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2 Day Online Course: Introduction to Computer System Validation (March 27-28, 2023)
[January 24, 2023]

2 Day Online Course: Introduction to Computer System Validation (March 27-28, 2023)

DUBLIN, Jan. 24, 2023 /PRNewswire/ -- The "Introduction to Computer System Validation" training has been added to's offering.

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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.

We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.

We'll talk about CSA and how to validate cloud, COTS, SaaS, and other systems and maintain them in a validated state. This will include a discussion around waterfall, agile, and other methodologies for system development, testing, and validation, including how to apply automated testing to your approach.

We will also walk through the entire set of essential policies and procedures, as well as other supporting documentation and activities that must be developed and followed to ensure compliance. We will provide an overview of practices to prepare for an FDA inspection, and will also touch on the importance of auditing vendors of computer system hardware, software, tools and utilities, and services.

Finally, we will provide an overview of industry best practices, with a focus on data integrity and risk assessment that can be leveraged to assist in all your GxP work.

CSV Training Overview

FDA's recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that "touch" product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA.

All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.It is a risk-based approach to Computer System Validation (CSV) and maintenance of a system in a validated state that leads to the best results and compliance with FDA's expectations.

Why Should You Attend

This seminar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do, and a key element is a thorough risk assessment.

It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception throug retirement, making it critical to continue assessing risk as changes are made. We will discuss the phases within the SDLC, and how these form the basis for any CSV project. The importance of the sequence of steps will also be covered.

We will also cover the recent draft guidance from FDA on Computer Software Assurance (CSA), which is based on critical thinking in approach. We'll talk about agile vs. waterfall, automated testing, Cloud, COTS, and Software-as-a-Service. We'll also touch on 21 CFR Part 11, FDA's guidance on electronic records/signatures to discuss the importance of including aspects of er/es technology during validation and maintenance of a system.

Learning Objectives

  • Learn how to identify "GxP" Systems
  • Discuss the Computer System Validation (CSV) approach based on FDA requirements
  • Learn about the System Development Life Cycle (SDLC) approach to validation
  • Learn about COTS, cloud, SaaS and other types of systems and how they can be validated and maintained in a validated state.
  • Understand FDA's new draft guidance on Computer Software Assurance (CSA) and how to apply this to your approach to validation, focusing on critical thinking.
  • Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
  • Understand how to maintain a system in a validated state through the system's entire life cycle
  • Learn how to assure the integrity of data that supports GxP work
  • Discuss the importance of "GxP" documentation that complies with FDA requirements
  • Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
  • Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures
  • Know the regulatory influences that lead to FDA's current thinking at any given time
  • Learn how to conduct a risk assessment on computer systems that will provide the basis for developing a validation rationale
  • Understand the need to include an assessment of a computer system's size, complexity, business criticality, GAMP 5 category and risk, should it fail, to develop a cohesive and comprehensive validation rationale
  • Learn how to assess risk, based on probability of occurrence, severity of impact, detectability and mitigation, along with technical and procedural controls that can help minimize risk
  • Learn how to best prepare for an FDA inspection or audit of a GxP computer system
  • Understand the importance of performing a thorough vendor audit to ensure oversight to the products and services they deliver
  • Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
  • Q&A



01:00pm - 02:00pm:

Module 1:CSV Methods and Models

  • GxP Systems
  • Computer System Validation (CSV)
  • Common SDLC Methodologies
  • GAMP5 "V" Model
  • Computer System Validation (CSV) vs. Computer Software Assurance (CSA)
  • Critical Thinking
  • Waterfall vs. Agile Methodology

Module 2:Software and Services

  • Computer Off-the-Shelf (COTS) Software
  • FDA's "Case for Quality"
  • Cloud Systems
  • Software as a Service (SaaS)
  • Platform as a Service (PaaS) & Infrastructure as a Service (IaaS)
  • Single Sign On (SSO)
  • Medical Devices and Software as a Medical Device (SaaMD)
  • Mobile Devices and Medical Application
  • Spreadsheet Validation

2:00pm-2:10pm - 10 min Break


Module 3: CSV Planning

  • Validation Strategy Document (VSD)
  • Validation Strategy Components
  • Rationale for Validation Testing
  • GAMP5 System Categorization
  • Risk Assessment
  • Risk Mitigation
  • Exercise: Risk Assessment

Module 4:System Requirements and Design

  • Requirements Development
  • User Requirements Specification (URS)
  • Functional Requirements Specification (FRS)
  • System Design/Configuration Management Specification (SDS/CMS)
  • Exercise: Application and Design

3:50pm-4:00pm - Q&A



Module 5:IQ, OQ, PQ Test Planning & Execution

  • IQ, OQ, PQ Purpose and Contents
  • CSV Test Execution
  • CSV Test Summary Report

Module 6:Test and Validation Reports

  • Requirements Traceability Matrix (RTM) Purpose and Contents
  • Validation Summary Report (VSR) Purpose and Contents
  • System Acceptance and Release Notification

Module 7: CSV Operations and Maintenance

  • Maintaining a System in a Validated State
  • Disaster Recovery Planning
  • Business Continuity Planning
  • Record Retention
  • System Retirement Challenges
  • Legacy Systems and Integration
  • Data Migration

Module 8:CSV Supporting Components

  • Good Documentation Practices (GDPs)
  • Training
  • Organizational Change Management (OCM)
  • CSV Policies and Procedures


Module 9:Managing FDA-Regulated Data

  • 21 CFR Part 11 Guidance
  • Electronic Records/Signatures (ER/ES) Requirements
  • Data Life Cycle Approach
  • Data Integrity
  • Data Governance

Module 10: Vendor Audit

  • Audit Preparation
  • Audit Execution
  • Post-Audit


Module 11:FDA Trends

  • Regulatory Influences
  • Regulatory Trends
  • Current Compliance and Enforcement Trends

Module 12:Inspection Preparation

  • FDA Inspection Readiness
  • Industry Best Practices

4:50pm-5:00pm - Q&A

Additional material that can be read through and completed off-line after the presentation is completed:

  • CSV Exercises (These can be done after the session)
  • Exercise 1:CSV
  • Exercise 2:Validation Master Plan (VMP) Writing
  • Exercise 3:FDA Requirements for ER/ES
  • Exercise 4:Interviews and URS/FRS Writing
  • Exercise 5:IQ, OQ, PQ Test Protocol Writing
  • Exercise 6:RTM Writing
  • Exercise 7:Be the Consultant


Carolyn Troiano
Webinar/Seminar/Workshop Instructor in FDA Compliance Training

Carolyn Troiano has more than 35 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

For more information about this training visit

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