In June 2024, the Qualio product team hosted a webinar about the new features being released in the second Launch Train of 2024. In this webinar, our Product Managers discussed the new features that are being released to production accounts on June 13, 2024, and hosted a Q&A session for attendees to ask questions.
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View the recorded webinar below or jump to the Q&A.
We’d love to hear about your experience with our Launch Trains!
Questions and Answers from the Webinar
Quick Navigation by Feature
Document Change Requests (DCR)
Is Manage Order changing the Current owner of the effective document or the new draft document created as part of the Change Request?
The owner of the draft document is changed once the Change Request moves to the In Progress status.
Do the DCR changes (description of change, reason for change, impact assessment) populate to the change control of the individual document(s)?
No, the CCs for the individual documents are specific to the changes made to each document. Each document maintains a reference to the overarching Change Request, and you can view this and its details from within the document’s screen.
Is this change control feature for bulk documents only or for every document change? Is the CC tab no longer there?
Each individual document still has its CC for each version change of that document
Can approvers of a DCR be the same person who initiates it, or does it need to be someone else?
Yes, the approver can be the same as the owner/initiator of the Change Request.
Will it be possible to create or link different change requests to one document in the future? Currently, it is not possible to have more than 1 change request for a document, even though we have different sources that can lead to a change request.
This will not be possible as you can only have a single document draft open at a time. You would either have to group the change requests or wait until one change is completed before proceeding with the next.
Can an approver of the DCR revise a DCR field directly, or can only the DCR owner/initiator revise a DCR field?
The owner of the Change Request would need to make the revisions to the content.
Is the related document list accessible outside of the change request?
At this time it is only available in the change request. However, we are looking at introducing this to other areas of the application in the future.
Are reviewers able to see/review the related documents list?
Change Request approvers can see the final set of documents included in the request but do not see the list of related documents.
What is the change request workflow? Does it incorporate the full change management workflow that can include change request - approval of request -> and change order (implement changes, eg. engineering changes) and final approval to close the change?
The Change Request workflow includes a required approval of the request. All requested changes are made on the individual documents, with independent change controls, while the Change Request acts as a way to monitor progress. The Change Request can optionally be set as the final approver of all the documents, acting as the final check before closure. Still, there is no additional approval flow when closing out the Change Request. You can see the full DCR process outlined here.
How many levels down does the related documents list go?
Currently, related documents only look at the first level down, specifically at links directly on the selected document. We are exploring ways to enhance this feature in the future to span more levels of the relationships and give even more refined suggestions.
Does bulk approval mean or include bulk release?
It means bulk release; upon the Change Request's closure, all documents will transition to approved status.
Is that bulk approval shown on the individual documents?
Yes, you can view the associated change request on each document
Our company currently makes document changes using a change control event. Will I need to create a document change request as well?
Without knowing the full details of how you use events for this, I think you would use one or the other. As such, you would transition from using the event workflow to this capability.
If it was discovered we needed to edit the 3 sections of the DCR page once a document was added or removed, is it possible to edit those sections after approval?
It is not currently possible to edit the 3 text sections on the Change Request, but we are exploring this as a future feature enhancement.
Can we custom-fill the 3 sections (description of change, reason for change, impact assessment) with guidance text for users separate from how the Qualio Change Control tab is set up for individual documents? Or are these 3 fields set up the same, whether it's a bulk change request or a document change control?
Currently we cannot pre-fill the sections on the Change request. The document change control template is separate and behaves as it always has, independent of the Change Request
Is it (or will it be) possible to include changes to document/event templates in one of these document change requests (for example, a new template becomes available when the governing SOP is revised)?
Change to document/event template cannot be added to Document Change Requests, but is something we are looking at adding in the future.
Can an event be linked to a DCR? Or is there another way to assign actions to a DCR?
A DCR can be linked to an event via the new Qualio Resource form fields; however, events can not be added to a DCR. We are currently working on updates to allow adding smart links to DCRs and are exploring how to include Events directly on the DCR in the future.
How does the bulk approvals work if there are multiple changes for the same document? For example, v2 of the document gets approved but is held at bulk approval.
The document version is held in a "For approval" status until the associated Change Request is closed (as long as bulk approvals are enabled on that Change Request). New drafts of that document can not be created unless the DCR is closed or the document is removed from the pending bulk approval.
NOTE: A document can only be in one Change Request at a time.
If the document itself has been finalized/approved/effective (but bulk change request 1 is still open), can the document be added to a second change request if it's noticed a separate change is required?
As long as the Bulk Change Request is still open, the document will be held in a For Approval status, preventing it from being added to a second change request.
Do revisions require initiating a change request, or can a new draft be prepared with an individual change control following the current process?
A new draft can be created as you normally would outside of the new change request flow.
Are change requests specific to documents? Do I still need a Quality Event template for change controls for actual changes, like equipment changes?
Currently, the change request is only for documents, but we are exploring ways to expand to other areas in the future.
If we have additional actions from a DCR impact assessment, how do we assign that action.
Right now, there is no way to do this via DCR.
Are there plans to allow users to suggest changes for the future on live approved/effective documents, and then when the document goes to change control, they can be added easily (i.e., non-urgent updates/suggestions for updates could be ‘held’ on the system)?
This is great feedback. We don't currently have plans for it, but we could look at exploring it in the future.
Are there plans to add tasks to bulk change requests that don't involve document changes in Qualio? Our current change management process allows for other actions to be captured in changes.
We are looking into that. For example, being able to add changes/actions that go beyond documents, i.e., design changes.
Events
When will the section, radio, and checkboxes be available?
The form enhancements are in sandbox accounts now and will be released to production after the validation period ends on June 13.
Is the revision on the approved event form Type captured in audit trail/version history?
Form steps can be reverted back to draft after approval, which allows revisions to previously entered answers. This action is captured in the Audit Trail as an "Event Step Reverted" action.
Are the "form" sections still lacking the ability to have a revision history? For example, if I fill out and approve a form but then go back in and revise it, can I see the first version and approvals (like how other sections have Ver 1.0, 2.0, etc., if revised)?
There is currently no way to view a revision history of forms, but this is something we are looking to include in the future.
Event forms currently do not allow suggestions/comments in the review cycle like content steps. Is there a plan to allow in-line review similar to other modules?
We are not currently working on this, but is something we are looking at adding in the future.
Can we capture the event title rather than the first line of the form when we send it for review/approval?
This is great feedback and something we hope to include as part of our upcoming Notifications improvements.
Can you export the information entered within Event forms?
You can export individual events as a PDF from the event detail page. You can export one or more events as an Excel or PDF document from the Events list page. When you export an event, any forms will be exported with the event.
Would you consider adding the option to combine data mineable fields into the current content steps for Events?
We have looked at this and it's an improvement we would consider for the future.
Could you set up the forms so that certain sections do not become data mineable? E.g., data-rich paragraphs where the data may not be beneficial to export to Excel automatically.
Currently, all questions are exported, but it is a great suggestion to provide the ability to exclude certain questions or form field types from exports.
If we use the form function as you described (e.g., for CAPAs) the example looks like we could capture text for investigation, tables, and radio buttons. Is there a limit to how much data can be added to a rich data paragraph? Will this cause issues when you try to download the Excel afterward? I believe this issue was there before, where we had to limit the number of characters in a title for it to download correctly.
There is no theoretical limit, but it is worth remembering that this content gets exported to a single cell in Excel that does not have formatting and a large viewing area.
For Quality Events, will there be a future enhancement to assign different sections/steps to different owners? For example, assigning investigation sections to Manufacturing personnel and the product impact statement to Quality personnel rather than just reassigning ownership back and forth.
This is great feedback and something we are actively exploring as a future update.
Can form widths be adjusted?
Thank you for the feedback, this is something we can look into in the future.
Artificial Intelligence (AI)
How will the use of AI still maintain confidentiality and protect IP?
We maintain our own private, secure models, and data does not leave our private network. We also do not train models on your data. More information will be shared as this functionality moves to beta for early adopters.
Templates
When will you release change control for templates in Events and Documents?
We are exploring options on how to best implement change controls for templates, but have no committed timeline.
Notifications
I assume this notification allows for fewer emails. Right now, the amount of emails is crazy, and I think my staff ignores them because they get inundated every time an update is made.
Yes, allowing users to set their notification preferences is a key part of this, and you will be able to choose not to receive certain notifications via email.
I noticed the notifications are centered around action items *you* are responsible. Does the scope of the notifications also include general updates? For example, "Person A has completed Review for Document XYZ"
Right now they are task-based, but we could add a more general feed in future iterations.
Are Supplier notifications going to be included? Right now, we have to manually let users know that a supplier has been sent for approval, and it’s very clunky.
Yes, additional notification types, especially for Suppliers, is on our roadmap. More news on the delivery timeframe soon.
After a document review has been completed, how does the software provide the owner some sort of prompt informing them the reviews are complete (i.e., email, shift document back to owner's dashboard)?
When all reviewers have finished their review on an individual document, the owner gets an email notification, there is no dashboard or status update.
Beta Program
For the beta program, would we be able to switch to the standard view if needed? I'd be interested in participating, but having unreleased features live may cause issues in the event of an audit.
Any beta feature can be enabled or disabled if needed.
