With every major release, Enzyme prepares a validation package for our customers.
This validation package contains:
- Release Notes
- Cucumber tests
- Validation summary
- Circle CI report
- Manual Validation Report (per the details of the major release)
- Export of Enzyme eQMS User Needs
- Export of Enzyme eQMS Requirements
These documents can be used to update your internal processes and work instructions.
The validation package is available for users with the permission level of Quality Owner, under the Other tab in the Document Library
From the User Settings menu, select Document Library.
Once in the library, click on the Other tab and you will see the validation package.
For background on the requirements for validating an eQMS like Enzyme, this blog post might be helpful: FDA and Software Assurance: A Solution to the Validation Impasse
If you have any questions, you can reach us through the in-app chat or email us at email@example.com.