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.

Downloads:

	White Paper: 21 CFR Part 11 Risk of Noncompliance
	White Paper: 5 Ways to Ensure System Compliance with 21 CFR Part 11
	White Paper: 21 CFR Part 11 - Are You Ready for an FDA Inspection?
	White Paper: 21 CFR Part 11 Computer Systems Validation (Risk Mgmt. Plan)
	White Paper: 21 CFR Part 11 MasterControl Product Positioning
	Product Data Sheet: MasterControl Integrated Quality Management Software Suite Overview