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We'll cover in detail the differences between GAMP®5, 2nd Edition, issued in July 2022 and the original version of GAMP®5.
The 2nd Edition aligns very well with Computer Software Assurance (CSA), a draft guidance from FDA issued in September 2022.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.
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element is a risk-based, product quality and patient-centric approach to Computer System Assurance (CSA), issued as a draft guidance in September 2022 vs. the traditional Computer System Validation (CSV) waterfall approach.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.
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.
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. You will learn the differences between GAMP®5, 2nd Edition and the original GAMP®5 version, and how the 2nd Edition aligns with many of the principles of Computer Software Assurance (CSA). These can be leveraged to ensure compliance with FDA requirements for validation, 21 CFR Part 11 (electronic records & electronic signatures), and data integrity requirements.
We'll cover the trend toward using non-linear types of software development, testing, and release, such as agile. We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to 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).
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 Session:
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