In addition to the standards and compliance types we have outlined previously, some industry-oriented standards and certifications exist. In this section, we will focus on biomedical and healthcare rules and certifications along with those present in the financial community.
Biomedical devices are frequently deployed as part of IIoT footprints. Device makers that seek certification from the US Food and Drug Administration (FDA) must demonstrate adherence to FDA standards. The Code of Federal Regulations (CFR) Title 21, part 11 sets the rules for technology systems that manage data used by organizations under FDA oversight, including the devices and systems that govern GxP processes such as the following ones:
- Good Laboratory Practices (GLP)
- Good Clinical Practices (GCP)
- Good Manufacturing Practices (GMP)
The best practices defined in this...
