Description

With this major release we are happy to announce that the ZenSign for Documents feature is now in General Availability. We are also updating the look and feel of the module dashboards. Additionally, this release introduces some key enhancements across Documents, Training, and Public API modules, as well as bug fixes across the app.

 

Key updates include:

 

  • We're thrilled to announce that the ZenSign for Documents Module is now available as a paid add-on feature for all our clients, entering General Availability phase. This feature, is designed to enhance your document management experience by capturing 21 CFR Part 11 compliant signatures from users not registered in your ZenQMS account. Users can be verified and sign with just an email and one time password, integrating seamlessly with your existing ZenQMS document management system and providing real-time tracking of document status.
    Below is a detailed list of all requirements for this feature
    • Ability to send ad-hoc steps from Approval/Retirement workflows to External Assignees for review & signature
      • SIGN-408    Allow assigning external users to an ad-hoc step of an approval workflow, if ZenSign Module is active and user has "ZenSign: External Assignments" permission
      • SIGN-411    Launch Approval Workflow including an Ad-hoc step assigned to an external user and show the step on the Workflow/Signatures slider
      • SIGN-412    Trigger emails notifications for External User when the workflow reaches the step assigned to them and enable the external user to access the page containing the document they need to sign
      • SIGN-413    Notify external assignee if workflow is cancelled after they have already received first email notification and do no longer allow them to access document in ZenSign app
      • SIGN-417    External Assignee should  be able to download the document after the Approval Workflow they participated in is complete
      • SIGN-418    External Assignee should be able to reject document in ZenSign App
      • SIGN-421    External User should be able to access the document and the active workflow's steps in ZenSign
      • SIGN-443    Include External Assignees in the Workflow Users and Workflow Pending Signatures column from Documents Full Table
      • SIGN-444    Capture steps with external assignees in the viewed/exported PDF, depending on document category and PDF export options
      • SIGN-445    Retirement Workflow: allow assigning ad-hoc steps to external users and launch the workflow
      • SIGN-451    Track in Audit Trail the actions taken by an external assignee on a document workflow
      • SIGN-452    Retirement Workflow: External assignee can submit signature for an ad-hoc step in ZenSign App
      • SIGN-454    Show E-Signature Disclosure pop-up and update the step statuses after the external user accepts it and accesses the document in ZenSign
      • SIGN-466    Retirement Workflow: enable participants in the workflow to download retired document
      • SIGN-482    Design enhancements for highlighting steps sent for external signature on Launch Approval/Retirement and Workflow/Signatures sliders
      • SIGN-522    Improve mobile responsiveness
      • SIGN-416    External Assignee should be able to approve document in ZenSign App
    • Send Approval/Retirement Workflows steps configured at document category level for External Signature
      • SIGN-472 Document Category: Disable 'Same As Approval Workflow' for Periodic Review workflow, if Approval Workflow includes steps assigned to external user
      • SIGN-471 Document Category: Configure steps that can be sent for External Signature in the Retirement workflow
      • SIGN-531 Document Category: Approval - Major Revisions workflow: Do not allow to configure steps to be sent for external signatures if Same as Approval Workflow is selected in Periodic Review
      • SIGN-469 Document Category: Configure steps that can be sent for external signature in Approval - Major Revisions workflow
      • SIGN-470 Document Category: Configure steps that can be sent for External Signature in Approval - Minor Revisions workflow
      • SIGN-476 Workflow cancellation notifications for external assignees - External assignees receive email notifications if a workflow they are part of is canceled, providing clarity on document availability.
      • SIGN-473 Launch Document Workflows with external signature steps from ZenQMS app
      • SIGN-474 Approve/Reject Document Workflow steps as external assignee
      • SIGN-475 Enable external assignee to download PDF document after workflow completion
      • SIGN-550 When Rejecting a Workflow show the signature reason specific to rejection action in the Submit Electronic Signature pop-up
      • SIGN-477 Audit Trail for external assignee actions/events - Category Steps
      • SIGN-478 Disable ZenSign Module with active workflows
      • SIGN-557 Document Category - Approval Major Revision slider: banner shown when ZenSign option cannot be selected should include a link directing to a support article - To enhance user guidance, a banner is now shown when the ZenSign option cannot be selected, including a link directing to a support article for more details.
      • SIGN-479 Handle edge cases/exceptions/concurrency scenarios on workflows with external assignees
      • SIGN-540 Secure PDF download in ZenSign after a workflow completion - To enhance security, users are now required to authenticate in ZenSign before downloading a PDF after workflow completion, ensuring only authorized access.
  • UI/UX Cosmetic Updates and Layout Adjustments across all modules
    • ZENQ-6802 [UI/UX] Cosmetic UI Updates on All Modules Dashboards: Updated charts and tables with new UI standards for better visual consistency.
    • ZENQ-6510 Layout Adjustments on Active Modules Page: Improved visibility and alignment of elements on the "Active Modules" page.
    • ZENQ-6513 [UI/UX] Layout Adjustments on Users Page: Enhanced visual organization by aligning buttons and removing unnecessary spaces.
    • ZENQ-6512 [UI/UX] Layout Update on Notifications Page: Removed margins and adjusted page width for a cleaner look.
    • ZENQ-6514 [UI/UX] Layout Adjustments on Preferences Page: Improved visual organization by adjusting font sizes and spacing.
    • ZENQ-6515 [UI/UX] Font Adjustment on Personal Information Page: Updated font sizes for better readability.
    • ZENQ-6505 [UI/UX] Decrease Icon Size for Adding a New Link in the Link Section: Reduced icon size for a more streamlined appearance.
    • ZENQ-6502 [UI/UX] Adjust Line Height Between PDFTron Action Buttons and Collapsed Action Menu
    • AUTH-1471 [UI/UX] Add column sorting to the user assignment slider in Settings->Roles/Permissions
  • Minor Upversion: Option to update the Review Date: We've made significant improvements to the document review management process, ensuring a more intuitive and efficient experience for users managing document reviews.
    • DM-6892 When selecting Minor Upversion, modal to appear to allow user to select to update the Review Due Date or not - A new modal allows users to decide whether to update the Review Due Date when selecting a Minor Upversion, ensuring that review schedules align with user preferences.
    • DM-6893 Select a custom date when choosing the Document Review Interval - Users can now manually override the Next Review Date with a custom date, providing flexibility in scheduling document reviews. This feature is available for documents in the Effective state.
    • DM-6940 Add field "Last Review Date" to the View/Edit Document page and the Full Table - To provide better context, a new "Last Review Date" field has been added to the View/Edit Document page and the Full Table, displaying the date of the last periodic review or "n/a" if none has been performed.
    • DM-6891 Name change from "Review Date" to "Next Review Date" in View/Edit Document and Full Table pages - To clarify the purpose of the review date, the term "Review Date" has been updated to "Next Review Date" across the View/Edit Document and Full Table pages.
  • Ability to Unretire a Document Category: We've rolled out some exciting updates to our document management system, making it easier to unretire document categories.
    • DM-7094 Create Permissions for the Unretire Option - To enhance security, the "Return to Active" option is now available only to users with specific permissions, ensuring that only authorized users can unretire document categories.
    • DM-7093 Audit Trail for the Unretire Action - We've added a new audit trail record for when a document category is returned to active, providing full traceability and compliance by logging this significant action in the Account Audit Trail.
    • DM-7091 Add the Actions button with the dropdown option to unretire a document category to the retired versions - We've integrated the "Return to Active" option into the UI for retired document categories.
  • New Reports Added to the Reports Module
    • REP-553 Training: SCORM Training Report - To provide comprehensive insights into SCORM training assignments, we've added a new report that aggregates data on all SCORM training courses and results. Users can now view and download this report in CSV and Excel formats.
    • REP-549 Documents: Documents Archive Table Detailed Report - We've introduced a detailed report for documents in the archive table, showing all related metadata. This report helps in assessing performance and reliability by focusing on archived documents.
    • REP-548 Documents: Documents Full Table Detailed Report - A new report has been created to provide detailed insights into active documents, excluding archived ones. This report aims to improve performance and reliability by focusing on active document data.
    • REP-539 Documents: Document Archive Report - This report shows how documents were archived, whether marked obsolete or upversioned. Users can now directly download this report from the Reports Library page, supporting CSV and Excel formats.
  • Link comment fields from Signature Sliders to Account Audit Trail: we are rolling out this functionality across other areas of the application
    • DM-7028 Update the Documents → Force Selected Users To Retrain in order to have the e-signature slider request and link the Comment input under the Account Audit Trail table
    • DM-7037 Update the System generated comments to have a prefix as "System Comment: '<Generated by the system>'" - To improve clarity, system-generated comments in the audit trail now have a prefix "System Comment: '<Generated by the system>'", ensuring that users can easily distinguish between system and user-generated comments.
  • Updated functionality in Insights module designed to enhance your data visualization and reporting capabilities.
    • INSIGHT-371 Insights dashboards available in language preference of the user - each dashboard within the Insights module can be translated to the user's language preference. This ensures a more personalized and accessible experience for users worldwide
    • INSIGHT-578 Insights: Ability to export dashboards to Excel - users can now export their dashboards to Excel (XLSX format). This feature allows for easier data manipulation and sharing outside the platform.
    • INSIGHT-579 Insights: Ability to view widget visualizations as tables - This provides a more structured and detailed view of your data.
  • Enhanced Localization for Audit Reports module - This update focuses on localizing various components within the Audit Report interface, making it easier for users to utilize our platform in their preferred language
    • ZENQ-6766 [Localization]Edit Audit Report -> header and Audit Details Tab: localize all the content
    • ZENQ-6767 [Localization]Edit Audit Report -> Audit Report tab: localize all content
    • ZENQ-6768 [Localization]Edit Audit Report -> Observations tab: localize all content
    • ZENQ-6769 [Localization]Edit Audit Report -> Workflow tab: localize all content
    • ZENQ-6848 [Localization]Add Audit Report: localize content
    • ZENQ-6849 [Localization]Edit Audit Report: localize strings related to "I am uploading a Client or Regulatory Audit of my GxP site" option
  • Other enhancements across the application
    • DM-6447 Document Workflows: Allow Simultaneous Ad-Hoc (Additional) Workflow Steps for all workflow types - We've enhanced the document workflows to allow simultaneous ad-hoc steps, enabling more efficient document approval processes.
    • DM-6576 Add new 'Pending Draft Reviews' column in the Documents Full Table - A new column has been added to the Documents Full Table to quickly identify pending draft reviews, improving document management efficiency.
    • DM-7196 Full Tables: Prevent Duplicate Downloads in a 10s timeframe with Export Button Debounce Feature - To prevent duplicate downloads, we've added a debounce feature to the export button in full tables.
    • DM-7270 Add "Review Interval" column to documents Full Table - A new "Review Interval" column has been added to the documents full table, allowing for better document review tracking.
    • DM-7322 [Document PDF] Wrap document and category name in the header of exported/viewed PDFs - Document and category names in PDF headers are now fully visible, enhancing readability.
    • TRAIN-1383 Course: Add Key ID and Document ID to the Course Documents syllabus tables
    • TRAIN-1384 Course: Add OJT Event ID column to the Course OJTs syllabus tables
    • DM-7341 [Dashboard Signatures Needed] [Reviews and Suggested Edits]Add Specific Type Labels for Annotation and Collaborative Editing
    • MIG-555 [FlatFile Configuration Migration] Update User Single Selections/User Multiple Selections to text type to avoid API issues on Flatfile tool
    • REP-511 Implement the Release Date DB column to be used as displaying of the report in the UI
    • REP-575 [Reports Settings] Improve exporting of empty reports to inform the user that "No data available for this report" instead of empty excel/csv
    • ZENQ-6877 Pre-release Support for Billing and Subscription Management Page
    • ZENQ-6874 Pre-release support for New Main Dashboard - phase 2
  • Enhanced Public API endpoints for Document Management: We've made improvements to our Public API, focusing on document management capabilities. These enhancements ensure that users can efficiently manage and access document versions and categories with the appropriate permissions.
    • ZENQ-6721 Public API - Add Category Permission on "Documents Versions Search" -
      To ensure secure access, the API now only returns document versions for categories that the token has "Read" or "Read/Write" permissions. This enhancement prevents unauthorized access to document versions.
    • ZENQ-6720 Public API - Add Category Permission on "Get List of Document Categories" - The API now restricts access to document categories based on token permissions, ensuring that only authorized categories are returned. This change enhances data security and privacy.
    • ZENQ-6680 Public API Endpoint - Documents Versions Search - A new endpoint has been introduced to allow users to search for document versions using various criteria, such as category or date range. This feature supports integration with external systems for document management.
    • ZENQ-6679 Public API Endpoint - Documents - Get List of Document Categories - We've added a new endpoint to retrieve a list of document categories, enabling users to track changes in document categories within the ZenQMS application. This feature supports better document management and integration.
    • ZENQ-6670 Public API Endpoint - Create Documents - A new endpoint has been created to allow users to create documents via the Public API. This feature includes logging changes in the Audit Trail and syncing data with legacy tables, enhancing document management capabilities.

 

Key critical and major bug fixes include:

 

  • DM-6793 Document Audit Trail UI Table shows no results if document is modified before opening Audit Trail, without being refreshed - events are tracked correctly in the database
  • DM-6945 Events visible in the Audit Trail table in UI after clicking on Cancel for a Periodic Review (workflow not launched) are missing “Periodic review cancelled“ event label
  • DM-7299 Columns selected in the complex filter are not being applied if they were not previously selected in the full table column selector
  • DM-7381 Concurrent Editing Issue: Workflow Launch by Second Author Ignores Recent Category Change
  • IM-1505 Stage Custom Fields: Loading the wrong options for Active/Retired Category versions
  • IM-1524 [Issues/Change Controls] New Account Custom Fields values not updating in previously opened records
  • AUTH-1514 Users can remove the "All Account Users" role from them using the public api endpoint
  • CCM-1900 Dashboard -> Items Past Due: Items past due because of Project Due Dates are incorrectly tagged on dashboard with "Past Stage Due Date"
  • DM-6738 PDF Export FileName Cuts off When "/" is in the Document Name
  • DM-6835 [Documents View/Edit]The app is throwing an error that all fields need to be filled even after all required ones are filled
  • DM-6909 Users assigned to a role with category permission "Can Edit Any Document in Category", are not seeing those category documents in the Full Table
  • DM-6989 Controlled copy ID included in PDC file is missing a trailing zero when copy ID is less than 10, leading to inconsistencies between the user interface and the final PDC output
  • DM-7089 Document category Key Starting # is limiting users to 6 characters when it should not
  • DM-7240 Manage Assigned Trainees: Filtering on Training Status column not working for languages different than English
  • DM-7278 If user had no title when they applied the signature and then a title is filled in, title should not appear on the applied signature (Documents, Issues, CCs)
  • DM-7287 Documents: Error is triggered when trying to remove values from non-required custom fields and after a refresh the previous value is still displayed
  • DM-7291 [Documents Full Table] Plain text custom fields are incorrectly available as a filter and column option in the full table view
  • DM-7300 Error when exporting a document with "Include ZenQMS Data Page" toggle OFF and all the options under it selected
  • DM-7329 Users with read-only permission should not be able to access draft documents via the hyperlink in the banner message on effective version OR direct URL
  • DM-7359 Users with "Can Edit any document in this category" are not able to open the document
  • DM-7376 User with Can See All Documents permission should not be allowed to open DRAFT documents via URL
  • IM-1549 Issues/Change Control/Tasks Full Tables rendering incorrect custom field columns when selecting different categories
  • MIG-448 [FlatFile Configuration Migration] Investigate and fix "Is Training Doc/AutoCreate TR" when Is Training = No and user is inserting/not inserting value for the training options
  • MIG-470 [FlatFile Configuration Migration][Template][Documents Tab][ACF] Types with options to be selected is not displayed as dropdown
  • SIGN-576 External User can bypass ZenSign authentication in a browser where a previous authentication session with a different email was open
  • SIGN-579 User title updates on already applied electronic signatures in ZenSign for Change Control and Issues
  • TM-282 [Task Links]Updating Task Asignee Response Field Erases Linked Documents Titles, keeping just the ID
  • TRAIN-1280 Empty course has training status Past Due and assigned trainees are shown as "At Risk/Past Due"
  • TRAIN-1448 Training: Trainee Records > Groups view > Training Status columns not counting records coming from OJTs in the syllabi of courses that the group is assigned to train
  • TRAIN-1463 The user is able to generate multiple request that ends up in having duplicated items under the SCORM Trainees table
  • ZENQ-6516 Tooltip Interfering with Dropdown Navigation in Change Control
  • ZENQ-6754 [UI responsiveness][Documents]Users can't upload new revision on mobile due to layout issues
  • ZENQ-6818 Settings-> Preferences page: link for downloading the app required for viewing controlled copies is broken and redirects to a page that no longer exists
  • CCM-1905 [Localization] Issues/CC/Tasks Tab > [TRANSLATE] Select your view:
  • CCM-1906 [Localization] Issues/CC/Tasks Full Table > Search
  • CCM-1907 [Localization] Open an Issue/CC > More Options
  • CCM-1908 [Localization] Issues Full Table > Filter > And/Or
  • SIGN-536 Multiple'External assignee downloaded PDF of workflow' audit trail events are generated while window remains open

 

Schedule

Due to the impact on users of this release and the time it will take to perform this update, we will apply the updates to sandbox and production separately. Both will occur outside top hours, to provide as little interruption to normal operations as possible.

 

Sandbox

Date: 31-JUL-2025

Time:  12:00 PM UTC / 8:00 AM EDT

Downtime: No downtime

 

Production

Date: 01-AUG-2025

Time:  9:00 AM UTC / 05:00 AM EDT 

Downtime: No downtime

 

Impact

This release impacts users across the following modules: Change Controls, Documents, Insights, Issues, Tasks, Training, Public API, Reports, and ZenSign. All module dashboards have been updated with a new user interface, which may affect users’ familiarity with these pages. Additionally, if your procedures or training materials reference these dashboards, updates may be required.

 

Documentation

This release is being managed through change control 301-107. You can download a copy of the first stages of the system release record, including the requirements and testing traceability matrix for release notes here 30.0.0 System Release Record 301-107 Release Notes. An entire release record will be available for review after the release is completed, in the auditor share account.

We expect no downtime.

 

Version Details

ZenQMS comprises a microservice architecture that breaks up large functions into smaller services. This reduces risk in the development and release process. As such this flagship release version is actually composed of the releases of the individual services components. It is entirely possible for a component service to not change versions in a release cycle even if other components do. Here is the summary for this release.

 

ZenQMS Release 30.0.0 contains the following “FixVersions”. We use FixVersion as an internal versioning scheme for our modules/services and maintain them in Jira.

"AUTH 5.17","CCM 6.2","DM 3.15", "IM 7.8","INSIGHT 2.6","MIG 4.10", "REP 4.3", "TM 6.3", "TRAIN 3.10", "ZENQ 26.10", "ZenSign 2.1", "ZenSign 2.0"

 

Updated Modules

  • Audit Trail
  • Documents
  • Import/Export Data service
  • Insights
  • Public API
  • Reports
  • Training
  • ZenSign
  • Account Backup
  • Administration
  • Audits
  • Change Control
  • Daily Summary emails
  • Issues
  • Tasks

Unchanged Modules

  • PDF generation service
  • Login/Authorization
  • Notifications emails

 

Important Notes

  • This announcement plus the banner announcement in the application to ALL users is our formal announcement for the release.
  • You will be able to log into test2.zenqms.com and try out the changes from 30.0.0 release ahead of 01-AUG-2025. This environment was refreshed on 07-APR-2025 with your latest production data and will be available for you to login starting 30-JUN-2025.
  • To minimize disruption, we scheduled the 30.0.0 release deployment to sandbox and production separately. Both will occur outside top hours, to provide as little interruption to normal operations as possible. We expect zero downtime. This release introduces primarily new features and improvements that should not significantly impact your daily operations. You can immediately access the new functionality for testing at test2.zenqms.com. We encourage you to prioritize testing the Option to update the Review Date during Minor Upversion, Ability to Unretire a Document Category as they may have the most direct impact on your current workflows, as well as all the UI updates across dashboards. Features such as the new Public API endpoints, ZenSign, new set of Reports can be explored at your convenience. We will be logging an internal deviation to document this exception to our release requirements.
  • An updated copy of the UAT template will be available in your Auditor Share Account.
  • Deployment (as always) is handled by the ZenQMS team.
Was this article helpful?
2 out of 2 found this helpful
Have more questions? Submit a request

Comments

0 comments

Please sign in to leave a comment.