2) Understand What Level of UAT is Necessary
The process for UAT testing varies widely across the industry. Some organizations don’t conduct UAT at all while others have teams of people writing scripts and essentially revalidating the system after the vendor does. There needs to be a balance. With a 100% configurable and fully cloud based RTSM, UAT can be directed at the critical functions of the system as well as any new functionality. Major findings should be a red flag to overall quality issues. The process of UAT should be used to bring to the forefront additional needs that the sponsor may not have thought of prior to seeing the system, not serve as a software testing exercise .
"'How much validation is enough?' is a question that all sponsors struggle with. By focusing on those areas that introduce the highest risk to the study; particularly those that are not sufficiently covered by the vendor - should help sponsors hone in to exactly what they need to do to complete the validation of their RTSM."-Laura Araujo, Vice President, Quality, 4G Clinical
3) RTSM SME Should Drive the User Acceptance Testing Process
To ensure your user acceptance testing is executed as efficiently as possible, this process should be managed by your RTSM project lead or SME. As part of this role, the RTSM SME should pre-schedule testing with all participants. This way, the participants have a dedicated period of time to spend in the system testing and won’t bypass or rush through this important step in system go-live. A well thought-out and executed UAT lends itself to a higher quality product. Don’t have an RTSM SME in your organization? That is absolutely okay. In that case, identify a single person on your study team that is responsible to ensure UAT takes place and look to your RTSM vendor to guide your teams regarding UAT best practices and process.
4) Actual RTSM Users Should Participate in UAT
As technology has advanced, sponsors now have the ability to see a fully deployable system before UAT. With the use of agile software methodologies, customer feedback can be incorporated into the RTSM development process. Instead of receiving the system right before UAT, the sponsor can see the system before signing the specifications, and in some cases, in a demo before seeing the actual spec for the first time. The benefit to the customer is the ability to interact with the system and provide feedback during several iterative process loops. They know what system they are getting well before they sign-off on the specifications. The increased transparency and customer involvement from receipt of the draft protocol ensures UAT will be a final check and there will not be delays to their study.
"The RTSM vendor begins the validation process with the goal of reducing the sponsors overall risk of using the system. Proper validation and testing by the vendor should ensure the sponsor validation is simply a final check that everything is in place. UAT shouldn't be a surprise party if the vendor does their job upfront with testing and validation."
-Laura Araujo, Vice President, Quality, 4G Clinical
Bottom Line: The Conversation around UAT Needs to Change.
The above best practices are important but to be truly effective the conversation around UAT in the industry needs to change. If sponsors continue to accept UAT as a method to find bugs and quality issues, the process for delivering systems will not evolve. If we truly want to change this thinking, RTSM vendors must also do their part and provide systems for UAT that do not have quality issues. If there is one thing I can leave you with is to change your expectations around UAT and RTSM system delivery. The technology is there and quality should not be in question as you approve your system as fit-for-purpose.
Looking for more best practices? Watch our webinar on Best Practices for User-Acceptance Testing (UAT) in Clinical IRT/ RTSM Systems
