Ofni Systems Inc. training

Educate your personnel to the requirements of 21 CFR 11, Electronic Records: Electronic Signatures. This course reviews the text and common interpretation of 21 CFR 11, including technological and procedural controls required for systems to be compliant with the regulation. The course includes a 30-minute Q&A, with a compliance expert answering any specific questions your organization may have relating to compliance with 21 CFR 11. (2 hours).

Ensure your compliance with 21 CFR 11.10(a). This course teaches you how to validate all of your computer systems. Attendees will learn how to gather system requirements; transform requirements into user requirements, functional specifications, and design specifications; create appropriate testing protocols; and how to maintain validated systems. Training includes case studies and best practices for specific computer systems. (1-day, 2-day, 3-day, and 1-week curricula available).