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
In a regulatory or compliance context, "Part 11" refers to the criteria under which the FDA considers electronic records and signatures to be trustworthy, reliable, and equivalent to paper records. Key requirements typically covered in such reports include:
: Secure, computer-generated, time-stamped records that track all changes to electronic data without obscuring previous entries.
: Guidance on how to handle systems operational before August 1997, where the FDA may exercise enforcement discretion.
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
In a regulatory or compliance context, "Part 11" refers to the criteria under which the FDA considers electronic records and signatures to be trustworthy, reliable, and equivalent to paper records. Key requirements typically covered in such reports include:
: Secure, computer-generated, time-stamped records that track all changes to electronic data without obscuring previous entries.
: Guidance on how to handle systems operational before August 1997, where the FDA may exercise enforcement discretion.
