Medical manufacturers who track their documentation electronically and must maintain records or submit information to the Food and Drug Administration (FDA) are subject to the FDA regulation CFR Part 11 of title 21 of the Code of Federal Regulations (21 CFR Part 11). To be compliant, medical OEMs must meet the electronic records and electronic signature guidelines set forth by the FDA.

Some medical device manufacturers are also required to meet the FDA 21 CFR Part 820 Quality System regulation. This requires device manufacturers to have a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the United States.

The Omnify PLM system helps medical device and medical equipment manufacturers fulfill these FDA requirements by providing features such as password-protected signoffs, authorized electronic signatures, history tracking for electronic audit trails, a closed-loop CAPA system, and training requirements management.

Key advantages of leveraging Omnify Software to meet FDA 21 CFR requirements include:

• A controlled environment to manage all of your product data (bill of materials management, documentation control, change control, CAPA/quality management, training)
• Password-protected signoffs and authorized signatures manage user authentication and authorization
• Signoffs are processed on a per stage basis to enforce permitted sequencing of steps
• Automated history tracking for electronic audit trails
• Defined User Roles to control accessibility
• Closed-loop Corrective and Preventive Action (CAPA) system
• Training Monitor for identifying and documenting training needs
• Easy reporting and analysis (custom reports, DMR/DHR/DHF reports, customizable dashboards)

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