Compliance

Always meet your sector requirements with Perceptor IoT

Read our blog post

“How to achieve compliance & avoid chargebacks”.

2 minute read.

Depending on the industry you work in, various levels of labelling compliance are required. At its most stringent, meeting regulation and compliance requirements in Aerospace, Defence, Healthcare, Life Sciences, Medical Device and Pharmaceutical manufacturing sectors can be onerous and complex.   

Product lifecycle

Regulatory authorities require that accurate, correct and compliant information is printed on labels to ensure that products are safely identified for the patient, the surgeon, the consumer, as part of an assembly or integration into a final product or later identification in the product lifecycle.   

Compliance, quality and integrity - from Perceptor IoT 

Label content

Product information printed on a label can comprise of an extensive complex array of content including; indications of use, identification symbols, precautions, warnings, dosage, batch/lot and expiry as well as unique serialization. 

Product integrity

Each of these printed content are critical and ensuring they are not only correct but printed to exacting print quality standards and data content formats, is essential. Any errors or omissions will directly impact product integrity and, in the case of medical, life sciences and pharmaceutical, impact patient safety. 

“We passed our full validation for DPBVS flawlessly. It was a long road - 3k plus hours for all the team combined. Thanks again for your patience as we could not have done it without the help and response from the most solid software team I have ever worked with. The product’s outstanding stability means it has worked fantastically for 10 years with zero issues and no medical recalls. Now we are ready for another 10 years - keeping our patients safe with the right medical products, yet again!”

Benjamin Olinger, Business Asset Owner - DePuy (Warsaw, IN)

Enable the compliance process with Perceptor IoT

Perceptor IoT integrates with 3rd party labelling management and serialization systems
and inspects and verifies labels at the time of print. 

Every label is inspected and passed or failed:

  • Failed labels are destroyed with full overstrike 

  • Data content is validated to ISO standards 

  • Machine readable codes are verified to ISO standards 

  • Print quality is monitored with blemish control 

  • Serials are checked for validity and duplication 

  • User access is controlled 

  • System activity and events are captured in an audit trail 

Meet and fulfil compliance requirements

  • 21CFR Part 11 

  • EU MDR/IVDR Regulation (EU) 2017/745 

  • Falsified Medicines Directive 2001/83/EC 

  • GS1-128 Data Structures 

  • GS1 1D/2D code specifications 

  • ISO/IEC 15418 / ANS MH10.8.2 data structure analysis 

  • UDI ‘Unique Device Identification’ for Medical Devices 

  • IUID/UID ‘Item Unique Identification’ for MIL STD 130N 

  • (EU) 2018/574 Tobacco Regulation 

Verify and grade your codes 

Ensure your printed codes meet exacting print quality standards. Perceptor IoT is compliant to ISO/IEC 15426-2:2015 and verifies and grades codes to: 

  • ISO/IEC 15415:2011 for printed 2D codes 

  • ISO/IEC 15416:2016 or ANSI X3.183 for 1D barcodes 

  • ISO/IEC 15434:2019 for print quality 

  • In accordance with GS1 specifications