Qualio Design Controls is used by companies creating medical device software to structure, strengthen and centralize their software development and quality activities.
This article is written for software as a medical device (SaMD) customers who will use a third party integration (JIRA, Azure DevOps, etc.) as the source for documenting design elements.
Want to learn more about Design Controls first? Get an overview here or take a tour here, or jump to a section in this article:
Permissions and Access
Design Controls is available to all customers on Starter, Growth, and Plus plans for no additional fee. If you are not on one of these plans, or have questions about your current plan, please consult with your Customer Success Manager.
Design Controls must be enabled by customer request via the in-app chat. We recommend enabling the feature first in your sandbox, validating the feature, then enabling and launching in your production environment.
Design Controls can be enabled for all users or a select group of users in any role. Access to the Design Controls tab will give access to the entire suite of Design Control features, including configuration settings. The only discrete permission is the ability to approve changes, which is reserved only for Quality users. Therefore, it is recommended to enable the feature judiciously. Once again, we recommend enabling Design Controls in your sandbox first.
Note: if a user with access to Design Controls changes from one user role to another (ex: Normal to Quality) the Design Controls tab will need to be re-enabled.
Design Controls Validation
Qualio does extensive testing of its software utilizing automated testing tools and we use Design Controls internally for traceability from user needs, to functions, to testing. Then we make those resources available to customers to support their software validation efforts. This validation strategy aligns with the FDA's and other regulatory agencies' "Least Burdensome Approach". Learn more about this new validation approach here.
Click the button below to access and download the Design Controls Feature Validation Pack. Customers can perform additional unscripted testing as needed to fulfill their organization’s validation protocols.
Configure Products, Requirements and Risk
When a third-party system will be used as the source for documenting design requirements and testing, an integration with Qualio will need to be created. This will require a Qualio engineer and is tracked via a support ticket.
To get started, complete the Design Controls Survey below for EACH UNIQUE product you wish to use in Design Controls. You’ll need to provide:
Product Name
Up to three levels of requirements (labels, prefix, and statuses)
Requirement source(s) (i.e. JIRA, Azure DevOps)
Risk Management Policy details
Risk levels (can choose 3-5 levels) labels and if risk mitigation is required for each level
3X3 or 5X5 Impact / Probability
Impact and Probability labels (ex: Low, Medium, High or 1, 2, 3, etc.)
Which risk levels are unacceptable and require mitigation
If you wish to record and track FMEA, scale and mitigation levels
Risk record statuses
The Risk policy may be configured by the end user after the product has been created and integrated with the third party system.
Configure Third Party System Integration
Once the survey has been submitted, a Qualio team member will respond to the email address provided on the survey for any additional details and to coordinate next steps. This next step will require the assistance of a third party system administrator.
For detailed instructions, click on the appropriate third party system button: