LabArchives will be releasing new capabilities to the platform on Oct 13th which will enhance 21 CFR Part 11 compliance.
This new workflow provides new controls for page signing and witnessing within a notebook, as well as conferring page signing and witnessing privileges to designated notebook users. The workflow facilitates communication between page signers and witnesses (or co-signers) with email notifications indicating a page is ready for review and witnessing.
These additions give notebook owners complete end-to-end workflow control following the 21 CFR Part 11 guidelines for electronic signatures in research notebooks. All signed pages, including those that are witnessed, are “frozen” and no additions or changes can be made.
LabArchives is available to users on an individual basis or as part of enterprise licenses at many research institutions around the world. Contact us or check with your Research Administration office to see if your organization has an an enterprise level agreement. If you want more information contact us at email@example.com.