Qualio Design Controls unites your team’s systems in your QMS, making Qualio the single source of truth for all of your product development activities. Design Controls is built on ISO 14971, in harmony with ISO 13485 and CFR 820. The platform surfaces quality and safety impacts and produces output documentation in one click, so your medical device or SaMD team can focus on building great products.
Design Controls helps your team to
organize your work into a clear structure
manage changes in a controlled way
identify issues quickly to focus your efforts
and generate standard documentation automatically.
Access & Permissions
Request access via Support, this is given on a per-user basis. Qualio can only grant access to users after they have accepted their invite to Qualio.
When raising a request please confirm which user role your team members need.
Only Quality and Normal users can be given the Design Controls permission. All users given the permission can create and manage products, approve/reject reviews. All activity will be recorded in Qualio.
Learn more about Design Controls access and permissions here.
Create and Configure a Product
Design Controls uses the model displayed below to enable customers to develop, verify and validate product requirements. It allows up to three levels of requirements with v&v test cases where applicable. The labels can be customized.
Migrate Requirements and Risks into Design Controls
If you’ve already documented product requirements and risks outside of Qualio, you’ll need to migrate that documentation into Design Controls. To help prepare for this manual process, here are some tips and guidance.
If you have already documented requirements in a spreadsheet format you can import your requirements, tests and risks into Qualio from the Integrations & Imports page. The format mapping used will be shown onscreen. Some cells you use may need to be condensed, while some cells may need to be divided. Title and description are the key fields, you then import data into one of the different sections based on your policies.
We have found that some customers have merged processes around Hazard Analysis and FMEA. These will also need to be separated when you input risks into Qualio Design Controls. This separation may also require organizations to update their associated risk procedures.
Linking to External Evidence
When creating a requirement or a test case that needs to reference relevant evidence outside of Design Controls, you can
use '@' and type ahead to create a smartlink that will reference a Qualio Document or other source outside of Design Controls. The smartlink always takes you to the most recent version.
use the attachment box to upload files
FAQ
Do we need to validate Design Controls before we can use it or grant access to users?
Yes. Customers should validate Design Controls before using Design Controls to create requirements, risks etc.. Tip: Use your sandbox for validation activities and the Validation Support tools Qualio provides for a “least burdensome approach”.Will Basic users have access to Design Controls in the future?
That is not on the roadmap, nor advised for that level of user. Basic users can initiate an Event that may be related to a Requirement or Risk in Design Controls.Is there a way to assign a priority to a requirement?
Not currently, but a great suggestion. We will submit that suggestion to our ProductBoard.
Can Design Controls track two overlapping projects for a software system that may need to incorporate patches on a frequent basis? (In other words, maintain requirements for different versions linked to a correct project.)
Design Controls does not support requirements overlapping multiple products. However, if the requirements are in Jira, the Jira project(s) can feed multiple products in Qualio. With that said, the same version of a requirement will display in each product.
Does the Risk Management Matrix take into consideration P1 & P2 as defined in ISO 14971: 2019 & ISO?
Design Controls does not currently support the optional P1 & P2 approach for determining probability outlined in Annex 3 but our Product team is investigating.
How does Qualio handle the quality records created when manufacturing products?
Manufacturing records (e.g. DHRs, inspection records) should be documented in the Documents area of Qualio and can subsequently be hyperlinked in Design Controls for reference to certain design elements if/where applicable.
Can CAD format files be attached?
Yes. However, there is a known limitation with CAD files where the internal references/links break when opened from a source other than where they were saved.
What does the interaction between regular documents and e.g. FMEA object look like? Can one link to the other similarly as with regular documents linking to one another?
FMEA objects can link to design elements only (i.e. needs / inputs / outputs / verification / validation elements). Design elements can link to documents via attachments/hyperlinks.Can Design Controls generate a traceability matrix?
Yes, this matrix can be exported at any time from the Traceability tab. The view shown in an active review when sent for approval only includes elements from the current and earlier reviews.
Where would a bug log be kept?
Bugs may be treated as non-conformances and recorded in Events.
If a specification changes, are we alerted to other documents that need to be considered for change (are documents linked within the system)?
The system will not alert for the impacted documents based on the revised document. Thus, when they make a change they need to perform an impact assessment to list out the documents that are impacted. The impact assessment can be a simple table in the change control tab to list the documents/processes.