2003D-0060 - Guidance for Industry on Part 11, Electronic Records; Electronic Signatures--Scope and Application Availability
FDA Comment Number : EC30
Submitter : Mr. Patrick Chiu Date & Time: 06/10/2004 05:06:16
Organization : Aslan Consulting Services, LLC
Drug Industry
Category :
Issue Areas/Comments
GENERAL
GENERAL
If one can just spend some time to read and understand the preambles, one would decide that the current guidance document is fair and flexible. The overall Part 11 approach is consistent with other predicate rules..in a nut shell: to spend time and understand the system, challenge to system according to the user requirements, design specs, and take the time to document the test results, and investigate/justify deviations. Perform a good computerized system validation and part 11 is automatically covered.