21 CFR Part 11 of the Code of Federal Regulations deals with the United States Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.
Practically speaking, Part 11 requires drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions, to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are (a) required to be maintained by the FDA predicate rules or (b) used to demonstrate compliance to a predicate rule. A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11.
More and more, today’s manufacturers are challenged with complying with the increasing regulation of their processes. The importance of ensuring that only authorized persons are able to modify the process, and that every modification be reliably recorded in a way that protects it against manipulation, cannot be understated. Before any product can be sold, a production plant and/or process must be validated and authorized by inspectors to make certain that the plant complies in every way.
Previously, all documents and signatures had to be committed to paper; today, after fulfilling specific prerequisites, data can be electronically collected and stored to fulfil the conditions required for validation. The U.S. Food and Drug Administration (FDA) define these prerequisites in the FDA 21 CFR Part 11 regulation. This functionality can be integrated into HMI & SCADA software, providing compliance with these regulations for electronic records and signatures. Quickly and easily implemented, these systems optimize the manufacturing process and improve quality.
Validation and FDA 21 CFR Part 11 Integrated into HMI’s & SCADA
FDA 21 CFR Part 11 describes the use of electronic records and electronic signatures. It defines time-stamped data via access control, electronic signature, audit trail, change control and archiving.
As an example the Siemens SIMATIC WinCC SCADA system in combination with the Audit and SIMATIC Logon options makes your application "ready for validation”. Full compliance with FDA 21 CFR Part 11 is achieved, along with additional administrative and procedural controls.
Today, process optimization and simultaneous compliance with FDA regulations is the main requirement in the pharmaceutical industry, with increasing presence in other industries. The use of electronic records and electronic signatures to FDA 21 CFR Part 11 serves this objective.