GAMP®5, 2nd Edition and Alignment with FDA’s Draft Guidance for Computer Software Assurance (CSA)

Technology breakthroughs have compelled companies to reconsider their business strategies. These companies, which used to be more organized and regulated, are now more chaotic and complex, servicing patients and consumers who have higher expectations and are better informed than before. To overcome these problems, work habits and equipment need to be modified

To adapt to changing needs, attention should be taken in the process of building software, carrying out validation, and keeping a system in a validated state across its whole life cycle. The waterfall and agile approaches will be compared in this webinar, along with the benefits and drawbacks of each. There could not be a single solution that works for everyone, so it's critical to know what factors to take into account before making such a decision.

We'll map both waterfall and agile approaches to the GAMP®5 "V" Model and offer the stages and route for accomplishing successful system validation in each scenario. GAMP®5, Second Edition, published in July 2022, is highly compatible with FDA Draft Guidance on Computer Software Assurance (CSA), published in September 2022.)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 discuss cloud services, IaaS, PaaS, SaaS, and COTS, outlining the advantages and disadvantages of each model. We'll cover the best practices for fulfilling the FDA's validation criteria, 21 CFR Part 11, if applicable, and data integrity when talking about various hardware and software choices. The FDA's current concerns will be covered in part of the presentation, along with tips on how to make sure your systems live up to their standards

To try to get out of the way of corporate innovation, the FDA has been pushing toward more modern technology. The US FDA Center for Devices and Radiological Health highlighted as part of the Case for Quality program how an overemphasis on compliance by the industry, as opposed to quality, may be rerouting resources and managerial attention toward satisfying 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element is a risk-based, product quality and patient-centric approach to Computer System Assurance (CSA), issued as a draft guidance in September 2022 vs. the traditional Computer System Validation (CSV) waterfall approach.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 prefers prescriptive documentation-driven approaches to critical thinking based on product and process knowledge and quality risk management. Additionally, it offers the option to employ automated testing to raise the efficacy and efficiency of validation.

The FDA came to the conclusion that the "WHAT" requirements might be fulfilled in a variety of methods (the "HOW") and did not necessarily need to follow the "checklist" approach of the majority of CSV work, which entails producing documents quickly without considering the possibility that any one of the requirements could fail

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.

Webinar Objectives

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.

Webinar Agenda

• 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
• 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 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

Webinar Highlights

• 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 validation of mobile applications, as 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

Who Should Attend

• Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:
• Pharmaceutical (for drug products introduced using a medical device)
• Medical Device
• Biologicals (for biological products introduced using a medical device)
• Tobacco (based on the Tobacco Control Act of 2009)
• E-Liquid/Vapor (based on the “Deeming” Act of 2016)
• E-Cigarette (based on the “Deeming” Act of 2016)
• Cigar (based on the “Deeming” Act of 2016)
• Third-Party companies that support those in the above industries, including Contract Research Organizations (CROs)
• Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to FDA
• Personnel in the following roles will benefit:
• Information Technology Analysts, Developers, Testers, Support Personnel
• 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