21CFR Part 11 Regulation Compliance

21 CFR Part 11 is composed of two major subparts, Electronic records and Electronic signatures, that provide guidelines that regulated companies must minimally follow to achieve the level of integrity, reliability, and consistency of electronic records and signatures acceptable to the Food and Drug Administration (FDA). Complying with the Part 11 regulation requires a combination of strong management procedures and computer systems that meet the technical aspect of the guideline such as application security, audit trails, and password protection.

Rockwell Automation works with the life science industry to confirm that products like FactoryTalk Optix include features that are capable of satisfying the technical requirements of the 21 CFR standard, Part 11. As such, FactoryTalk Optix Studio is flexible and configurable to meet the various SOPs and implementations needed to facilitate compliance with this regulation. However, each customer’s security and standard operating procedures (SOPs) for supporting this regulation are unique.