BLOG: Is your label inspection process really audit-ready?

Audit - that's a word that strikes fear into many a professional's heart.

Not least the label production managers that the Perceptor team speaks to. They strive to be audit-ready but then they are asked for a label record from batch 4471-B that ran 18 months ago - with individual inspection results, operator details, vision template reference and a full pass/fail log for the entire batch.

That's when 'audit-ready' becomes 'frantically searching spreadsheets'.

Under FDA 21 CFR Part 11 and EU MDR requirements, your label inspection data isn't just an operational record - it's a compliance asset. Inspectors – and your customers - want to see records that are complete, tamper-evident, and retrievable on demand.

Four things we hear of that trip up label quality and compliance teams are:

- Inspection records stored in a way that anyone can edit them without a trace - if they are recorded at all...
- Inspection data that lives only in the local machine/inspection station and can't be exported for review and checking
- No operator-level attribution — just a label pass/fail marker
- Differing manual label rejection criteria - used by different operators across different shifts at manufacturing sites producing labels for the same products.

If any of those sound familiar, it's worth a conversation with us about Perceptor IoT – the real-time, global, secure and compliant label inspection and verification solution.

What's the one part of your label inspection process or audit trail that keeps you awake at night? Get in touch with your worse-case audit scenarios and we’ll be right back with the solution.