As part of the Case for Quality program US FDA CDRH (Center for Devices and Radiological Health) has 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 businesses 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 the 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 those 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 the 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 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 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.

Learning Objectives:-

• Learn how to identify “GxP” Systems
• Learn about FDA’s current thinking about technology and software development, and how this will impact the industry
• Discuss the current state of Computer System Validation (CSV) approach based on FDA requirements
• Learn about the System Development Life Cycle (SDLC) approach to validation and how this can be modernized through a more agile approach, including automated testing for continuous validation
• Understand the differences between CSA and CSV, and how critical thinking vs. documentation as the primary driver can shift a company’s focus and improve the delivery of useful functionality at a much more rapid pace while maintaining compliance
• Learn the pros and cons of an Agile vs. Waterfall approach
•  We will discuss cloud computing and Software as a Service (SaaS) systems that can be embraced and validated effectively
• Discuss the best practices for documenting computer system validation efforts, whether using a Waterfall or Agile approach, including requirements, design, development, testing, and operational maintenance procedures, including ways to improve efficiency and effectiveness of managing related documentation
• Understand how to maintain a system in a validated state through the system’s entire life cycle in a more cost-effective manner, applying an Agile continuous validation approach
• Learn how to assure the integrity of data that supports GxP work, despite changes and advances in new technology
•  Discuss the importance of “GxP” documentation that complies with FDA requirements
•  Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
•   Know the regulatory influences that lead to FDA’s current thinking at any given time
•  Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
• Q&A

Why Should you Attend?

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.

Who Should Attend?

• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Managers
• Manufacturing Supervisors
• Supply Chain Specialists
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance, and audit
• Consultants working in the life sciences industry who are involved in computer system implementation, validation, and compliance
• Auditors engaged in the internal inspection of labeling records and practices