SMB Validation

FDA has issued a new guideline on data and time. It is not mandatory that it is local?

You are correct. The just-released draft Guidance Document on Time Stamps for E-Records and E-Sigs can be found here. The Agency has reconsidered their position on local date and time stamp requirements. The draft guidance document reflects their current thinking, and supersedes the position in comment #101 of the Rule with respect to the time zone that should be recorded. The document states, "You should implement time stamps with a clear understanding of what time zone reference you use. Systems documentation should explain time zone references as well as zone acronyms or other naming conventions."