What is 21 CFR Part 11?
In 1997, the Food and Drug Administration (FDA) issued Part 11 of Title 21 defining the criteria under which electronic records and signatures are considered equivalent to paper records and handwritten signatures. As much controversy and confusion this regulation has caused over the years, it will actually make your life easier and clutter-free by creating a compliant and paperless quality management system.
Who Does it Affect?
The 21 CFR Part 11 regulation applies to all FDA regulated industries, but mainly to any Life Sciences company that wants to research, manufacture and sell their product or services in the United States. Part 11 also applies to electronic records submitted to the FDA under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.
Here is the FDA’s 5-step approach to comply with Part 11 requirements:
- Validation – Aside from complying with all applicable predicate rule requirements for validation, consider the impacts the computerized system(s) will have on the accuracy, reliability, integrity, availability, and authenticity of required records and signatures.
- Audit Trail – If there are no rule requirements to document (i.e., time, date, or sequence of events) the FDA suggests providing an audit trail for other appropriate measures in place that will ensure product quality and safety, as well as record integrity.
- Legacy Systems – The FDA does not intend take enforcement actions for systems that were operational prior to August 20, 1997, as long as the system met the requirements before the effective date and there is documentation stating it is fit for its intended use.
- Copies of Records – All records are subject to inspection. Investigators must be provided with access to records during an inspection for review and copying.
- Record Retention – The FDA enforces the protection and availability of records throughout the records retention period. If the requirements are fully satisfied and the content and meaning of the records are preserved and archived, the electronic version of the records can be deleted.
The MadgeTech 4 Secure Software aids customers in compliance with 21 CFR Part 11 requirements. The software ensures standards in which electronic files are considered equivalent to paper records, saving time and effort. MadgeTech 4 Secure Software contains criteria such as electronic signatures, access codes, secure data files, and an audit trail which meet 21 CFR Part 11 requirements and help provide data integrity.