The Design Controls feature in Qualio was built to serve the needs of the Medical Device industry in their efforts to bring new products to market around the world. This feature's foundational element of traceability from user needs, to functions, to testing, also meets the needs of a software lifecycle traceability element as part of validation efforts. Qualio is using the design control feature to provide this traceability to support the platform's software validation efforts on behalf of its customer base. As Qualio does extensive testing of its software utilizing automated testing tools, it makes sense and aligns with the FDA's and other regulatory agencies' "Least Burdensome Approach" to leverage this testing to support the customer's validation efforts. The customer can go on to perform any additional unscripted testing they desire, but the foundational elements of the software tool are tested and complete.

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