DUBLIN, November 21, 2023 /PRNewswire/ — The “3 Hour Virtual Seminar on IT System Validation (CSV) vs. IT Software Assurance (CSA) – Following a Waterfall or Agile Methodology” the webinar has been added to ResearchAndMarkets.com offer.
As part of the Case for Quality program, the U.S. FDA’s Center for Devices and Radiological Health noted how excessive industry focus on compliance rather than quality could divert resources and management focus towards meeting regulatory compliance requirements rather than adopting quality best practices.
Investments in automation and digital technologies have also been lower than expected, which could greatly improve quality and process control. A key element is a risk-based, product quality and patient-centric approach to IT System Assurance (CSA), versus the traditional waterfall approach to IT System Validation (CSV). This encourages critical thinking based on product and process knowledge and quality risk management rather than prescriptive, documentation-based approaches.
This is where the FDA has determined that “WHAT” is required can be done (the “HOW”) in different ways and does not necessarily have to conform to the “checklist” mindset of the Most CSV jobs, where you write documents without specifically addressing the potential failure risk of each requirement.
GAMP5 supports the use of incremental, iterative, and scalable approaches, including Agile, for custom application development. Keys to success include a robust quality management system and well-trained, highly disciplined teams following well-defined processes supported by tools and automation.
Technological advances have forced organizations to rethink their business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers who are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
The approach to developing software, performing validation, and maintaining a system in a validated state throughout its life cycle must be carefully considered to meet changing needs. This webinar will include a comparison of Agile and Waterfall methodologies, as well as the advantages and disadvantages of each. There may not be a one-size-fits-all solution, and so it is important to understand what needs to be considered when making such a decision.
Why you should attend:
The attendee will learn about FDA’s approach to technology modernization and the benefits it will bring to both the Agency and industry. We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to computer system validation (CSV) using automated testing tools that will drive continuous validation of software products. This approach lends itself to the Agile software development methodology, which can be adapted for use in validation.
We will also discuss the important aspects of CSV and how to apply them in a new and modern technological environment.
Key topics covered:
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Learn to identify “GxP” systems
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Learn about FDA’s current thinking on technology and software development and their impact on the industry.
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Discuss the current status of the Computer System Validation (CSV) approach based on FDA requirements
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Learn about the System Development Lifecycle (SDLC) validation approach and how it can be modernized with a more agile approach, including automated testing for continuous validation.
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Discover the advantages and disadvantages of an Agile or Waterfall approach
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We will discuss cloud computing and software as a service (SaaS) systems that can be adopted and validated effectively.
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Discuss best practices for documenting IT systems validation efforts, whether using a Waterfall or Agile approach, including requirements, design, development, testing and operational maintenance procedures, including means of improve the efficiency and effectiveness of the management of associated documentation.
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Understand how to maintain a system in a validated state throughout its lifecycle in a more cost-effective manner, applying an Agile continuous validation approach
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Learn how to ensure the integrity of the data that supports GxP work, despite changes and advances in new technologies.
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Discuss the importance of “GxP” documentation that meets FDA requirements.
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Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state.
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Know the regulatory influences that drive current FDA thinking at any given time
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Finally, understand industry best practices that will enable you to optimize your validation and compliance approach, based on risk assessment, to ensure data integrity is maintained throughout its lifecycle.
Speaker
Carolyn Troiano has over 30 years of experience validating IT systems in the pharmaceutical, medical device, animal health, tobacco and other FDA regulated industries. She is currently an independent consultant, advising businesses on IT system validation and large-scale IT system implementation projects.
During her career, Carolyn has worked directly or in a consulting capacity for many major pharmaceutical companies in the United States and Europe. She developed validation programs and strategies in the mid-1980s, when the first FDA guidance was issued on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11 , FDA regulations on electronic records and electronic signatures.
Carolyn has attended industry conferences. She is currently active in PMI, AITP, and RichTech, and volunteers for the PMI Educational Fund as a project management instructor for nonprofit organizations.
For more information about this webinar, visit https://www.researchandmarkets.com/r/kf6r56
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