Do Low-Risk Items Require Validation?

USDM Life Sciences is not suggesting not to validate any of your low-risk requirements. The important aspect to remember is if your implementation processes are documented, sound, repeatable, and your vendor has evidence of all the testing that they've done, you may not need to test out of the box functionality items that are considered to be low risk.

If you have items that are not GxP or low-risk GxP, depending on its complexity and configuration, you may have some informal user acceptance testing. You can leverage your supplier’s testing to have confidence in certain areas of the system’s functionality. You know the system can add 2 + 2; therefore, writing new test scripts may not be necessary. You can call back on the supplier testing if need be.

The majority of minor low-risk user testing items are going to be part of end-to-end, formal PQ testing, or integration testing. You are going to capture the information during this part of the testing and can reference those items when needed. Essentially, it would be redundant to write a specific test focusing upon that particular requirement on its own.

The USDM Life Sciences Cloud Practice is the one you can trust when looking to move applications and business processes to the Cloud. Our team of cloud experts understand compliance, validation, implementation, mobile, data security, data migration, and system integration, and we ensure that leading cloud vendors meet and maintain compliance regulations around the globe.