BLOG: Don’t just meet compliance standards - stand out from the rest!

If you're really into labels (as we are) then you'll know that having electronic label records isn't enough.

It's a good start, but it’s also the part of 21 CFR Part 11 that trips up a lot of label production teams working with lots of compliance. They've moved away from paper. They have digital inspection logs. They assume that's what the FDA wants to see.

But Part 11 isn't just about format — it's about integrity.

Your electronic label records need to be:

- Operator-attributed (not just 'system logged')
- Protected against alteration – at least not without a traceable audit entry
- Retrievable in a format that can actually be reviewed
- Linked to the version of the label specification that was active at the time

The same applies under EU MDR; article 10 puts the ongoing label verification burden on the manufacturer — so 'we inspected it at launch' isn't a complete answer.

The teams who sail through regulatory inspections aren't necessarily doing more work. But they do have a label inspection system and processes in place which capture the right data, in the right way, at the point at which every label is printed.

We’d love to show how Perceptor IoT helps you get it right every time - we have lots of before and after stories to share and relish a problem to solve! Get in touch with your ‘before’ story and we’ll help get you to the right place.

In fact, why not put Perceptor IoT to the test with a free soft copy trial - we'll set up your test labels and you can run our inspection and verification solution from the comfort of your desk.