What is 21 CFR Part 11?

In 1997, the Food and Drug Administration (FDA) issued Part 11 of Title 21 defining the standards under which electronic records and signatures are considered like paper records and handwritten signatures. the maximum amount controversy and confusion this regulation has caused over the years, it'll 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 or any FDA regulated industries, but mainly to any Life Sciences company that desires to research, manufacture and sell their product or services within the us . Part 11 also applies to electronic records submitted to the FDA under the Federal Food, Drug, and Cosmetic Act and therefore the Public Health Service Act.

 

Here is that the FDA’s 5-step approach to suits Part 11 requirements:

 

Validation – apart from complying with all applicable predicate rule requirements for validation, consider the impacts the computerized system(s) will wear the accuracy, reliability, integrity, availability, and authenticity of required records and signatures.

Audit Trail – If there are not any rule requirements to document (i.e., time, date, or sequence of events) the FDA suggests providing an audit trail for other appropriate measures in situ which will ensure product quality and safety, also as record integrity.

Legacy Systems – The FDA doesn't intend take enforcement actions for systems that were operational before August 20, 1997, as long because the system met the wants before the effective date and there's documentation stating it's fit its intended use.

Copies of Records – All records are subject to inspection. Investigators must be given 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 wants are fully satisfied and therefore the content and meaning of the records are preserved and archived, the electronic version of the records are often deleted.

The MadgeTech 4 Secure Software aids customers in compliance with 21 CFR Part 11 requirements. The software ensures standards during which electronic files are considered like paper records, saving time and energy . MadgeTech 4 Secure Software contains criteria like electronic signatures, access codes, secure data files, and an audit trail which meet 21 CFR Part 11 requirements and help provide data integrity.