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?

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

21 CFR Part 11 compliance for Electronic Medical Records 2017

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