2004N-0133 - Part 11 Public Meeting; June 11, 2004
FDA Comment Number : EC12
Submitter : Ms. Kate Townsend Date & Time: 05/14/2004 06:05:32
Organization : BuinessEdge Solutions
Drug Industry
Category :
Issue Areas/Comments
Part 11 Subpart A Question 1.

The Part 11 guidance document helps to define the scope of Part 11 by providing further explanation and giving examples. This is useful information but too detailed to be included in the regulation itself. However, it provides an illustration of how the scope of the regulation needs to encourage industry to look beyond the records themselves. Business processes surrounding the use of electronic records and electronic signatures need to be considered when determining the application of the Part 11 regulation. Not looking at the context is a mistake that was made by many when systems were assessed for Part 11 compliance and resulted in the 'scope creep' which FDA is now trying to avoid. This presentation will make a case for changing section 11.1 Scope of the regulation to encourage consideration of the business processes surrounding the records as well as the records themselves when determining the application of Part 11 -
Kate Townsend,
Solutions Partner,
BusinessEdge Solutions,
Tel: 610-454-9830