Regulations Overview Page

Pharmaceutical & Medical

Regulations

Machine vision and barcode reading systems that support regulatory compliance

Life science, biotech, pharmaceutical, and medical device manufacturers are facing regulatory requirements that affect the compliance of their vision and labeling systems. These include FDA 21 CFR Part 11, for digital records submitted electronically for regulated FDA filings, and Unique Device Identifier (UDI) requirements for device labels and packages. Similar versions of these regulations apply in the US and the EU. Cognex vision systems support 21 CFR Part 11 compliance and the integrated label management across supply chains required by UDI.

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Regulations Application Segments

in-sight reads vaccine kit packaging under film wrap

21 CFR Part 11 Regulation

A closer look at how vision systems help ensure 21 CFR Part 11 compliance related to accessibility, audit trails, and validation.

In-sight 8000 reading UDI codes on medical device

UDI/MDR Regulation

Explanation of how machine vision systems help identify and track individual medical devices to remain in compliance with governing bodies.

in-sight reads vaccine kit packaging under film wrap

21 CFR Part 11 Regulation

A closer look at how vision systems help ensure 21 CFR Part 11 compliance related to accessibility, audit trails, and validation.

In-sight 8000 reading UDI codes on medical device

UDI/MDR Regulation

Explanation of how machine vision systems help identify and track individual medical devices to remain in compliance with governing bodies.

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