By Kathleen Greenough, Director of Client Solutions, and Laura Araujo, Vice President of Quality, 4G Clinical
I was sitting in a recent IRT conference when the topic of User Acceptance Testing (UAT) was addressed. The speaker said they use UAT as a process to find bugs in the software, to ‘validate’ the system. I looked around the room and saw heads nodding. Huh? How did we get here? When did UAT become a surprise party where the trial sponsors used this as an exercise to find bugs and quality issues in the software?
Remember, the vendor is responsible for ensuring the system is properly validated to perform to requirements. The sponsor needs to accept the system for use and this process, UAT, involves having the sponsor interact with the system and signing-off that it works as intended – or is fit-for-purpose.
Does fit-for-purpose mean the software works? Or does it really mean that it performs to your study specifications laid out in your protocol? If we can all agree on the latter, let’s stop viewing UAT as a bug finding expedition and start raising the bar on the system that is presented to you at UAT.Do you as a sponsor need to demonstrate oversight of your RTSM vendor and their processes? Absolutely. Do you need to ensure that critical systems like RTSM are correctly supporting your studies? Of course. Do you need to revalidate the RTSM after you vendor does to prove this? No.
Easier said than done? Sure, but here are best practices for getting the most of out of your UAT process – and focus your efforts where they should be.