The FDA's Code of Federal Regulations Title 21 Part 11 defines the requirements for using electronic records and electronic signatures on computerized systems. The integrity, reliability, and trustworthiness of electronic records must be fulfilled as for 21 CFR Part 11 basic requirements.
The whole workflow in the laboratory is subject to 21 CFR Part 11 regulations, thus full compliance can only be achieved by analyzing activities and defining in detail how sample-handling steps, experimental methods, and use of instruments should be performed.
The chain of data custody, the risk of system failure, and control measures are fundamental aspects when designing 21 CFR Part 11 compliant laboratory workflows.
Compliance is therefore not limited to installing software or instruments that support 21 CFR Part 11 compliance, but they are at the core of it.