We are pleased to announce Major Release 2019.1.  Please click this link to download the  2019.1 Requirements & Traceability Matrix -- Summary Release Notes (v.01) referenced below.

The release includes several major enhancements to the ZenQMS platform including Validation documentation and delivery. Some highlights (in order of significance/impact):

  • Change Control:
    • Create a change control process to match your general SOP or create several change control types that serve multiple processes.
    • The new module flexibility is due to a new platform; this platform begins to deliver  critical features that will be rolled out to the other modules throughout the remainder of this year and next.
  • Tasks:
    • Create tasks to assign users to complete actions in reference to the specific Change Control process that would be outside of the category configuration.
    • Initially, tasks will be captive to Change Controls, but will eventually serve multiple modules and allow for stand alone tasks as well.
  • New features that will serve only Change Control / Tasks modules (as noted above some of these will be extended to other modules in future releases):
    • Notifications: We are implementing a new approach to Notification management for item specific events and daily summary/ escalations.  
    • Account Custom Fields: Custom fields that apply to the whole application.
    • Module Management: Administrators can decide what modules appear for your users.
    • Settings: We will be transitioning all user and account admin functions to this area.
    • PDF export flexibility: Change Control and Tasks modules will rely on a brand new and faster PDF export engine that supports greater flexibility in export settings for watermark and header text, first/second page format, etc...
    • Improved dashboards that include column customization and additional data export functions.
  • Upgraded BI Reports/Dashboard platform
    • Significant update that allows for easier report creation and sharing across your enterprise.
    • Ability to schedule emails for specific reports.
    • Will allow ZenQMS to roll out new reports and dashboards for clients later this summer/fall.
  • General:
    • Updates to the file conversion utility (Aspose) to address bugs and add new functionality.
    • There are a number of minor improvements and bug fixes worth reviewing in the detailed list below.
    • We will be setting inactivity session time out to 15 minutes (it was 30 minutes until now). 
  • Existing Documents/Audits/Issues/Training functionality was very little affected with this release.  That should help with your review/assessment of this release.

Validation/Deployment Details

  • This announcement plus the banner announcement in the application to ALL users is our formal announcement for the release.  
  • We plan to deploy on 30-June-2019 at 9pm EST. If this causes any issues for your team, please email help@zenqms.com as soon as possible -- we expect some slowness or possible down-time during deployment.    
  • Deployment (as always) is handled by the ZenQMS team-- so don't worry!
  • About those Xs in the release notes title: clients have asked us to include the source code build ID in these release notes. We will do so post deployment-- this will match the version ID in production.
  • All changes will be available for you to access and test at test.zenqms.com immediately The data in test.zenqms.com was reset to match production data in late April 2019. If you have any problems logging in, please email help@zenqms.com.  
  • Helpdesk will release articles and videos for training purposes over the next few weeks-- we will update this article with links as appropriate.
  • This release is being managed under change control #34075 and a full set of validation documents will be published and added to the auditor share as they are approved.  

Validation Documents *Please Read*

  • We continue to evolve our approach to documentation in our commitment to exceed regulatory expectations. More importantly our goal is to make it easier for clients to understand our documentation.
  • For this release, instead of a general list of improvements/bugs, we will include an attached excel file that will summarize all of the changes. Here is what you will see:

    • We are exclusively focused on the User Stories that drive our development process and the specific requirements needed to deliver them. Stories are verified through testing; test cases are connected directly to them.
    • In our release notes, we connect all the dots to give you clear traceability and continuity.  
    • For each story, we are sharing a Validation Risk Assessment protocol with clients for the first time.  
    • The changes are based on a year long review of our documentation as well as feedback from clients, consultants, and our own internal audits/reviews.  
  • These release notes will be updated potentially prior to the release of the OQ/OQ in the event that test cases are created/updated.  

 

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