Implementing CSA for GxP Systems - Transition, Documentation, and Post-Transition Challenges and Opportunities (ONLINE EVENT: October 16-17, 2025)

This 2-day online course provides an in-depth guide to implementing Computer Software Assurance (CSA) for GxP-regulated systems. 

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.

Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997, and disseminated through 21 CFR Part 11. This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.

In the early 2000s, FDA recognized they could not inspect every computer system at every regulated company and placed the onus on industry to begin assessing all regulated computer systems based on risk. The level of potential risk, should the system fail to operate properly, needed to be the basis for each company’s approach to developing a validation approach and rationale as part of the planning process. System size, complexity, business criticality, GAMP®5 category and risk rating are the five key components for determining the scope and robustness of testing required to ensure data integrity and product safety.

Until recently, the traditional approach to Computer System Validation (CSV) was believed to be required by FDA. It was also believed that following GAMP®5 practices was also a requirement. While FDA will tell industry WHAT is required, they have never dictated HOW those requirements should be met. Each company that is FDA-regulated must use critical thinking, as described in the CSA approach to come up with the most practical and innovative way to adhere to the regulations. They still must meet WHAT FDA requires, but HOW must be evaluated and determined in order to comply.

GAMP®5, Second Edition aligns well with CSA, and the two used in concert can provide a more effective and efficient means of reaching compliance for computer systems used in regulated processes.

Why Should You Attend

This Seminar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.).

Attendees will learn how to adapt their current method of validating FDA-regulated computer systems to align with both GAMP®5, Second Edition, published in July 2022, and CSA, a new approach that is subject of a Draft guidance from FDA that was issued in September 2022. These two guidances will reshape the way companies handle validation of computer systems that are based on newer and more innovative technologies.

Rather than avoiding these modern breakthroughs in technology and continuing to rely on older ways of conducting business, attendees will learn how to adapt their current practices and thinking about validation to leverage these innovative tools and advance their ability to bring their companies to a new level of success. Newer technologies will help them bring more advanced products to the marketplace and this can be achieved by learning how to approach validation to continue meeting FDA compliance. These include cloud-based services, Software-as-a-Service (SaaS) solutions, and software that incorporates Artificial Intelligence (AI), Machine Learning (ML) and Large Language Models (LLMs), such as ChatGPT.