Organizations required to comply with the FDA's 21 CFR Part 11 standard know it can be a real pain. Luckily eLeaP has made Part 11 compliance easy. Here are the steps to take to ensure E-Signatures are submitted by your users.
- Toggle the E-Signature feature to ON - from your Course Definitions tab
- Once a course has the E-Signature designation enabled, assigned users are then required to submit their login credentials to digitally sign the course per the FDA's Part 11 regulation.
- If the correct credentials are entered and the [SIGN IN] button is clicked, the course is then set to the Completed status
- Course instructors now have a E-Signature log they can download and share with relevant parties.
Here's a short video (no audio) of the E-Signature at work