There have been no substantive changes from the 2007 version.The FDA’s Investigations Operations Manual provides guidance to FDA inspectors on conducting manufacturer inspections. There is a sub-section 5.3.8 on records with sub-section 220.127.116.11 and 18.104.22.168 that is relevant to electronic records. An excerpt of these sections is at the link provided.
Companies should may want to refer to this in planning their approach to respond to FDA inspector requests for electronic copies, CD-Rs, and diskettes and should expect inspectors to follow these guidelines. This manual is updated annually each spring.
Other SoftwareCPR Keywords: 21 CFR 11, Part 11, Electronic Records