21 CFR Part 11 - Risk of Noncompliance White Paper

7-page white paper addresses major concerns about interpretation of Part 11. It describes FDA's clarification of two points: (1) FDA intends to interpret Part 11 narrowly; and (2) the agency is taking a risk-based approach in enforcing compliance to some of the technical controls for Part 11, such as validation, audit trails, record retention, and record copying.