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.
During this webinar, the following areas will be covered:
- Computer System Validation (CSV)
- GAMP®5 “V” Model
- System Development Life Cycle (SDLC) methodology
- Validation Planning
- Validation Requirements
- Validation Testing
- Validation Reporting
- Requirements Traceability Matrix (RTM)
- Computer Software Assurance (CSA)
- Critical Thinking
- GAMP®5, 2nd Edition, and its alignment with CSA
- Transition from CSV to CSA
- 21 CFR Part 11 Guidance (ER/ES)
- 21 CFR Part 11 Requirements and Controls
- Common 21 CFR Part 11 Deficiencies
- Data Integrity Guidance (ALCOA+++ Principles)
- Data Integrity Requirements and Controls
- Common Data Integrity Deficiencies
- Data Life Cycle Management
- Data Governance
- Data Privacy
- Commercial-Off-the-Shelf (COTS) solutions
- Cloud Services
- Software-as-a-Service (SaaS) Solutions
- Platform-as-a-Service (PaaS) Solutions
- Infrastructure-as-a-Service (IaaS) Solutions
- Single-Sign-On (SSO)
- Vendor Audit
- Artificial Intelligence (AI)
- Machine Learning (ML)
- Large Language Models (LLMs), including ChatGPT
- Retrieval-Augmented Generation (RAG)
- Recursive Language Models (RLMs)
- FDA Regulatory Compliance
- Current FDA Regulatory Enforcement Trends
- FDA Inspection Types
- Internal Audit
- Industry Best Practices
- Q&A
The life science industries, including pharmaceutical, medical device, biotechnology, biological, 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). Automation has been used since the late 1970s, and in 1983, the FDA recognized the need to regulate such computer systems. This resulted in the FDA Guidance for Computer System Validation (CSV) in 1983. CSV is based on a System Life Cycle Development (SDLC) methodology, with prescribed activities and deliverables to be produced through the life of an FDA-regulated system.
By the early 1990s, the industry was seeking a pathway to go “paperless,” using electronic record and electronic signature (ER/ES) capability. The 21 CFR Part 11 Guidance was issued in 1997 to provide the requirements for ER/ES.
In 2002, the FDA recognized the need for a risk-based approach to validation, understanding that they could not audit every computer system at every company, as they were increasing exponentially. The risk-based approach became standard when performing validation.
In 2018, the FDA found an alarming rate of violations by life science companies related to CFR Parts 211 and 212. These rules had been in place for decades, but suddenly, the industry was failing at meeting them. The 2018 Data Integrity Guidance was issued and did not include a single new requirement. Instead, it reiterated the need for industry to improve its compliance in these key areas. It was a wake-up call for management and quality to provide organizations with a culture of accountability and an appropriate level of quality oversight.
In September 2022, the FDA issued a Draft Guidance for Computer Software Assurance (CSA), replacing the outdated CSV approach. CSV was document-centric and heavily manual, which required significant time and was prone to error. CSA offered a fresh approach based on critical thinking, an art that was lost over prior decades as automation took center stage, and provided they had validated a system, practitioners accepted the computer output. They had, in essence, become the “robots.” The International Society for Pharmaceutical Engineering (ISPE) issued GAMP5, 2nd Edition in July 2022, aligning the recommended approach with CSA. CSA became a final guidance in September 2025, but only for manufacturing and quality operations in medical device companies. The expectation is that this will become the standard approach for all life science industries in the near term. Until then, other markets and operational areas must continue to follow the CSV approach.
Since 2015, 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 applying computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance in environments where newer technologies are becoming prevalent.
Providing safe and effective pharmaceuticals, medical devices, and other FDA-regulated products is in the best interests of all those involved in the development, manufacturing, testing, and distribution of these products, as well as the customers/patients. You will learn about the FDA’s CSV and CSA approaches, where the latter will enable practitioners 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 the 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.
You will also learn about 21 CFR Part 11 (ER/ES), data integrity, data life cycle management, data privacy, and data governance.
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.
Personnel in the following roles will benefit:
- Information Technology (IT) Analysts
- IT Software Developers & Testers
- IT Support Staff
- IT Security Staff
- Production Managers and Supervisors
- Supply Chain Managers and Supervisors
- Clinical Data Managers and Scientists
- Contract Resource Organizations (CROs)
- Contract Development and Manufacturing Organizations (CDMOs)
- Compliance Managers and Auditors
- Quality Laboratory Managers and Analysts
- Quality Auditors
- Computer System Validation Specialists
- GMP, GLP, GCP Training Specialists
- Business Stakeholders Using Computer Systems Regulated by the FDA
- Regulatory Submissions and Regulatory Affairs Personnel
- Consultants in the Life Science Industries
- Interns working at the companies listed above
Companies in the following industries that are regulated by the FDA are required to follow GxPs:
- Pharmaceutical
- Medical Device
- Biologicals
- Tobacco
- Cannabis
- E-Liquid/Vapor
- E-Cigarette
- Cigar
- Software Companies Developing Medical Device Software and/or Software-as-a-Medical-Device (SaMD) Products
- Software vendors providing products & services to all operational areas of FDA-regulated industries
- 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, Regulatory Submissions, Regulatory Affairs, Manufacturing, Quality, and Supply Chain Functions related to the FDA
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