This article deals with Extended Approval, which is an add-on product for Cognidox customers, primarily in the medical device development industry. However, it is useful for any organization seeking compliance in other regulation spaces.
Videos in this article
Overview
We developed this add-on so that our customers can easily comply with the e-signature requirements of FDA 21, CFR Part 11 and GXP data integrity requirements. It's important to make sure that those who approve documents are who they say they are. So we have some options to choose from. The ones covered in the video are:
- Cognidox password and username
- Using an authenticator app on your mobile device.
Watch the video
Check out the video, then take a look at the summary below.
- Extended approval (also referred to as Authentication on approval) requires a user to re-authenticate to approve certain documents by entering their username and password, or their username and authentication token. It also allows extra information to be collected at the approval stage, such as the user’s role, and the meaning of approval.
- Once approval is achieved, an approval manifest is generated and attached to the PDF version of the document, and this is able to be verified on the system when necessary using unique checksums.