Whitepaper: 21 CFR Part 11 Compliance with Cognex

How machine vision technology helps control quality while speeding up delivery


Pharmaceutical and medical device companies are modernizing their manufacturing practices by introducing more sophisticated and automated systems like machine vision technologies, including deep learning, barcode reading, and barcode verification. These systems perform quality control and ensure full track-and-trace capabilities and need to comply with regulations like 21 CFR Part 11.

Additionally, COVID-19 has accelerated the need for automation in pharma, life science, and medical device manufacturing. Manufacturing COVID-19 test kits and vaccines require full automation at scale while maintaining safety and compliance to serve the needs of human population.

Vision systems are essential for full automation. The issue of how to ensure vision system compliance with the requirements of 21 CFR Part 11 is a topic that has only been made more significant by the demands now being put on them.

This whitepaper in partnership with Cognex, attempts to provide some considerations on thinking through the deployment of vision-based automation in pharma and medical device manufacturing while staying 21 CFR Part 11 compliant. CXV Global also discusses how an entire pharmaceutical packaging hall was brought into compliance by the installation of the CXV Global LineDirector on all lines.


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