Case study · Batch records
Move to commercial production: from 10% to 81% of records right first time
This biologics site was moving from clinical to commercial batches, with records that almost always needed correcting. We simplified the production and quality control records, ahead of the move to an electronic record.
The results
0-10 % → 81 %of records right first time at the 1st review
100 %right first time at QA review
14batch records simplified10 in production, 4 in quality control
6quality control annexes simplified
The starting point
- A 50-person site moving from producing clinical batches to commercial batches.
- Only 0 to 10% of records right first time at the first review.
- Manufacturing, dosage-form and quality control records to rework.
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
Production
10 manufacturing and dosage-form records simplified.
Quality control
4 records and 6 annexes simplified.
100% at QA review
no more corrections requested at the final review.
Ready for electronic
the site is moving on to a “paper on glass” electronic batch record.
Our takeaways
Simplify before going paperless: a clear record, with no unnecessary data, is the best foundation for an electronic record.
The approaches used
Our advice if you’re getting started
- Simplify your records before going electronic, not after.
- Don’t forget quality control: its records and annexes also weigh on release.
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.