Technology is rapidly transforming how regulated organizations operate. Systems are becoming more dynamic, interconnected, and data-driven, requiring smarter approaches to validation and compliance. Companies must ensure their software is reliable, compliant, and capable of adapting to continuous change throughout its life cycle.
This webinar explains how traditional Computer System Validation (CSV) practices are evolving toward Computer System Assurance (CSA), with a stronger focus on quality, efficiency, and patient safety. Instead of concentrating only on documentation, modern validation emphasizes critical thinking, risk evaluation, and product knowledge.
We will compare Waterfall and Agile approaches and discuss how organizations can align development activities with the GAMP 5 V Model while still maintaining flexibility. Participants will understand how Agile Validation can support faster releases without compromising compliance.
The session also explores how SDLC Compliance can be maintained in regulated environments through structured yet adaptable development processes. A strong emphasis will be placed on Risk Based Validation to ensure that effort is focused on high-impact system functions rather than unnecessary documentation.
Regulatory expectations, including 21 CFR Part 11 requirements for electronic records and electronic signatures, will also be discussed in the context of modern systems such as cloud platforms and SaaS solutions.
Learning Objectives:-
Areas Covered in the Session:-
Why Should You Attend:-
This session will help you understand FDA’s direction toward modern, quality-focused approaches and how that benefits both regulators and industry. You will learn practical ways to update validation within the SDLC by using automation and continuous testing, making validation more efficient and easier to maintain over time. You will also gain a clear understanding of how Agile and Waterfall compare, how modern validation can still meet regulatory expectations, and what to focus on to keep systems compliant and reliable throughout their entire life cycle.
Who Will Benefit?
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Carolyn Troiano has more than 40 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 participated in the FDA/Industry team that drafted 21 CFR Part 11, the FDA Guidance for Electronic Records and Electronic Signatures (ER/ES). She is active in seeking ways to streamline the validation process and do what she terms “Common Sense Validation,” removing tasks that do not add value, but carefully taking a risk-based approach and using critical thinking to drive plans and activities.
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