As part of the Case for Quality program US FDA CDRH (Center for Devices and Radiological Health) have identified that an excessive focus on compliance rather than quality may divert resources and management attention towards meeting regulatory compliance requirements rather than adopting best quality practices. This is also related to low investment in automation and digital technologies, which could greatly assist in quality improvements and process control. An important element of the program is to promote a risk-based, product quality and patient centric approach to computerized systems assurance. This encourages critical thinking based on product and process knowledge and quality risk management over prescriptive documentation driven approaches.

GAMP®5 strongly supports the adoption of new and innovative computerized technologies and approaches throughout the product life cycle to support data integrity, product quality, patient safety, and public health.

GAMP®5 supports the use of incremental, iterative, and evolutionary approaches including Agile and CSA for product development and development of custom applications. Note that success factors for this include a robust Quality Management System within an appropriate organizational culture, well-trained and highly disciplined teams following a well-defined process supported by effective tools and automation, and proper customer or product owner involvement.

Many of the newer advancements in technology have resulted in organizations having to revisit and rethink their business models and strategies. Consumer expectations are much higher now for increased functionality and ease of use of products, and business must respond accordingly.

Waterfall programs and projects have often been focused on the company’s needs, rather than the end customers. Often, they were opinion driven by management that a given strategy was right rather than the result of research and data. This has resulted in software release cycles that generally have been measured in quarters or years, often resulting in large releases that require extensive and time-consuming training on the new systems. They also delay delivery of useful functionality into the hands of clients until it can be bundled economically in some future release. We’ve all had the experience where a company chooses to put off new releases of code because there’s too much overhead associated with testing and validation. Without automated testing and a more efficient approach, such as offered with agile, companies will never shift gears and start improving delivery.

We can adopt an agile approach that can transform the way organizations work and behave, and can better meet consumer expectations. Work practices and tools must change to achieve this and sustain it.

Agile must be supported by a culture of innovation and continuous improvement. Teams must be empowered with the ability to deliver across locations and functions. Stakeholders must be aligned to the new way of doing business.

It also forces individuals to let go of past ideas and practices, and focus on what FDA requires rather than doing things the old way because it worked and it’s easier.

The blending of waterfall and agile can also be adopted, and it should occur at the beginning of the project, when, for example, in the agile Scrum methodology, a product backlog must be prepared, reflecting requirements. Even though this product backlog may not be fixed in stone, most successful projects used the frequent delivery approach of agile (two weeks, four-week sprints) but with a robust preliminary definition of what would be the final product, or “customer experience.”

One of the things FDA has stressed in recent years is that you have to stop assuming every document requires a human being to complete manually.  They are supportive of industry’s movement to an agile approach with automated testing.  “What” you are required to do is the same, but “how” you do it is up to each company to determine.

The focus should be on asking the question “why” you are doing the testing and thinking about it critically. The documentation will follow, but shouldn’t lead the charge.

The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry.  We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV) by using automated testing tools that will result in a continuous validation of software products. This brings into use the Agile methodology for software development. It also lends itself to Computer Software Assurance (CSA), an  approach that unlike the document-centric CSV methodology, focuses on critical thinking as the driver for delivering quality software that can be continuously validated.

We will also discuss the important aspects of CSA and how to apply them in a new and modern technological environment. You will learn about the pros and cons of CSV vs. CSA, and waterfall vs. agile as a methodology for developing and delivering new software and systems.