View Full Version : FDA 21 CFR Part 11 - Electronic Signatures and Gait Files

Draper, Edward
07-08-2002, 01:13 AM
Dear All

I have an intriguing problem with which you may be able to help.

I need to inlcude some of our gait files in a study to be submitted at
sometime in the future to the FDA - and being a 'computerised system' the
files need to have electronic signatures.

The guidance is clear that I need to run a system that requests the
signature BEFORE the data capture. But the system we run has no such

I was proposing to encrypt the files immediately AFTER capture -
appropriately signed and time-stamped but our QA people say that is too

Has anyone had to face this problem?

If so, how have you added electronic signatures 'retrospectively'?

Many thanks


Orthopaedic Research Fellow
Imperial Collge, Royal Veterinary College

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