Three-day Virtual Computing System Validation Course for Cloud and COTS Applications, March 2-4, 2022 | News

DUBLIN, February 18, 2022 /PRNewswire/ — “Computer System Validation for Cloud and COTS Applications” training has been added to from offer.

Advances in technology have forced organizations to rethink their business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers who are better informed and have higher expectations than ever. Work practices and tools must evolve to meet these challenges.

The approach to software development, validation, and maintaining a system in a validated state throughout its lifecycle must be carefully considered to meet changing needs. This webinar will include a comparison of agile and waterfall methodologies, along with the pros and cons of each. There may not be one size that fits all, and so it’s important to understand what needs to be considered when making such a determination.

We’ll also cover COTS, SaaS, IaaS, PaaS, and cloud services, outlining the benefits and risks of each model. In discussing these hardware and software options, we will include best practices for meeting FDA requirements for validation, 21 CFR Part 11, where applicable, and data integrity. Part of the session will identify current FDA concerns and how to ensure your systems will meet their expectations.

Why should you attend

The attendee will learn about the FDA’s approach to technology modernization and how it will benefit both the Agency and industry. We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV) using automated testing tools that will result in continuous validation of software products. This approach lends itself to agile software development methodology, which can be adapted for use in validation. We’ll discuss the pros and cons of each approach, as well as industry best practices for success.

We will cover Computer-Off-the-Shelf (COTS), Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), Platform-as-a-Service (PaaS) and services in cloud. You’ll learn how to select an optimal solution and ensure that, regardless, you can create a contract and service level agreement (SLA) that best suits your environment and needs.

Areas covered

  • Learn to identify “GxP” systems
  • Learn about the FDA’s current thinking on technology and software development, and its impact on the industry
  • Discuss the current state of the Computer System Validation (CSV) approach based on FDA requirements
  • Learn about the System Development Life Cycle (SDLC) approach to validation and how it can be modernized with a more agile approach, including automated testing for continuous validation
  • Learn more about cloud services and cloud service providers to optimize your experience
  • Learn how to validate in the cloud without compromising quality or compliance
  • Discover the pros and cons of an agile or waterfall approach
  • We will discuss cloud computing and Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), and Platform-as-a-Service (PaaS) systems that can be effectively adopted and validated.
  • Discuss best practices for documenting IT system validation efforts, whether using a waterfall or agile approach, including requirements, design, development, testing, and operational maintenance procedures, including means improve the effectiveness and efficiency of related documentation management
  • Understand the best approach to installation qualification (IQ) testing when system components are not on-premises, but in the cloud
  • Understand how to maintain a system in a validated state throughout the system lifecycle in a more cost-effective manner, by applying an Agile continuous validation approach
  • Learn how to ensure the integrity of the data that supports GxP work, despite changes and advances in new technologies
  • Discuss the importance of FDA-compliant “GxP” documentation
  • Learn about the policies and procedures needed to support your validation process and the ongoing maintenance of your systems in a validated state
  • Know the regulatory influences driving current FDA thinking at any given time
  • Finally, understand industry best practices that will allow you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the lifecycle. data life.
  • Questions and answers

Main topics covered:

Day 1

Module 1: CSV Methods and Templates

  • GxP systems
  • Computer System Validation (CSV)
  • Common SDLC Methodologies
  • Model GAMP5 “V”
  • Computer System Validation (CSV) vs Computer Software Assurance (CSA)
  • Critical mind
  • Waterfall vs. Agile

Module 2: Software and Services

  • Off-the-Shelf (COTS) Computer Software
  • FDA “Case for Quality”
  • Cloud systems
  • Software as a Service (SaaS)
  • Platform as a Service (PaaS) and 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

Module 3: CSV Planning

  • Validation Strategy Document (VSD)
  • Validation Strategy Components
  • Justification of validation tests
  • Categorization of the GAMP5 system
  • 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 Specification/Configuration Management (SDS/CMS)
  • Exercise: Application and design

Day 2

Module 5: Planning and Executing IQ, OQ, PQ Tests

  • IQ, OQ, PQ Purpose and content
  • Running CSV tests
  • CSV test summary report

Module 6: Testing and Validation Reports

  • Purpose and Content of the Requirements Traceability Matrix (RTM)
  • Purpose and Content of the Validation Summary Report (VSR)
  • Notification of acceptance and publication of the system

Module 7: CSV Operations and Maintenance

  • Maintain a system in a validated state
  • Disaster recovery planning
  • Business Continuity Planning
  • Records retention
  • System retirement challenges
  • Legacy systems and integration
  • Data migration

Module 8: CSV Support Components

  • Good Documentation Practices (GDP)
  • Training
  • Organizational Change Management (OCM)
  • CSV policies and procedures

Day 3:Module 9: Managing FDA Regulated Data

  • 21 CFR Part 11 Guidelines
  • Requirements for Electronic Records/Signatures (ER/ES)
  • Data lifecycle approach
  • Data integrity
  • Data governance

Module 10: Supplier Audit

  • Preparation for audits
  • Execution of audits
  • Post-audit

Module 11: FDA Trends

  • Regulatory influences
  • Regulatory trends
  • Current trends in compliance and enforcement

Module 12: Preparation for the inspection

  • Preparation for FDA inspections
  • Industry Best Practices

Module 13 CSV Exercises

  • Exercise 1: CSV
  • Exercise 2: Writing the Validation Master Plan (VMP)
  • Exercise 3: FDA Requirements for ER/ES
  • Exercise 4: Interviews and writing URS/FRS
  • Exercise 5: Writing an IQ, OQ, PQ test protocol
  • Exercise 6: Writing RTM
  • Exercise 7: Be the consultant

For more information on this training visit

Media Contact:

Research and Markets

Laura Woodsenior

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SOURCE Research and Markets

Gordon K. Morehouse