Case study · Batch records
Batch records praised by inspectors: “clearer and closer to reality”
This large biologics site had complex records, with many errors and back-and-forth. After simplification, the early 2025 inspection gave positive feedback on the batch records.
The results
13records coached, then rolled out by the site
2025inspection with positive feedback on the batch records
3 pointspraised: clarity, shop-floor reality, critical parameters
more sitesthe roll-out will extend to other sites
The starting point
- A biologics production site of about 700 people.
- Complex batch records, with many errors and back-and-forth.
- Manufacturing and dosage-form records to simplify.
What we did together
- Analyse the recordEach data item screened with our C.O.B.R.A. tool (13 questions), and the structure compared with the actual sequence on the shop floor.
- We do it for youA first prototype built with the team, following our 11 ergonomic principles, then tested in production.
- You do it, we coachThe site’s teams design the following records, with our support at each step.
- Define who reviews whatTargeted review rules and direct corrections, to avoid back-and-forth.
- You roll it outThe site extends the approach to its other records, with regular support sessions.
What made the difference
“Clearer”
the batch records are easier for inspectors to read.
“Closer to reality”
they better reflect what happens on the shop floor.
“A plus”
the highlighting of critical parameters is noticed.
A roll-out that is expanding
the site is continuing, and other sites will follow.
Our takeaways
A record designed for the user isn’t less compliant: it is more so, because it clearly shows what matters. The inspectors pointed this out.
The approaches used
Our advice if you’re getting started
- Highlight critical parameters: they are what the operator, the reviewer and the inspector must see first.
- Model the record’s structure on the actual sequence on the shop floor.
Do your batch records always come back with corrections?
Let’s talk about your records: together we’ll analyse a typical record and what it costs you in review.