UAT Roadmap: Quality by Design

Part 1 – What Is Quality by Design & How to Implement It

Ensuring data quality and reliable outcomes is essential in research. User acceptance testing (UAT) and your quality assurance unit’s (QAU) role should not be an afterthought. Though UAT starts when an initial study build is completed (or close to it), at which point a QAU is invited to participate, it is worth considering asking a QAU to get involved much before. Enter Quality by Design (QbD)… 

Quality by Design (QbD) is a strategic approach emphasizing the need to build quality into a study’s design rather than relying solely on testing. In this article, we will dive into the principles of QbD, how to implement it, and its impact on studies. 

The basic principle of Quality by Design (QbD) is that quality cannot be tested into products, but that quality should be built in by design.

At its core, the principle of Quality by Design (QbD) revolves around the idea that quality cannot be “tested into a product,” the product being a study or experiment in the research world. Instead, quality should be built into the design from the very beginning. Breaking down that principle… 

“Why can’t quality be tested into a product?”  

You cannot expect quality in the output if there is no quality at the input.  

“How do you build quality in by design?”  

When the “product” is a study, building quality into design goes back to the protocol where the study setup is outlined in detail. A protocol written with quality in mind will lay out key elements of a study – the randomization process will be spelled out, how adverse events are coded will be specified, and masking will be clearly defined. When you outline the details of these elements at a granular level, it makes building a study more straightforward – data managers have complete specifications to build out the study. And, the testing phase becomes simpler – guesswork is removed, and everyone knows what results to expect when testing. 

Implementing Quality by Design When Building Studies in an EDC 

Implementing Quality by Design (QbD) in a study involves the active engagement of quality personnel, often referred to as the Quality Unit (QU) or Quality Assurance Unit (QAU), from the early stages. To implement QbD: 

Involve quality personnel early on. 

Though quality personnel are only sometimes involved in writing a protocol, it is recommended that they review the protocol before finalization to ensure that details and documentation relating to an Electronic Data Capture (EDC) system used to collect data are included. 

During the study build phase, by allowing quality personnel to review the forms at this stage, quality can look for and capture necessary steps that should be written into a validation plan or testing script. If access at this point is not an option, involving quality in the first round of feedback, before User Acceptance Testing (UAT), is the next preferable option, so quality can ensure that UAT is thorough and conducted correctly. Ultimately, the sooner a QAU is involved, the fewer questions they will have about the build and the data collected. 

Grant quality personnel access to the system. 

Ideally, quality personnel should be able to access the Electronic Data Capture (EDC) system to review the study setup before writing a testing script begins. A role specifically for quality personnel can be created with read-only access. 

Quality personnel’s early involvement reduces the likelihood of data-related issues emerging later and allows the QAU to ensure that the study is adhering to Good Clinical Practices (GCP), Good Lab Practices (GLP), Part 11/Annex 11 compliance, etc. 

Impact of Quality by Design on Studies 

Pros of QbD

• Assurance that the study build reflects the protocol. 
• Improved study builds as data managers can implement quality’s feedback early on, leading to fewer fixes, errors, and rounds of feedback. 
• Understanding of the study build and its intricacies by quality personnel, including edit checks, calculations, and automation. 
• Ability to catch any compliance issues early to reduce the risk of regulatory issues later. 

• Better testing scripts so that User Acceptance Testing (UAT) is more straightforward and efficient, and less time-consuming. 
• And finally, another perspective when collecting feedback before UAT. 

Cons of QbD

• Implementing QbD may take longer initially due to planning and coordination.  

Tips to Avoid Delays: 

• Ensure that everyone involved understands the importance of quality and how to incorporate it into the study. 
• Include a quality colleague in meetings with your Electronic Data Capture (EDC) customer success manager so they may learn about the system’s capabilities. 
• Be flexible – there are multiple ways to build out EDC forms per your protocol, each with pros and cons. 

Quality by Design (QbD) is not a buzzword or fad, but a vital approach to ensure the integrity of studies. By embedding quality from the beginning, building studies is easier and faster, data quality is improved, and meeting the requirements of regulatory compliance is smoother. While it may require a little more effort upfront, the benefits of QbD far outweigh the cons, making it a worthwhile approach in the realm of research.