Classic CSV vs CSA: validating systems vs assuring software quality.

Organizations can begin applying selected CSA principles immediately—even beyond the primary scope of the final guidance—provided they can clearly justify their approach and demonstrate alignment with 21 CFR Part 11, data integrity requirements, the Quality Management System (QMS), and other governing procedures.

This seminar presents a comprehensive overview of the evolution from traditional Computer System Validation (CSV) to Computer Software Assurance (CSA). Participants will receive a practical, step-by-step roadmap to support a successful transition within their organization. Key transition activities, required documentation, supporting artifacts, and common challenges will be discussed in detail.

A live Q&A session will be included. Additionally, the slide deck contains an appendix illustrating a real-world transition example using a LabWare Laboratory Information Management System (LIMS).

This example highlights the level of detail and documentation necessary to effectively shift from CSV to CSA while maintaining regulatory compliance.

Life sciences sectors-including pharmaceuticals, medical devices, biotechnology, biologics, and tobacco-related industries-continue adopting advanced technologies to improve product quality while maintaining FDA compliance. Automation has been in place since the late 1970s, prompting the FDA to issue its original Computer System Validation (CSV) guidance in 1983. CSV relies on a structured System Development Life Cycle (SDLC) model, requiring defined activities and documentation throughout a system’s lifecycle.

In the 1990s, the industry began transitioning toward paperless operations. This led to the issuance of 21 CFR Part 11 in 1997, establishing regulatory requirements for Electronic Records and Electronic Signatures (ER/ES).

By 2002, the FDA formally endorsed a risk-based validation approach, recognizing the rapid expansion of computerized systems across regulated organizations.

In 2018, the FDA observed a significant increase in compliance deficiencies related to CFR Parts 211 and 212. The resulting Data Integrity Guidance reinforced existing expectations without introducing new regulations, emphasizing accountability, oversight, and quality culture.

In September 2022, the FDA released Draft Guidance for Computer Software Assurance (CSA), signalling a shift away from the document-heavy CSV model. CSA emphasizes risk-based decision-making and critical thinking rather than excessive documentation. ISPE aligned with this shift through the publication of GAMP®5, 2nd Edition in July 2022. CSA became final guidance in September 2025 for medical device manufacturers in manufacturing and quality operations. Broader industry adoption is expected in the near future, while other sectors continue operating under traditional CSV expectations.

Since 2015, life sciences organizations have increasingly implemented cloud platforms, SaaS models, AI, ML, and LLM technologies such as ChatGPT. As digital transformation accelerates, ensuring validation, Part 11 compliance, and data integrity within these modern environments has become essential.

Learning Objectives

Participants will gain the ability to:

• Comprehend the foundational principles of traditional Computer System Validation (CSV)
• Examine the GAMP®5 “V” Model framework
• Understand the System Development Life Cycle (SDLC) approach
• Apply best practices in validation planning, requirements development, testing, reporting, and traceability
• Explore the CSA methodology and the importance of critical thinking
• Review GAMP®5, 2nd Edition and its alignment with CSA principles
• Develop a structured approach for transitioning from CSV to CSA
• Understand the fundamentals of 21 CFR Part 11 (Electronic Records/Electronic Signatures – ER/ES)
• Identify Part 11 compliance requirements and control expectations
• Recognize common Part 11 deficiencies cited during FDA inspections
• Strengthen understanding of data integrity principles and requirements
• Identify frequent data integrity gaps observed during FDA inspections
• Understand data lifecycle management concepts
• Appreciate the role of data governance and privacy requirements
• Evaluate Commercial-Off-the-Shelf (COTS) solutions and associated support considerations
• Understand cloud computing environments and support requirements
• Review Software-as-a-Service (SaaS) models and compliance considerations
• Understand how Platform-as-a-Service (PaaS) and Infrastructure-as-a-Service (IaaS) support streamlined development and deployment
• Implement and manage Single-Sign-On (SSO) capabilities
• Conduct effective vendor audits
• Understand Artificial Intelligence (AI) and Machine Learning (ML) fundamentals
• Review Large Language Models (LLMs), including ChatGPT
• Understand Retrieval-Augmented Generation (RAG) concepts
• Recognize how Recursive Language Models (RLMs) may extend beyond LLMs and RAG
• Review FDA’s evolving expectations regarding AI, ML, and LLM use
• Understand industry adoption trends for AI-driven technologies
• Gain insight into FDA regulatory compliance expectations
• Review current FDA enforcement trends
• Understand various FDA inspection types
• Conduct effective internal audits
• Apply industry best practices

Areas Covered

This session will address:

• Computer System Validation (CSV)
• GAMP®5 “V” Model
• System Development Life Cycle (SDLC)
• Validation Planning, Requirements, Testing, and Reporting
• Requirements Traceability Matrix (RTM)
• Computer Software Assurance (CSA)
• Critical Thinking in Validation
• GAMP®5, 2nd Edition alignment with CSA
• CSV-to-CSA Transition Methodology
• 21 CFR Part 11 (ER/ES) Guidance
• Part 11 Compliance Requirements and Controls
• Common Part 11 Deficiencies
• Data Integrity (ALCOA+++ Principles)
• Data Integrity Controls and Gaps
• Data Lifecycle Management
• Data Governance and Privacy
• COTS Solutions
• Cloud Services
• SaaS, PaaS, and IaaS Environments
• Single-Sign-On (SSO)
• Vendor Audits
• Artificial Intelligence (AI) and Machine Learning (ML)
• Large Language Models (LLMs), including ChatGPT
• Retrieval-Augmented Generation (RAG)
• Recursive Language Models (RLMs)
• FDA Regulatory Compliance
• Enforcement Trends and Inspection Types
• Internal Auditing
• Industry Best Practices
• Q&A

Why Should You Attend

Ensuring the safety and effectiveness of FDA-regulated products remains a shared responsibility across development, manufacturing, testing, and distribution functions.

This Seminar explains both CSV and CSA frameworks, highlighting how CSA enables more flexible, risk-based testing approaches suited to emerging technologies such as cloud platforms and SaaS environments. Unlike CSV’s standardized testing model, CSA promotes scalable validation activities driven by risk and critical thinking. Successful adoption requires thoughtful organizational change and leadership engagement.

Participants will learn how to transition validation programs from CSV to CSA in alignment with FDA’s 2022 draft and 2025 final guidance (for medical device manufacturing and quality operations). The session also explores how CSA improves SDLC efficiency while maintaining compliance.

Additional focus areas include 21 CFR Part 11, data integrity, data lifecycle management, governance, and privacy considerations.

This Seminar is designed primarily for professionals within FDA-regulated medical device organizations; however, CSA principles may be cautiously applied across pharmaceutical, tobacco, and software sectors when properly justified and documented.

Attend if you are responsible for implementing, managing, validating, maintaining, or auditing FDA-regulated computerized systems. Gain practical guidance, best practices, and actionable strategies to implement CSA while maintaining regulatory compliance.

Participants will also learn how to establish the necessary policies, procedures, and documentation required to support a successful CSV-to-CSA transition.

Who Should Attend

This program benefits professionals in roles such as:

• IT Analysts
• Software Developers and Testers
• IT Support and Security Teams
• Production and Supply Chain Managers
• Clinical Data Managers and Scientists
• CRO and CDMO Personnel
• Compliance Managers and Auditors
• Laboratory Managers and Analysts
• Quality Auditors
• Computer System Validation Specialists
• GMP, GLP, and GCP Training Professionals
• Business Stakeholders Using FDA-Regulated Systems
• Regulatory Affairs and Submissions Personnel
• Life Science Consultants
• Interns in FDA-regulated industries

Industries impacted include:

• Pharmaceutical
• Medical Device
• Biologics
• Tobacco and Related Products
• Cannabis and Vapor Products
• Software-as-a-Medical-Device (SaMD) Developers
• Software Vendors Serving FDA-Regulated Sectors
• Third-Party Service Providers (including CROs)
• Academic Institutions Offering FDA-Related Programs

Event Itinerary

Module 1: CSV, CSA, and GAMP®5 (2nd Edition) Alignment with CSA

(9:00 am - 10:00 am; 1 Hour)

Each Section Below - 5-10 Minutes

• Review of Classical Computer System Validation (CSV) Approach
• Review of GAMP®5 "V" Model
• Review of System Development Life Cycle (SDLC)
• Validation Planning, Requirements, Testing, Reporting, and Traceability
• Computer Software Assurance (CSA) Approach and Critical Thinking
• Review of GAMP®5, 2nd Edition and Alignment with CSA
• How to Transition from CSV to CSA

Module 2: 21 CFR Part 11 - Electronic Records/Electronic Signatures (ER/ES)

(10:00 am - 10:30 am; 30 Minutes)

Each Section Below - 15 Minutes

• 21 CFR Part 11 Guidance (ER/ES) Overview
• 21 CFR Part 11 Requirements & Controls

BREAK

(10:30 am - 10:40 am; 10 Minutes)

Module 3 - Continued

(10:40 am - 11:00 am; 20 Minutes)

Section Below - 20 Minutes

• 21 CFR Part 11 Deficiencies

Module 4: Data Integrity and Governance

(11:00 am - 12:00 pm; 1 Hour)

Each Section Below - 10 Minutes

• Data Integrity Guidance Overview
• Data Integrity Requirements & Controls
• Data Integrity Deficiencies
• Data Life Cycle
• Data Governance
• Data Privacy

Lunch Break

(12:00 pm - 1:00 pm; 1 Hour)

Module 5: Commercial Off-the-Shelf (COTS), Cloud, SaaS

(1:00 pm - 2:00 pm; 1 Hour)

Each Section Below - 10 Minutes

• COTS Solutions & Support
• Cloud Services & Support
• SaaS Solutions & Support
• PaaS & IaaS
• Single-Sign-On (SSO) Capability
• Vendor Audit

Module 6: AI, ML, & LLMs

(2:00 pm - 2:30 pm; 30 Minutes)

Each Section Below - 5-10 Minutes

• Artificial Intelligence (AI) & Machine Learning (ML) Concepts
• Large Language Models (LLMs), including ChatGPT
• Retrieval-Augmented Generation (RAG)
• Recursive Language Models (RLMs)

BREAK

(2:30 pm - 2:40 pm; 10 Minutes)

Module 7 - Continued

(2:40 pm - 3:00 pm; 20 Minutes)

Each Section Below - 10 Minutes

• FDA Focus on Use of AI, ML, & LLMs
• Industry Focus on Use of AI, ML, & LLMs

Module 8: FDA Trends in Compliance & Enforcement

(3:00 pm - 4:00 pm; 1 Hour)

Each Section Below - 30 Minutes

• FDA Regulatory Compliance
• FDA Regulatory Enforcement Trends

Module 9: Inspection Readiness

(4:00 pm - 4:45 pm; 45 Minutes)

Each Section Below - 15 Minutes

• FDA Inspection Types
• Internal Audit
• Industry Best Practices

Q&A

(4:45 pm - 5:00 pm; 15 Minutes)

Speaker Details

Carolyn Troiano brings more than 45 years of experience across pharmaceutical, medical device, tobacco, and other FDA-regulated industries. She has supported numerous major organizations in the United States and Europe, developing and implementing regulatory compliance strategies. Her expertise includes Computer System Validation (CSV), Computer Software Assurance (CSA), SDLC methodologies (both waterfall and agile), GAMP®5 2nd Edition, 21 CFR Part 11 compliance, Electronic Records and Electronic Signatures (ER/ES), Data Integrity, and Data Privacy. Carolyn has led the implementation and validation of large-scale, enterprise-wide systems across multiple GxP environments. She provides industry training through webinars and seminars and offers consulting services to life science organizations worldwide.

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