As a part of Artificial’s 21 CFR Part 11-Ready Package, Assistants can be put in a “Compliance Mode.” Compliant Mode Assistants enable two critical features:
- Enforcing users to complete and check each step of the Assistant in order
- Enables signature widgets for user sign-offs
To create a Compliance Mode Assistant, you can check the “Compliance Mode” box when you are creating a new Assistant. If you want to make an existing Assistant compliant, go to the Assistants table, click the three dots of the specific Assistant, and select “Compliant.” This will automatically force users to complete the Assistants in chronological order.
To use the Signature widgets, you will need to:
Create Signature Groups
To create a Signature Group:- Go to “Settings”
- Select your Lab
- Go to the “Signature Groups” section and “Add Group”
- Name the group
- Add the relevant users to that group
Set up One-Time Passwords
Every user in a signature group will need to set this up in Artificial. To do this, you will also need to use an Authenticator (Google or Microsoft) app. To complete this process:
- Go to Settings
- Under your name, go to “One-Time Password”
- Follow the instructions from there
Add and Configure a Signature Widget
To add signature widgets, open the Assistant editor and go to the step/task to which you want to add the widget. Then, select “Add User Prompt” and “Signature.”
This will add a Signature widget with configuration fields:
- Signature Groups: What groups may be required to sign
- Signature Rule: Indicate whether one from any of the selected groups or one from each of the selected groups is required to sign
- Signature Reason: Indicate if this is a signature for approval, acknowledgment, or certification