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 is driven approaches.
GAMP® 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® supports the use of incremental, iterative, and evolutionary approaches including Agile, 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.
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 the FDA has stressed this past year is that you have to stop assuming every document requires a human being to complete it manually. They are supportive of the 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 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.
We will also discuss the important aspects of CSV and how to apply them in a new and modern technological environment. You will learn about the pros and cons of waterfall vs. agile as a methodology for developing and delivering new software and systems.
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.
During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.
Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI's Educational Fund as a project management instructor for non-profit organizations.