Table of Contents
Industry Coalition on 21 CFR Part 11
Who are we?
Value of the Regulation
Value of the Regulation
Value of the Regulation
Coalition Position
Recommendations
Electronic Records and Signatures
Implementation Timing
Implementation Timing
Risk/Benefit Driven Approach
Risk/Benefits Driven Approach
Commercially Available Software
Commercially Available Software
Commercially Available Software
Long-term Archiving
Economic Impact Analysis
Economic Impact Analysis
Guidance
Summary
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