We released additional Admin configurations and controls to support 21 CFR Part 11 compliance for Box Sign for GxP Validation customers. There are certain situations where users within a GxP Validation account need to be able to send standard signature request that are not required to support 21 CFR Part 11 compliance. However, Box Sign's previous 21 CFR Part 11 workflow settings restricted users and groups to sending only 21 CFR Part 11 signature requests.
With this new enhancement:
- GxP Validation Amins and Co-Admins who enable Box Sign for their enterprise will simultaneously enable their end users to choose between sending standard signature requests or 21 CFR Part 11 compliant signature requests by default. Users can select whether the signature request is a standard request or a 21 CFR Part 11 signature request from a dropdown menu available in the document preparation experience when sending out an ad hoc signature request or when configuring and using a reusable template.
- Along with changes to the default Box Sign enablement settings, GxP Validation Admins and Co-Admins can now restrict certain users and groups to only send 21 CFR Part 11 compliant signature requests, ensuring their users remain in compliance with 21 CFR Part 11 guidelines for electronic signatures when initiating signature requests.
- GxP customers with the 21 CFR Part 11 setting enabled for select users and groups will automatically have those same users and groups included in the 21 CFR Part 11 restriction setting.
In tandem with these changes, users who switch from standard signature requests to 21 CFR Part 11 signature requests are prompted with a notification that signature and initials field sizes will be automatically resized due to the additional details included within the 21 CFR Part 11 signature and initials frame, and the additional recipient verification method will default to require Box account login. Additionally, users who switch from 21 CFR Part 11 signature requests to standard signature requests are prompted with a notification that signature and initials fields will be adjustable and the additional recipient verification method will be configurable.
Template creators who are enabled to use Box Sign, but are not added to the 21 CFR Part 11 enforcement setting can configure and lock the signature request type within the reusable template to prevent other users from modifying the signature request type. Moreover, users added to the 21 CFR Part 11 enforcement setting are not able to:
- Utilize standard signature request templates
- Change templates from 21 CFR Part 11 to standard when using or creating templates.
- Revise, cancel, or delete standard signature requests that appear in their ‘Shared with Me’ tab within the Box Sign home page.
- Create ready-links from standard or 21 CFR Part 11 signature request templates.
Template creators are forced to classify the template as a standard or 21 CFR Part 11 signature request when creating the reusable template. Existing Box Sign templates will automatically default to 21 CFR Part 11 templates for GxP Validation customers who have not specifically configured the template as a standard signature request template. Templates and signature requests that are configured as standard signature requests or templates are inaccessible for users who are restricted to only send and manage 21 CFR Part 11 signature requests or templates.
GxP Validation customers who are not on a controlled release have immediate access to this feature. This feature will be released to production environments for customers enrolled in the controlled release process in early November.