Title 21 CFR Part 11  defines the FDA's criteria to ensure electronic records and electronic signatures are secure and trustworthy. 

In Enzyme, Part 11 compliance can be achieved by requiring a PIN to approve any items. 

Note: This video was created using V1.25. Enzyme is updated weekly so some elements may change.

 Admins (Quality Owner) can enable Part 11 compliance under Company Settings. Once enabled, users will have to set a PIN before approving any items within Enzyme. 

To set/reset your PIN, access your User Profile.

1. Set PIN for the first time

If you are setting your PIN for the first time, enter the New PIN and New PIN Confirmation. The PIN must be 4 characters long.

When done, scroll to the bottom and be sure to click Save Changes

Now, before you approve any items, you will be asked to enter the 4 character PIN you just created. 

2. Update PIN

Once you have created your PIN, you can always update it. To do, first enter your current PIN and then your new PIN and new PIN confirmation.

When done, scroll to the bottom and be sure to click Save Changes

Your new PIN will be saved.

3. Reset PIN

To reset your PIN, click on the Reset PIN button. 

You will be asked to confirm if you want to indeed reset the PIN.

Once you click OK, you will receive an email with your temporary PIN

Enter that temporary PIN as the Current PIN and enter a New PIN and the New PIN conformation. 

Once you Save Changes, the New pin will be set. 

Note: Quality Owners can access the full Part-11 compliance report in the Other tab in the Document Library. 

If you have any questions, you can reach us through the in-app chat or email us at support@enzyme.com. 

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