Gain an understanding of how newer technology should be handled when performing validation work. A different approach will be covered during the session.

We will also discuss best industry practices to ensure all systems, including technology that has been around for decades, yet until recently, these were rarely used in the life science industry. (e.g., cloud, Software-as-a-Service (SaaS), Electronic Records/Signatures)

Areas Covered

This webinar will cover the following key areas:

Course Level - Intermediate

Who Should Attend

Personnel in the following roles will benefit:

Why Should You Attend

The attendees will learn about the FDA’s approach to modernizing technology, and how that will benefit both the Agency and the 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.

Topic Background

Advancements in technology have forced organizations to rethink 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 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, 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.

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, the US FDA Center for Devices and Radiological Health noted how an excessive focus by the 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 the 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 the 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.