Guides for quality and engineering teams
What we learned building a counting and inspection station for regulated production, written for the people who have to qualify one. No gated forms, no sales copy.
21 CFR Part 11 for vision systems: what to check before you buy
2026-09-167 min read
A camera system that produces GMP records falls under the same rules as every other computerised system on the floor. Here is what that means in practice, as a checklist you can take into a vendor meeting.
Read the guideCounting tablets: manual, weight-based or camera?
2026-09-168 min read
Three methods dominate quantity checks in pharmaceutical production. They fail in different ways, and the failure modes matter more than the headline accuracy.
Read the guideHow to validate a vision system: a practical path through GAMP 5
2026-09-169 min read
Validation is where vision projects stall, usually because the testing is written from the software's features instead of the process risk. This is the route that works, and the tests that actually prove something.
Read the guide
Take the checklist into your next vendor meeting.
Two pages: the technical controls to verify before you buy, the challenge tests that prove them in the OQ, and what to agree about the detection model. No form, no email required.
PDF · 2 pages · English
See the station itself
- Pharmaceutical vision systemCounting and damage inspection with GxP-grade evidence, from trigger to signed batch record.
- Tablet & capsule countingUp to six cameras compare every tray with its expected quantity: OK, SHORT, OVER or NO_TRAY.
- GxP & 21 CFR Part 11Audit trail, e-signatures and a GAMP 5 validation kit: what QA needs to qualify a vision system.