How to Transition from Classic (CSV) to (CSA) – Improve Both Compliance and Efficiency

How to Transition from Classic Computer System Validation (CSV) to Computer Software Assurance (CSA) – Improve Both Compliance & Efficiency 

Computer System Validation Following CSA to Ensure the System is FDA-Compliant
Using CSA to Streamline Work and Achieve Compliant FDA-Regulated System Validation

We can begin using some of the CSA principles today, even outside of the intended focus for the final guidance. This is provided that for these other areas, we are able to adequately explain their use and defend the tie-in to Part 11, data integrity, the Quality Management System (QMS), and other relevant documents and programs.
In this webinar, we’ll provide an overview of the transition process in going from CSV to CSA. We’ll then dive into a step-by-step guide for the transition that can be done by any company. The transition steps, related documents, and other artifacts, and the potential issues to watch out for will be laid out very carefully.

The webinar will include a Q&A session. There is also an Appendix at the end of the slide deck that provides an example of performing this transition for Labware Laboratory Information Management System (LIMS). This is a typical system used by many companies in industry and provides good insight as to the detailed information needed to transition from CSV to CSA and complete your validation effort following the latter.

Learning Objectives:-

• Understand current regulatory trends in the industry for compliance and enforcement
• Understand how to determine whether a computer system requires validation and is “GxP.”
• Understand the true validation principles, first set forth in 1983 & last updated in 2002
• Learn about a strategic approach to performing validation consistently across systems in the enterprise
• Learn step-by-step how to transition your validation program from CSV to CSA
• Learn about the changes in GAMP^®5, 2^nd Edition vs. the original GAMP^®5, & alignment with CSA
• Understand the best practices for planning a validation effort
• Learn about validation testing and how CSA can provide an easier pathway, particularly for lower-risk requirements that may be subjected to verification vs. traditional scripted testing
• Understand the documentation that remains required by the FDA, particularly change control
• Learn the concepts about 21 CFR Part 11 compliance for electronic records and electronic signatures
• Understand the concepts of data integrity as expressed in the “ALCOA+” principles
• We’ll cover industry best practices to ensure the transition is smooth.

Areas Covered in the Session:-

During this webinar, the following areas will be covered:

• FDA regulatory trends
• Determining whether a computer system requires validation, and if so, to what extent
• Understanding how the CSA final guidance for medical device companies can be leveraged
• Understanding how some of the CSA principles can be leveraged today
• Understanding how CSA and GAMP5, 2^nd Edition align
• Knowing how much testing is enough
• Following a risk-based approach to validation
• Using critical thinking as a driver of the approach to validation
• Understanding COTS, SaaS, and cloud technology and how to validate these environments
• Knowing what to ask a vendor when evaluating their products and services for use in GxP areas
• Knowing how to plan, execute, and document validation work
• Understanding the aspects of 21 CFR Part 11 that must be adhered to
• Understanding the ALCOA+ principles of data integrity and how to comply
• Reviewing industry best practices to determine the best approach forward using CSA
• Q&A.

Background:-

The life science industries, including pharmaceutical, medical device, biotechnology, biological, and tobacco and tobacco-related products, continue to embrace new technology to improve the delivery of quality products in compliance with the Food & Drug Administration (FDA). In addition, we’ve seen a trend toward making use of cloud services, Software-as-a-Service (SaaS) solutions, and other technical innovations such as the use of Artificial Intelligence (AI), Machine Learning (ML), and Large Language Models (LLMs), such as ChatGPT, that have more recently begun to be used more heavily in life science companies.

As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where newer technologies are becoming prevalent.

It is time to embark on replacing classic Computer System Validation (CSV) with Computer Software Assurance (CSA), the draft guidance from the FDA in 2022, to validate our FDA-regulated systems. More recently, in September 2025, CSA was issued as final guidance, but for a specific area of focus: medical device manufacturing and quality testing operations. This transition has the promise of both greater compliance and efficiency, while companies continue to deliver quality products to meet the needs of consumers by putting newer, more innovative, safer, and more effective products in their hands, all of which are key focus areas for the FDA.

Why Should You Attend?

Providing safe and effective medical devices, drugs, and other FDA-regulated products is in the best interests of all those involved in the development, manufacturing, testing, and distribution of these products. You will learn about the FDA’s CSA approach to take advantage of newer technologies and innovations, including cloud services and Software-as-a-Service (SaaS) solutions. CSA will provide a more practical approach to testing and verification of requirements based on potential risk, should they fail to operate properly. It’s no longer a “one-size-fits-all” testing approach, as taken with CSV. CSA is also focused on critical thinking and requires some organizational change management to fully effect it in your environment.

In this webinar, you will learn just how to transition your validation work from classic Computer System Validation (CSV) to Computer Software Assurance (CSA), based on the 2022 draft guidance from the FDA, and now the final guidance issued in September 2025 for medical device companies, specifically in the areas of manufacturing and quality testing. You can increase the efficiency and effectiveness of software development life cycle (SDLC) activities, enabling the delivery and support of computer solutions and new innovative products that will drive the industry over the coming years.

This webinar is intended for those working in the FDA-regulated industries, focused specifically on medical device companies. However, CSA principles can be used for pharmaceutical, medical device software, and tobacco products if applied carefully to ensure you have documented evidence that is defensible.

You should attend this webinar if you are responsible for planning, executing, or managing the development, implementation, or validation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Learn by reviewing industry best practices and knowing where to gather key information to help you move forward with CSA and newer technologies and approaches quickly and in compliance with the FDA.

Learn how to complete a transition from CSV to CSA, including the policies, procedures, and other artifacts that will be needed.

Who Will Benefit?

• Manufacturing, Testing, Packaging, and Distribution companies in the following industries that are regulated by FDA are required to follow GDPs:
• Pharmaceutical
• Medical Device
• Software Companies Developing Medical Device Software and/or Software-as-a-Medical-Device (SaMD)
• Software vendors providing products & services to FDA-regulated industries
• Biologicals
• Tobacco
• Cannabis
• E-Liquid/Vapor
• E-Cigarette
• Cigar
• Third-party companies that support those in the above industries, including Contract Research Organizations (CROs)
• Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to the FDA.