guidance.
Print the questions in this article and take a pen to the demonstration, marking each answer as shown, partly shown or only said. Compare the sheets across vendors the same evening, while memory is fresh and the sales pitch has not yet blurred the details.
Vendor demonstration scorecard
Four blocks sit on a single page for audit trail, role rights, signatures and record locking, with questions running down the rows of every block. Three tick columns follow for shown live, shown on slides and only said, plus a notes column for the evidence you saw. The footer lists pack items and dates.
Open a blank worksheet to printQuestions owners ask
Can a vendor certify that their software is GMP compliant?
Not in any way that transfers. Compliance belongs to how your plant uses the system under your procedures, while a vendor can supply only validation evidence and features that support your practice.
Who should attend the demonstration?
Bring the QA head, a production supervisor, a lab analyst and whoever manages IT, because each will test a different part of the system. Each holds one scorecard.
Do we need all four features in the first release?
For batch and lab records, yes. Audit trail, rights, signatures and locking depend on each other, so a system lacking one weakens the other three as soon as an inspector reads the record.
How should we check a vendor’s claims afterwards?
Ask for a reference visit or a sandbox, run a short test batch with your own roles, and have QA read the trail before any commitment.