Released to Sandboxes
The following changes are available October 24, 2022 in your sandbox and will be released to production on November 23rd, 2022:
Events: New user interface and new features
With Qualio Events, you have the ability to manage your quality event process, from complaints and CAPA’s to deviations and change control. Within Qualio we have updated our Events User Interface (UI) to enhance your experience. The following pages now have the new UI:
Products list and adding Products
Root Causes list and adding Root Causes
If you are an existing user of Events, note the Events menu will now be a single click to allow you to open the events list view, removing the existing submenu.
We’re also excited to announce the following updates:
New Events Listing Page With Enhanced Filtering
Improved Filtering of Events and Tasks
Find Events listing to specific Products
Find Events linked to specific Root Causes
Added Task Filtering
Filter tasks by Event type, status, user and if overdue
Find overdue tasks for a specific user
Display how long all events and tasks have been overdue
Filtering and sorting saved in URL, bookmark settings or share a link to other users to show the same data.
Better tag management - Editing of tags on closed Quality Events
Product & Root Cause Enhancements
Changes limited to Quality Users only
List up to a hundred product or root causes
Sort products or root causes by number of open events
Link to Quality Events related to product or root cause
Better Quality Event Comments
Attachments on Quality Event Comments
Comments visible on closed tasks
To learn more about these updates, see our help article here.
Validation for Events
Qualio has completed the general validation, and the pack is linked here for your review. You are welcome to generate test scripts from this documentation if you prefer, but we have tested these features on your behalf.
User management: New Admin Permission and Admin Settings Page
Qualio’s new admin functionality enables organizations to designate admin permissions to any role whether they are a Quality, Normal or Basic user. This is particularly helpful if you want to grant admin access to individuals who work outside your quality department as it allows you to maintain the confidentiality of sensitive information while ensuring people in e.g. IT, have the access they need.
As we roll this out to you, note that all Quality users will maintain their admin rights, but can later be removed as it will now be decoupled for the Quality role. All admins can then manage the admin permissions of other users.
All changes made will be captured and reflected in the company’s Audit Trail.
With the new admin functionality all user and group information can now be accessed and edited under a new user / group menu item in the Admin Settings page. Admins will be able to change permissions and settings for all users within their company from here.
See our help center article to learn more.
Released to Production
The following changes will soon be available in your sandbox and will begin to be released to production in a phased manner on November 23, 2022:
Design Controls: Attachments
With attachments, Qualio enables medical device teams to easily attach drawing, design, and test result files to each design element or test, creating a single source of truth for your product and quality teams.
Add attachments up to 100MB to requirements, test cases, and results:
Requirements and Test Cases: Up to 10 attachments per requirement or test case, 500MB max
Test Results: Up to 5 attachments per test results, 200MB max
Attachments are zipped and exported within reach review created
Take a look at our Help Center article here.
Document Templates: New user interface
Document Templates have been moved under the Document on the main Navigation. This area is only accessible to Quality Users. The user interface has been refreshed for both the list of templates and the templates themselves.
Additionally, we have included two valuable updates:
The periodic review period has now been extended from 36 months to 86 months. This will be also applicable to Document Properties
Template prefixes can now contain numeric values
To Learn more, see our help center article here.
New Integration: Zephyr Scale
If you currently use Zephyr Scale and would like to integrate with Qualio - now is the time!
With our newest integration you can seamlessly sync your test cases and test results directly into Qualio Design Controls when you use Zephyr as a test case add-on within Jira and have complete traceability of your testing activity.
Additional information for your team:
Validation: Updated approach to validation
Qualio is excited to announce that we’re implementing an industry-leading computer software assurance (CSA) approach to our Validation Package. To learn more, join our Validation webinar tomorrow, 10/25 at 11:30AM ET - sign up here.
You can read more about the updates in our documentation below:
Our Approach to Validation (October 2022)
A detailed review of Qualio’s new approach to validation
Computer Software Assurance (CSA) Transition Tips (October 2022)
How to bring your Qualio validation activity in line with industry best practice
You must be logged in to Qualio to review this article
Complete guide to computerized system compliance in 2022 (September 2022)
New Editor Update: Would you like early access to the new Document Editor?
We are continuing to progress development on our new document editor, which will give an enhanced and modern editing and collaboration experience, with inline comments, suggested changes and much more.
We would like to invite a number of customers to get early access to the new editor within their production account ahead of the full release to all customers.
If you are interested please add your details here.