Egnyte Life Sciences GxP plans with Workflows offer the following additional features beyond the standard Workflow features.
Reason for Change
You can optionally add a reason for change while creating any type of workflow. This field allows you to explain why a new document is being created or an existing document is being updated.
Digital Signatures for Approval
Life Sciences GxP plans with Workflows have an additional option to require 21 CFR Part 11 compliant digital signatures from approvers.
When a digital signature is required for approval, a signature screen will be shown asking you to enter your username, password, and a reason for approving the document. There is a complete audit trail available for all the digital signatures and document approvals.
Reviewer and Approver Authorization
Our system only allows authorized users to participate in the review and approval process. All of the reviewers must be added to the WorkflowReviewers group and approvers must be added to the WorkflowApprovers group. This ensures that only authorized users can review and approve the documents.
As a part of your initial domain setup, you will need to create these two specific groups WorkflowReviewers and WorkflowApprovers. Please remember to use exact spelling and capitalization for creating these two groups. Once groups are created, you will need to add the users who are going to participate in the review and approval process. Refer to Add a New Group article to learn more about creating new groups and adding users to a group.
PDF rendition of Approved document
For the documents approved with a digital signature, the approved copy of the document can be downloaded in a human-readable PDF rendition that includes a signature page at the end. The Signatures page includes a list of users approving the document, the reason for approval, and the date and time stamp of each signature.
Approved Document Retention
Approved documents are retained forever, preventing users from purging the data from the system. Workflows and digital signature records are also permanently retained and cannot be deleted.
Complete Audit Trail
All actions taken as part of a workflow and the comments associated with a workflow are tracked in the Workflow audit report. Workflow audit reports include the reason for change and the selected reason for approval while capturing digital signatures during the document approval process.