16.part11.rar 〈95% RELIABLE〉

: Secure, computer-generated, time-stamped records that track all changes to electronic data without obscuring previous entries.

Because .rar is a compressed archive format, you will need utility software to access the "Part 11" draft report within it: : 7-Zip or WinRAR . macOS : The Unarchiver . 16.part11.rar

: Documented proof that a system performs consistently and as intended. Electronic Records - FDA

: Guidance on how to handle systems operational before August 1997, where the FDA may exercise enforcement discretion. 16.part11.rar

If you are looking for the official FDA on Part 11 rather than a specific private archive, you can view the primary documentation on the FDA website . Guidance for Industry - Part 11, Electronic Records - FDA