Developing a Strategic Approach to FDA Compliance for Computer Systems

Carolyn Troiano
From: Jun 16, 2022 - To: Dec 31, 2022
Recorded Webinar


Effective and compliant computer system validation is critical to any FDA-regulated organization. During the past 30 years, best practices have been developed and, if followed, can ensure laboratory computer systems are validated efficiently and in compliance with FDA regulations. This webinar will guide planning, executing, and validating a laboratory computer system, and managing the system in a validated state through the end of the system life cycle.

The course will address roles and responsibilities, the timing of phases and deliverables, business process reengineering, organizational change management, change control, audit trails, training, and documentation. You will learn what is required not only to validate your laboratory system but maintain it in a validated state until it is retired or otherwise no longer in use.

There is an enormous body of documentation and information available on computer system validation, which can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective methods, techniques, and tools available.

Areas Covered:-

  • System Development Life Cycle (SDLC) Methodology
  • Computer System Validation (CSV)
  • Good “Variable” Practice (GxP)
  • Good Manufacturing Practice (GMP)
  • Good Laboratory Practice (GLP)
  • GAMP 5 Guidance for System Classification
  • Risk Assessment
  • Risk Management
  • Validation Strategy
  • Change Control and Audit Trails
  • User Requirements Specification (URS) & Functional Requirements Specification (FRS)
  • System Design Specification (SDS) and System Configuration Specification (SCS)
  • Test Planning, Execution, and Documentation (IQ/OQ/PQ)
  • Requirements Traceability Matrix (RTM)
  • System Acceptance, Release Notification, and Deployment
  • System Retirement
  • Data Governance Archival

Learning Objectives:-

  • To describe how to identify “GxP” Systems.
  • To discuss the Computer System Validation (CSV) approach based on FDA requirements.
  • To discuss the System Development Life Cycle (SDLC) approach to validation.
  • To determine how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11.
  • To comprehend the risk-based validation techniques and how to leverage these techniques to create efficient yet compliant validation approaches.
  • To discuss appropriate validation strategies for many types of applications, including Cloud/SaaS, COTS, spreadsheets, and custom-developed systems. 
  • To become aware of best practices and inspector expectations for computer system validation and software quality assurance (SQA) programs.
  • To discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing, and operational maintenance procedures.
  • To determine how to maintain a system in a validated state through the system’s entire life cycle.
  • To describe how to assure the integrity of data that supports GxP work.
  • To discuss the importance of “GxP” documentation that complies with FDA requirements.
  • To discuss the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state.
  • To discuss the regulatory influences that lead to FDA’s current thinking at any given time.
  • To discuss how to conduct a risk assessment on computer systems that will provide the basis for developing a validation rationale.
  • To explain the need to include an assessment of a computer system’s size, complexity, business criticality, GAMP 5 category, and risk, should it fail, develop a cohesive and comprehensive validation rationale.
  • To determine how to best prepare for an FDA inspection or audit of a GxP computer system.
  • To describe the importance of performing a thorough vendor audit to ensure oversight of the products and services they deliver.
  • To discuss 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.

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