21 CFR Part 11 compliance for Electronic Medical Records 2017 covers topics such as:
- What is the relationship between "validation" and "part 11 compliance" to electronic medical records?
- Review of current status of 21 CFR Part 11
- What changes can I expect to see in Part 11?
- What do I have to do today to be in compliance?
- What is the future part 11 likely to look like?
- When will I need to be in compliance?
- How can I ensure what I do today will stand inspection tomorrow?
- How can I best integrate part 11 compliance into my quality system?
21 CFR Part 11 compliance for Electronic Medical Records 2017 brings together:
- QA Directors, Managers and personnel
- Management responsible for operational and quality systems ("system owners")
- Software validation and software quality managers + personnel
- IT / IS managers and personnel
- Programmers, developers, project managers and others responsible for bringing systems online in a compliant manner
- Consultants charged with creating or evaluating part 11 programs
- Quality auditors responsible for auditing and evaluating part 11 compliance
