Transforming design controls in our new Qualio upgrade
Design controls sit at the heart of how life science devices and software products are planned, developed and brought to market.
But every day that your product spends in development, instead of on the market, costs your company revenue while eroding your competitive advantage.
For our latest Qualio upgrade, we've overhauled, modernized and accelerated our design control functionality to give our customers greater control and speed.
Key highlights include:
Full traceability: an interactive, exportable view of all relationships across all requirements, tests and risks
More flexibility: align design control architecture with your product requirements, not the other way around
Ease of use: searching, filtering and navigation updates to streamline workflows, instant gap analysis, plus auto-generation of documents before approval
Come take a look at what’s coming to Qualio this time!
Revamped design controls keep compliance & product development in lockstep
In recent launch trains, we've updated Design Controls to simplify integration to systems like Jira, GitHub, Azure DevOps, GitLab, and more.
Now, we've revisited Design Controls again and transformed it by harnessing and applying customer feedback, empowering our customers to streamline and speed up their product management with a raft of fresh additions and improvements.
What's changed?
At-a-glance visibility of your design activity - so you know where to act
A new Traceability tab centralizes and visualizes the relationships across your requirements, tests and risks in a single screen.
And a new visual gap analysis immediately pinpoints where your attention is needed. Whether it's an outdated test result, an unresolved risk or a missing connection, pop-up icons in your requirement, test and risk tabs keep you informed and aware - so your compliance doesn’t slip!
Plus, a new and improved review experience offers better visibility of your design status, while one-click design review file generation reduces manual processes and risk.
“The added features are phenomenal!
The traceability view and gap analysis help us ensure everything is accounted for from a design control perspective.
This is the most robust, integrated system I've ever seen in an eQMS.”
– Eric Klumper, Chief Quality Officer, Black Fur Medical
New attributes to structure and simplify your design control activity
Since many products consist of multiple modules, subsystems or components, we've made organizing design elements more flexible – empowering product teams to easily align design control architecture with their own product specifications.
This is particularly impactful for software as a medical device (SaMD) products with complex configuration requirements.
TOP TIP
Elements can also be imported from a third-party tool, like Jira or Azure DevOps.
They'll also appear in any documents you export from Design Controls, giving an extra layer of structure for your colleagues, leadership, or even your auditors to check up on!
We hope you enjoy the latest upgrades and enhancements from our product team.
Stay tuned on the Qualio blog and on our social media channels for more product news in the near future!
