FDA 21 CRF 11 & Annex 11

Title 21 CFR Part 11 is the portion of the Code of Federal Regulations that provides standards determined by the Food and Drug Administration (FDA) on electronic records and electronic signatures. With electronic records widely used in the Life Sciences industry, most companies will find FDA 21 CFR Part 11 applicable.

Regulated companies with documents or records in electronic format must comply with FDA 21 CFR part 11. Part 11 pertains to pharmaceutical companies, manufacturers of medical devices, biotechnology companies, CROs, biologics developers, and other companies regulated by the FDA.

Part 11 helps companies safely maintain data securely so that it is not lost or corrupted, ensures companies are implementing systems and software correctly, makes sure there are data-trace changes and prevents falsified records.

Modules include:

• Impact of 21 CFR Part 11 on the organization's computer systems, including Quality Management Systems
• Identification of the organization's computer systems and operating environment
• Hosting and interpretation of user interviews
• Review and consideration of organizational procedures
• Analysis of procedural documentation, validation, and audit data
• Regulatory significance of the computer systems
• Annex 11 for European Union compliance