Docket Management
Docket: 03D-0060 - Draft Guidance: Part 11, Electronic Records, Electronic Signatures--Scope and Application
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Mrs. Karen Ashworth Date/Time 2003-03-03 04:44:22
Organization Karen Ashworth Consulting Ltd
Category Company

Comments for FDA General
1. General Comments Additional clarification on the status of software / configurations would be helpful. Are they a required GxP record - as suggested by compliance policy guide 7132a.11 - because, if so, they appear to be 'in scope' as the master must be maintained in electronic format in order to be useful. As stated in the ISPE submission 'Risk-Based Approach to 21 CFR part 11', other approaches (validation, configuration management, change control, etc) are already in place to ensure software meets GxP requirements. To require full automatic audit trailing of software changes therefore adds little 'risk reduction' value whilst restricting (often to the point of none being available) the choice of technological solutions.

EC -1