21 CFR Part 11 refers to the section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration’s (FDA) guidelines on using electronic records and electronic signatures. Chapter 21 covers all regulations pertaining to GCP (Good Clinical Practice), GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice), relating to the pharmaceutical and healthcare industries. Part 11 covers all FDA regulated issues pertaining to electronic records and electronic signatures.

All computer systems that store data used to make Quality decisions or data that will be reported to the FDA must be compliant with 21 CFR Part 11. The purpose of the law is to define the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. The regulation requires organizations to have in place three levels of control: administrative controls such as policies for electronic records, procedural controls such as SOPs for using the system, and technical controls for the functions built into software that ensure the reliability and integrity of electronic records and signatures. Software can be designed to facilitate compliance with 21 CFR Part 11 technical controls, but it is the user who is responsible for providing policies and procedures to ensure their policies and procedures are fully compliant with the regulations.

Beckman Coulter’s CytoFLEX flow cytometer Platform with CytExpert 2.3 Software has features that were designed to facilitate user compliance with 21 CFR Part 11, when installed using the Electronic Record Management option.

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