In February 2024, the Qualio product team hosted a webinar about the new features being released in the first Launch Train of 2024. In this webinar, our Product Managers discussed the new features that are being released to production accounts on March 14, 2024, and hosted a Q&A session for attendees to ask questions.
View the recorded webinar below or jump to the Q&A.
Links shared during the Webinar
We’d love to hear about your experience with our Launch Trains!
Questions and Answers from the Webinar
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Analytics Improvements
When will the changes to analytics be implemented in the sandbox?
The Analytics improvements were enabled in all sandbox accounts during the validation period (beginning February 13, 2024).
Do fields from event form steps feed into Analytics?
We are working on adding form responses to Analytics, but this is not currently available.
Change Control Search
Does the search only work for open Change Controls?
The Change Control search works in tandem with the filter for open/closed CCs.
Document Change Requests
If you use a Document Change Request (DCR), do you also have to complete a Change Control? Why are they managed separately?
Yes, individual document changes will still need to be captured as you normally would while editing a document. We will continue to invest in our Change Request functionality, including more document-specific management at the DCR level. However, we do think it is important to keep document-specific CCs distinct from DCR content, but we will look into more closely connecting the content in a future release.
Are ongoing DCRs visible on the owner’s Dashboard?
Yes, DCRs will appear as a notification on the dashboard for the request owner.
Can a DCR be edited before it’s approved? Can it be canceled if it was created by mistake?
Yes, a DCR can be edited (text sections and adding/removing documents) or deleted while it’s in Draft. If the DCR is In Progress, it cannot be edited or deleted.
Can a DCR be adjusted after it’s been approved?
No, once approved, no changes can be made.
Is the DCR template editable/can it be changed?
No, this template is not editable at this time.
Will Change Controls that had been created in the past disappear?
No, all individual Change Controls within documents will remain the same, whether created before or after this release.
Can documents be added to a DCR regardless of who the owner is?
Yes, any existing documents can be added to a DCR, regardless of the owner or document status.
Is there a word limit for any fields in the DCR template?
No, there are no text limitations for DCRs.
Does the DCR have an approval process?
Not yet - this is currently under development!
Can a DCR include anything other than documents? For example, can we associate tasks to be completed as part of the change in the DCR?
Not at this time, but we’re currently looking into this.
Does the DCR act as a bulk approval for all documents added to it? Can the DCR update multiple documents at once?
No, the documents still go through their individual review and approval process.
Event 'Related' Fields & Escalations
Similar to the Related Events field, will the Related Documents field work both ways? For example, does a document show any related events while viewing the document?
Not as part of this release, but this is something we’re looking into.
Is the properties tab visible from the step editing screen? It would be helpful to see any linked events while completing a step.
Not at this time, but this is great feedback for future enhancements!
Will the event escalation be captured in the audit trail?
The audit trail will display that the new event was created but does not show as an escalation.
When escalating an event to another event type, does the original event close or does it have to be done manually?
The only change to the original event is adding the link; you would still need to close the original event manually.
Forms for Events
Is it possible to add checkboxes to forms?
Not with the initial release. You can use dropdowns to add similar questions, but Checkboxes are scheduled to be added as part of our next launch train.
What’s the difference between a form and a templated content step?
Forms allow you to have restricted field values (dates, predefined values, numbers, etc). This makes it easier to complete and easier to analyze afterward. Content steps are free text fields that act similarly to a document.
How many fields can I add to a form step?
There are no limits on the number of fields. Currently, forms support single-line text, rich paragraph text, date, numeric, yes/no, attachment, and dropdown field types.
Is there any if-then logic built into form steps? For example, if the issue source is XYZ then only show specific questions.
Not at this time.
How can I export the details I’ve entered into the form in an event?
From the main Events list page, the export option is behind the 3-dot (⋮) menu next to the Owner filter. This export will include form details for all the event types displayed on the page.
OneDrive Integration
Is there a way to know if there is a change outside of Qualio, or do you always have to click “fetch latest?”
There is no indication in Qualio that the source file has changed. This can be found by opening the original using ‘View in OneDrive’ and comparing the time/date of changes against when updates were last fetched in Qualio. We only pull in an updated source file when you click 'Fetch Latest'.
If I click “fetch latest” but don’t send the document for approval, will the version remain the same in Qualio?
Yes, that is correct. Version control in Qualio remains the same.
Is the OneDrive integration a validated feature?
Yes, the integration is part of our validation pack. The reference is test DOCS-1041.
Will editing a document in Qualio impact the document in OneDrive?
No
Will fetching the latest OneDrive version cause a new revision to be created in Qualio?
You can only sync an updated file when the Qualio document is in Draft, once submitted for review or approval the file is essentially locked at that point and you cannot sync updates. To make a change at this point you need to revert to draft, thus maintaining the same revision/audits we have today.
Is there traceability when there is a change to a file in OneDrive?
No, as the owner of the document in Qualio you have to pull in the latest version of the document from OneDrive.
Is it possible to upload OneDrive/SharePoint documents into an Event?
Not at this time.
Can you create OneDrive files to match current Qualio documents (essentially an export) to allow the team to update editing outside of Qualio?
Documents would need to be created in SharePoint, then a new draft created in Qualio to add that document to, to reflect the latest OneDrive/SharePoint document.
If someone has access to OneDrive file but does not have access to Qualio, can they still make revisions to an approved document that are reflected in Qualio?
Any changes made to a file in OneDrive will not be reflected in the Qualio document until the latest version has been fetched and then sent for approval.
Does the file in OneDrive need the same template in Qualio?
No, the Qualio template structure will not apply to files imported from OneDrive. Only the template properties in Qualio will be applicable (tags, training availability, review period, etc.)
How does the audit trail work when documents are linked via OneDrive? Will changes made in OneDrive populate in the audit trail export in Qualio?
You can only sync an updated file when the Qualio document is in Draft, once submitted for review or approval the file is essentially locked at that point and you cannot sync updates. To make a change at this point you need to revert to draft, thus maintaining the same revision / audits we have today. We do not track / audit changes made in OneDrive.
Does the SharePoint/OneDrive integration work with Excel?
Excel is not supported at this time.
Is all the formatting of external files in the OneDrive compatible with Qualio?
We do our best to maintain all original formatting, but when converting between formats there is always a chance that some formatting will be changed. We encourage you to lookover the converted document in draft before submitting it for review.
Are there any other integrations from different platforms available?
We’re currently working on an equivalent for Google Drive (please add your interest here). If you use other tools (Box, Dropbox, etc.), please contact your CSM and they will relay your feedback to our Product team for potential future development.
You can learn about our other integrations here.
Is there a way users can use document templates outside of Qualio so the formatting of external documents can be the same?
It's not possible to export from the template screen today but you could create a blank document using the template and export that as a PDF. The ability to lock down content as unchangeable is one of the main advantages to building your docs in Qualio.
Supplier Linking
Can you see/access the events linked to a Supplier by checking that Supplier’s information?
Not as part of this release, but we’re looking into it.
User Management
Will the user search be able to be exported to Excel?
Not at this time.
General Q&A
Are there any plans to release change control for templates?
Adding change control for templates is something we are aware of and are continuing to research.
Do any of the launch trains for 2024 include updates/improvements to the Suppliers module in Qualio?
There are no current plans for updates/improvements specifically to the supplier module
Can the header or footer of a Qualio document be edited? For example, adding batch record information.
If referring to a controlled or uncontrolled export, the header and footers are not editable.
When will the changes discussed in this webinar be released?
The changes are available in your Sandbox since February 13th and will be in your production instance on Thursday, March 14, 2024. You can see our entire launch train schedule for 2024 here.
Are there any plans to be able to search the Document Workspace by the document’s owner, the type, and the creation date?
This search functionality is already available in the Workspace and Library. See some examples of search strings in our Help Center.
Is it possible to duplicate a template to create a new one based on an existing template?
It is not possible to duplicate templates at this time.
To implement new modules/features, would I need to validate the Part11/Annex 11 compliance and user set-ups specifically for these new features?
The Qualio platform is Part 11/Annex 11 compliant, and this compliance extends to all available features. Please see our Part 11 Assessment and Annex 11 Assessment.
Are there any word limits in any fields while writing Change Controls?
There are no text limits within Change Controls.
Where can I find the version number for any release?
You can find all version numbers and their associated release dates in our Product Changes log (accessible via the gear icon at the top of your page).
Are there default event templates suggested by Qualio, or does everything have to be created and customized by the customer? Examples would be CAPA, NCs, Audits, AEs, etc.
We are looking to include these in the future.