FAQs: Standards

Perceptor IoT complies with ISO 15416 for 1D barcoding and with ISO 15415 for 2D barcoding. 

ANSI and ISO standards are becoming harmonized and aligned but it is is important to check that the ANSI standard to which you comply is now aligned with the corresponding ISO standard.

1D:

• ISO 15416
• EAN-8
• EAN-128
• EAN-13
• UPCA
• UPCE
• 2of5 Interleaved
• Code 39
• Code 39 Extended
• Code 93
• Codabar
• GS1 Databar
• GS1 Databar Limited
• Pharmacode

2D:

• ISO 15415
• DataMatrix
• GS1 DataMatrix
• QR Code
• PDF417

Yes, Perceptor IoT is classified as SC4 - Configured Product. Perceptor IoT is now licensed as a configured product. Internal testing confirms dependable functionality without errors and the final end-user product does not allow customisation, only configuration.

This classification means validation is required: the supplier must be audited, configured programming managed, and operation verified against user requirements.

Yes. A formal Computer System Assessment (CSA) confirmed that the system generates, stores, and supports GxP data used in production and regulatory record-keeping. It is classified as SC4 and must be validated.

A full Data Integrity Assessment confirmed ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate) are satisfied. The system is also assessed against FDA 21 CFR Part 11 for electronic records and electronic signatures.