In this guide 6 sections
Have the vendor show a closed batch from a year ago, with its deviations, changes and audit trail, on screen, within minutes. Then ask who can edit a signed entry and what is logged when they do. Features matter less than whether records stay attributable and retrievable.
Judge by data integrity, not the feature list
A demo shows screens. An auditor reads records. Frame every question around ALCOA+: is each entry attributable, legible, contemporaneous, original and accurate, and also complete, consistent, enduring and available?
Vendors will say yes to all of it. So ask them to prove each one on a live batch, not a slide.
Bring a real master batch manufacturing record from your intermediate stage, with its in-process checks. Ask them to configure it while you watch. Note every point where they say it can be arranged later. Those are the gaps you will pay to close after signing.
- Who made this entry, and when, to the second?
- Can an entry be overwritten, or only superseded?
- Is the time stamp from the server or a user’s PC?
- What happens when two users edit the same step?
Questions on the batch record and the COA
Check how a batch record is issued. Does it pull the approved master version only, with a version number printed on every page? A superseded master reaching the floor is a classic finding.
Ask how the system handles an in-process limit. If a reactor temperature or a pH reading falls outside range, does it block the next step, or merely colour a cell?
Then follow the COA. It should draw its results from the lab entries, not be typed again. Retyping is where transcription errors enter. Ask also whether an out of specification result opens an investigation automatically, and who is notified when it does.
Deviations and change control
Ask for a deviation raised mid-batch. Can the operator open it from the step that failed, and does it link to the batch, the equipment and the material lots involved?
Then ask about closure. Who approves the root cause, who approves the corrective action, and can the batch be released while the deviation stays open? The answer should be no.
Change control needs the same test. A change to a master record should create a new version, with the reason and approver attached, and leave the old one readable.
- Deviation numbering that never repeats
- Links from deviation to affected batches
- Impact assessment fields before approval
- Effective date of each changed master
- Training record check before a new version goes live
The audit trail and the customer audit
The audit trail should record who, what, when and why, including the old value and the new one. Ask whether it can be switched off by an administrator. If yes, ask what logs that.
Now test retrieval. A customer in another country audits you eighteen months after dispatch and asks for batch records, raw data and the related deviations for three lots.
Time the vendor. Can QA produce the full set in the room, in readable form, without calling IT? If it takes a day, the system fails the test that matters.
What to ask about the vendor and the exit
Ask where the data sits, who holds the backups and how often a restore is tested. Ask what happens to records if you stop paying. Data you cannot read in five years is not enduring.
Insist on an export in a plain format such as PDF with a linked data file, and test it on a pilot batch before signing.
Take your findings to the next vendor call as a scorecard, and score every vendor the same way. Keep the completed sheets, since they show why you chose one system over another when a regulator or customer asks.
Vendor question scorecard for batch record software
A one page scorecard. Rows are the questions grouped under batch record, COA, deviation, change control, audit trail and retrieval. Columns hold the vendor’s answer, whether it was shown live, the QA reviewer’s mark, and notes on gaps. The bottom line logs how long it took to retrieve three old batches.
Open a blank worksheet to printQuestions owners ask
Is a paper batch record still acceptable?
Paper can be acceptable when controlled well. The case for electronic records is retrieval speed, version control and fewer transcription steps, not that paper is forbidden.
Do we need to validate the software ourselves?
Usually yes. The vendor supplies documents, but your unit remains responsible for showing the system fits your processes. Ask what validation support comes with the purchase.
Can this connect to our lab instruments?
Sometimes. Ask which instruments and file types the vendor has connected before, and insist on seeing a working link rather than a promise.
Who should be in the demo?
QA, production, the lab and IT. Each will spot a different gap, and the QA head should hold the scorecard.