Qualio's August Launch Train delivers a range of enhancements focused on event usability, updates to training assessments, improved exporting features, and additional Dashboard entries. Explore the exciting changes below!
August '25 Launch Train Timeline
EVENT | DATE |
30-Day Evaluation Period Begins (Sandbox) | August 12, 2025 |
Customer Webinar | August 14, 2025 |
Released to Production | September 11, 2025 |
Events
Challenge: Events and associated tasks occasionally need additions or updates after they've been completed, and managing dates can be overly complicated when calculating the number of days for these activities.
Solution: We've added the flexibility to reopen tasks and a more intuitive date selector to help manage all the activities that could be required for the event.
Event Lifecycle Management
If a task has been closed and requires updates or other changes, it can now be reopened. When reopening, an electronic signature is required along with the rationale for why the task is being reopened.
Enhanced Date Controls
Due dates are now selected via a calendar instead of a number of days.
Additionally, step dates can no longer extend beyond the overall event due date.
Event Closure Tracking
The Resolved Date has now been added to the main Events dashboard to aid in reporting and improve lifecycle visibility.
Availability: Available to all Qualio users with event permissions enabled.
Validation: This change has resulted in an update to the Qualio Automated Validation Pack. Please check the updated documentation and test evidence: Validation Resources.
Learn More: Create and Manage Events
Training
Challenge: Completing training is difficult when you're unsure which answers are incorrect during assessments.
Solution: We've introduced indicators that let you know which answer(s) are incorrect during training assessments.
Training Assessments
Incorrect answers are now highlighted in red, in addition to the top banner that indicates how many answers are incorrect.
Training Management
We've added the option to export Training Plans to Excel to more easily manage training across teams.
Availability: The training assessment updates are available to all Qualio users. The Training Plans update is available to all Quality users.
Validation: This change has resulted in an update to the Qualio Automated Validation Pack. Please check the updated documentation and test evidence: Validation Resources.
Learn More: How to Complete Training
Dashboard
Challenge: There was a lack of visibility into Qualio's Supplier and Design Controls features.
Solution: Additional Dashboard entries have been added.
Entries for Suppliers and Design Control Reviews have been added to the Dashboard. These can now also be found in the Filter selections for easy navigation.
Availability: Available to all users who have Suppliers and/or Design Controls permissions enabled.
Validation: This change has resulted in an update to the Qualio Automated Validation Pack. Please check the updated documentation and test evidence: Validation Resources.
Documents
Challenge: Headers/footers of documents in the original file format (uploaded) may sometimes be cut off due to differing margins.
Solution: Automatic resizing ensures that headers and footers are always visible.
When uploading a document using the original file format, you'll now see a "Content shrinking" option after clicking Export.
Availability: Available to all Qualio users.
Validation: This change has resulted in an update to the Qualio Automated Validation Pack. Please check the updated documentation and test evidence: Validation Resources.
General Q&A
Is the LLM that you are using built on a "generic" LLM such as ChatGTP or Gemini?
The tool is built on a private instance of Claude by Anthropic which sits within Qualio's infrastructure.
Can you add the Event types of dates/calendar functionalities to Suppliers, including the addition of Supplier Notifications?
We appreciate the feedback, and will look at expanding the date and notification functionality to other areas of Qualio in the future.
Currently Qualio does not allow specifying an order for approval signatures (who signs first, second...) for our documents and events. Can it be updated to allow us to specify a signing order? It would also be very useful the events module can be updated to allow suggestions to content (as can be done with documents).
Neither specifying an approval order or suggestions in events are on the short term roadmap, but we can evaluate and hopefully include in a future release.
If a Token is kind of a "User" will it count against your number of licenses?
API tokens will not count towards the total number of user licenses.
Is it possible to ask the system to only fetch data among documents with specific tags? Let's say a company has several sites and have tagged documents with what tag they belong to, then it would be optimal to be able to ask the system to only do the gap analysis for a specific site.
We do not currently use tags to determine which documents are automatically mapped to your controls, but you can manually associate any document and Compliance Intelligence will run a gap analysis on them.
Can an audit trail report be generated for when gap analysis are done - you can see what was checked and when?
You can access the history of all gaps which includes the date/time and reasons for dismissal/resolution.
Do you have an AATB framework?
No, we do not have this framework at the moment, I will add it to our backlog for assessment. There is always the option to create a custom framework.
Is there any plan to include text editing abilities in the Tasks? (i.e. The ability to add hard returns to separate text lines)
The new Compliance Intelligence tasks include updated text editing capabilities that we hope to extend to event tasks in the future.
Is there an option to keep a due date in a calendar format or in a number of days? I mean both options availability.
Event templates will still be configured using a relative number of days. That calculation will populate the default due date for events, but moving forward all individual event and task due dates will be set using the calendar picker.
Does the AI integrate the WHO TRSs and the general chapters from the recognized pharmacopoeia? It would be great for us in Pharma.
Unfortunately, not at this time but that looks like a really interesting area to explore.
Does the AI function with other languages other than English?
At this time, we have been working in English only.
How often are you checking for updates to regulations (e.g., 21 FDA regulations are updated regularly)? Do you have EU IVDR regulations in Qualio?
Our internal SME's who manage the frameworks are continuously checking for updates.
Can due date changes require a sign-off? You are essentially giving your event an extension without opportunity for approval.
This update does not include approvals or sign offs on due date changes.
Any framework for MDR or IVDR compliance?
Both MDR and IVDR are on our roadmap of frameworks to add to the offering.
Will this be in our Sandbox, so that we can evaluate the intrinsic value to our company prior to investing in the module?
If you want to do an assessment, please contact your CSM and we can see what the best approach is for you.
On reopening event tasks - ideally the user should have to put in a justification and quality users being able to approve or reject.
Reopening a task does require a reason or justification for reopening. That data is stored on the task and in the audit trail. However, there is no approval process associated with this behavior.
Will the ability to change default filters be included? Right now when I go to the events area it always defaults to "Open" and "Imported", but I would rather have no default filters on.
This release includes keeping filters 'sticky' during a single Qualio session. We are exploring how to expand that functionality to set default filters every time you log into Qualio.
Will this CI be part of current subscriptions or will this be separate subscription?
CI will be an additional subscription, and if you want to know more, please contact your CSM.
How often are you checking for updates to regulations? Do you have EU IVDR regulations in Qualio?
Our internal SME's are continuously monitoring for updates. EU IVDR is on our roadmap for Frameworks to add to the offering.
Can procedures in draft be checked for gaps or just the current effective version?
Version lower that 1.0 can be manually added and assessed. Once greater that 1.0 only major approved versions will be assessed.
How will pre-built frameworks and controls be updated as the Regs and Standards change?
An update framework will be released as a new framework reusing controls from the control library where possible.