Q: What are FDA’s expectations for electronic notebook validation, including those used by chemists or other scientists in discovery research?
A: FDA doesn’t expect you to validate electronic notebooks used strictly for discovery research. However, if you use data from electronic notebooks to substantiate clinical work or animal studies, you must be able to demonstrate that the information was created and kept in a way that ensures its providence (e.g., identifies the original data, documents who created the data and when, tracks any changes made, etc.)
So if you do decide to validate the electronic notebooks and the applications running on them, validate them for their intended use and for the security and chain of custody of the data.
Answered by Janis Olson, Vice President of Regulatory and Quality Services, EduQuest, and co-developer and instructor of EduQuest’s 3-day training class, FDA Auditing of Computerized Systems and Part 11/Annex 11 Compliance.