2004N-0133 - Part 11 Public Meeting; June 11, 2004
FDA Comment Number : EC11
Submitter : Ms. Kate Townsend Date & Time: 05/14/2004 06:05:17
Organization : BusinessEdge Solutions
Drug Industry
Category :
Issue Areas/Comments
Part 11 Subpart B. Page 18593 Question 1. (Note, I'm assuming that this question should be referring to 11.10(a) rather than 11.10(b)).

Outside of FDA regulated industries, software quality management processes and procedures are followed because they make good business sense, not because of regulatory requirements. So why would we want to remove the validation requirement from 21 CFR Part 11, since it is our equivalent of software quality management? Obviously the extent of validation performed has to be based on a risk assessment to determine the impact on product quality and patient health and safety but removing this requirement from the regulation would be sending the wrong message. FDA needs to be encouraging industry to take a quality, value-add, approach to systems implementation and maintenance and not just look at compliance and validation as an overhead and a paperwork exercise. This presentation will address why the requirement for validation to meet predicate rule requirements should remain and how the wording could be amended to provide more quality context for the requirement -
Kate Townsend
Solutions Partner
BusinessEdge Solutions
Tel: 610-454-9830