The Diagnostic Imaging and Therapy Systems Division of the National Electrical Manufacturers Association submitted comments on the Draft Part 11 Guidance.
Key points in the comments include:
– a request to include specific guidance on validation of hybrid systems
– a statement that the guidance is inconsistent with FDA’s own General Principles of Software Validation Guidance for example in the area of validation of off-the-shelf software.
– objection to FDA’s inclusion of draft documents as within the scope of Part 11 and a request to resolve scope issues.
– a request for FDA to allow electronic records to be exempt from Part 11 while they are in draft from.
A link to the full memorandum is provided.