GAMP®5, Second Edition and Alignment with FDA’s Draft Guidance for Computer Software Assurance (CSA)

The approach to developing software, performing validation and maintaining a system in a validated state through its entire life cycle should be carefully considered in order to meet changing needs. This webinar will include a comparison of the agile and waterfall methodologies, along with the pros and cons of each. There may not be one size that fits all, and so it is important to understand what needs to be considered when making such a determination.

In each case, waterfall and agile, we’ll map these methodologies to the GAMP®5 “V” Model and provide the pathway and steps for achieving successful validation of systems. GAMP®5, Second Edition, issued in July 2022 aligns very well with Computer Software Assurance (CSA), a draft guidance from FDA issued in September 2022. We’ll cover the pros and cons of CSV and CSA, and the importance of including GAMP®5 best practices in the validation process.

We’ll also cover COTS, SaaS, IaaS, PaaS, and cloud services, indicating the benefits and risks of each model. In discussing these hardware and software options, we’ll include the best practices for meeting FDA’s requirements for validation, 21 CFR Part 11, as applicable, and data integrity. Part of the session will identify the FDA’s current concerns and how to ensure your systems will meet their expectations.

Description:

The FDA has been moving in the direction of newer technology in an effort to no longer be a bottleneck to industry innovation. As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by industry on compliance rather than quality may be diverting resources and management attention toward meeting regulatory compliance requirements vs. investing in automation and digital technologies, which could greatly improve quality and process control.

A key element is a risk-based, product quality and patient-centric approach to Computer System Assurance (CSA), issued as a draft guidance in September 2022 vs. the traditional Computer System Validation (CSV) waterfall approach. CSA encourages critical thinking based on product and process knowledge and quality risk management over prescriptive documentation driven approaches. It also provides the ability to use automated testing to improve validation efficiency and effectiveness.

This is where FDA determined that “WHAT” is required can be done in different ways (the “HOW”) and does not have to be according to the “checklist” mindset of most CSV work, where you crank out documents without specifically addressing the risk of potential failure of each requirement.

GAMP®5 supports the use of incremental, iterative, and evolutionary approaches including agile and automated testing for development of custom applications. 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.

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 approach is amenable to the agile software development methodology, which can be adapted for use in validation. We’ll discuss the pros and cons of each approach, and industry best practices for success.

We’ll cover Computer-Off-the-Shelf (COTS) software, Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), Platform-as-a-Service (PaaS), and cloud services. You’ll learn how to select an optimal solution and ensure that whatever that might be, you can build a contract and Service Level Agreement (SLA) that best suits your environment and needs.

Areas Covered in the Webinar:

• Learn how to identify “GxP” Systems
• Learn about FDA’s current thinking about technology and software development, and how this will impact industry
• Discuss the current state of 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
• 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 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 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

Who Will Benefit:

This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance.

Examples of who will benefit from this webinar include:

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• Risk Management Professionals
• Clinical Data Analysts
• Clinical Data Managers
• Clinical Trial Sponsors
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers

This webinar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

Carolyn Troiano
ERP Project Manager, City of Richmond

Carolyn Troiano has more than 30 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.

Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

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