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ROI CalculatorA User Requirements Specification (URS) describes what a quality management system (QMS) needs to do (i.e., its functionality, security, and compliance capabilities). User Acceptance Testing (UAT), on the other hand, verifies the QMS performs the intended functions after being implemented.
These two items are the basis for software validation in regulated environments.
URS and UAT help quality teams identify QMS software that meets the requirements of your company by matching the capabilities of the software.
If you choose to implement an electronic quality management system (eQMS), defining your requirements and testing against those requirements are essential steps in establishing that the selected software, once implemented, is validated and fits the intended use in the eyes of regulatory bodies.
UAT is the primary part of the eQMS validation process, thus UAT entails individually testing each of your requirements against eQMS capability to ensure it adequately meets your needs. This is critical as there is no way to validate the requirements, other than through a method of testing the requirements.
To verify an eQMS, you must create a list of user acceptance testing scripts required to complete each requirement and execute those scripts within the testing environment of the system.
After completing all UAT scripts, you can determine whether the selected QMS is appropriate for use. If requirements meet during the performance of the UAT, you will be fine. However, if any requirements are not satisfied, you will want to assess the impact that these failures will have on your business operations.
If the risk associated with the unmet requirements is low, you may be able to continue using the system, since not all requirements are going to be of equal priority. However, if the risk is high, for example, if the system does not meet the requirements outlined in 21 CFR part 11, you will want to consider moving to a different QMS, which would require you to start the entire selection process again.
Here’s a step-by-step process of performing a UAT:
1. Formulate UAT Test Scenarios & Cases
2. Identify Suitable Participants
3. Set up a Dedicated UAT Environment
4. Provide Instructions & Access
5. Automate Workflows + Evidence Capture
6. Execute Test Cases
7. Review & Fix Issues
8. Approve & Go Live
