GAMP®5, 2nd Edition and Alignment with FDA’s Draft Guidance for Computer Software Assurance (CSA)

Technology breakthroughs have driven companies to rethink their business strategies. Once organized and regulated, these companies are now more complex, serving patients and consumers with higher expectations. To address these challenges, work habits and equipment must be updated.

Adapting to these changes requires careful attention to software development, validation, and maintaining systems throughout their life cycle. This webinar will compare the waterfall and agile approaches, exploring their pros and cons. Since no single solution fits all, understanding key factors is crucial for making informed decisions.

We'll map both waterfall and agile approaches to the GAMP®5 "V" Model, outlining stages for successful system validation in each. GAMP®5 (Second Edition, July 2022) aligns well with FDA Draft Guidance on Computer Software Assurance (CSA, September 2022). We'll compare CSV and CSA, emphasizing GAMP®5 best practices in validation.

The webinar will cover cloud models (IaaS, PaaS, SaaS, COTS), along with their pros and cons, best practices for meeting FDA's 21 CFR Part 11 criteria and maintaining data integrity. We'll also discuss the FDA's recent focus on modern technology, noting its shift from compliance to quality to support innovation.

The CSA guidance, issued in September 2022, promotes a risk-based, quality-centric approach over the traditional checklist-heavy CSV method. CSA encourages critical thinking, product knowledge, and quality risk management, allowing automated testing for efficient validation. FDA highlights that “WHAT” requirements can be achieved through various “HOW” methods, reducing reliance on exhaustive documentation.

For the creation of custom applications, GAMP®5 facilitates the use of incremental, iterative, and evolutionary methodologies, including automated and agile testing. Keys to success include a robust Quality Management System (QMS) and well-trained and highly disciplined teams following well-defined processes supported by tools and automation.

The participant will gain knowledge about the FDA's strategy for updating technology and how it will help the business community as well as the Agency. We will talk about how to use automated testing tools to create a continuous validation of software products, modernizing the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV). The agile software development technique can be applied to this approach and modified for validation purposes. We'll go over the benefits and drawbacks of each strategy as well as successful industry best practices.

Cloud services, Infrastructure-as-a-Service (IaaS), Platform-as-a-Service (PaaS), Software-as-a-Service (SaaS), and Computer-off-the-Shelf (COTS) software will all be covered. You will get knowledge on how to choose the best possible solution and make sure that, whatever it may be, you can create a contract and Service Level Agreement (SLA) that are tailored to your needs and environment.

• Gain an understanding of how mobile applications should be handled when performing validation work
• Understand the best practices for maintaining a mobile application in a validated state
• Discuss the best practices necessary to ensure all systems, including mobile applications, are validated appropriately
• Learn how to develop the appropriate computer validation strategy when dealing with mobile applications to ensure a good balance of cost vs. risk
• Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization, as they begin to include mobile applications
• Learn how to gain information about trends in the validation of mobile applications, as the industry progresses and new best practices emerge
• Understand some of the key “pitfalls” to avoid when applying the concepts of computer system validation to mobile applications

• Learn how to identify “GxP” Systems
• Learn about the FDA’s current thinking about technology and software development, and how this will impact the industry
• Discuss the current state of the Computer System Validation (CSV) approach based on FDA requirements and the Computer Software Assurance (CSA) approach, based on the draft guidance from FDA in September 2022
• Learn about GAMP®5, Second Edition, and how it aligns more closely with the CSA approach to validation
• 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
• Learn about cloud services and cloud service providers to optimize your experience
• Learn ways to validate in the cloud without compromising quality or compliance
• Learn the pros and cons of an agile vs. waterfall approach
• We will discuss cloud computing, Computer Off-the-Shelf (COTS) software validation, and Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), and Platform-as-a-Service (PaaS) systems that can be embraced and validated effectively
• Talk about the best ways to manage related documentation more effectively and efficiently when documenting computer system validation efforts, whether they are done using an agile or waterfall methodology. This includes requirements, design, development, testing, and operational maintenance procedures.
• Understand the best approach to Installation Qualification (IQ) testing when the system components are not on-premise but in the cloud
• 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 ensure 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

Rapid technological advances are driving companies to rethink strategies to manage complexity and meet rising consumer expectations. This shift demands updated work practices and tools to maintain reliable, validated systems. With the FDA’s Case for Quality initiative prioritizing quality over mere compliance, companies are encouraged to adopt automation and digital solutions for improved quality and process control. A strong Quality Management System (QMS) and clear, automated processes are essential for navigating these regulatory and technological changes successfully.