Computer System Validation Online Professional Certificate Program, August 23-27, 2021 –


DUBLIN – (COMMERCIAL THREAD)–The “Computer system validation training camp” training has been added to offer.

Computer System Validation Professional Certificate Program

A course designed to fully immerse you in computer system validation. This course provides an understanding of the regulations affecting your systems and hands-on practice in writing validation documents. You will leave ready to lead efficient, effective and inspection-ready validation projects.

The training camp is difficult and stimulating. This is a full five-day immersion in the validation process. Participants will work in focused teams to perform practical validation activities through instructions, exercises and case scenarios. The course progresses quickly and participants will change gears often to maintain a high interest and accommodate multiple learning styles. A balance of lectures, reading materials, exercises, and case studies keeps energy levels high and challenges participants.

Our training approach

We have designed a computer system validation course that not only meets the expectations of the FDA, ICH and Eudralex for risk-based validation, but also prepares you to implement these practices in your business. . Standard operating procedures and validation models used in the classroom have already proven their worth in other companies. We focus on your understanding and application of CSV techniques which will result in efficient, effective and inspection ready validation initiatives.

What you get

  • Understanding of how the CSV process fits into your software lifecycle (SDLC or SALC) and the purpose of each validation deliverable

  • Hands-on practice for creating key validation deliverables, including validation plans, requirement specifications, test plans, validation tests (IQ, OQ, PQ), trace matrices, test summaries, and validation reports

  • Best practices for running validation tests, documenting, and handling errors

  • Understanding of what the software requires and does not require validation

  • Methodology and implementation model for a risk-based approach to CSV

  • Details on how to leverage risk-based decision making in your software quality assurance procedures

  • Understanding of the key components and principles of a software quality assurance (SQA) program and auditor’s expectations

  • Understanding of major FDA and international regulations and guidelines regarding CSV that apply to your business

  • Current data and 9 years of trends on the most common FDA warnings for software validation and system quality

  • BONUS: Course registration includes 23-hour instructor-led online training, electronic copy of course workbook, CSV exam, and CSV certification.

Main topics covered:


Module 1: FDA Compliance

  • Therac Case Study 25

  • Courses for today

  • Impact on CSV regulations

  • FDA predicate rules

  • FDA Compliance and Enforcement

  • FDA inspection

  • FDA Compliance Tool Set

  • FDA Form 483

  • FDA warning letter


  • Eudralex Annex 11, 20 and III

  • ICH Guidelines

  • PIC / S Guides

  • Exercise: Explore the regulations

  • Exercise: Use

  • Quiz: FDA Guidelines

Module 2: CSV Methods and Templates

  • GxP Systems

  • Computer system validation (CSV)

  • Validation, verification and qualification

  • Common SDLC Methodologies

  • Model GAMP 5 “V”

  • Computer System Validation (CSV) vs Computer Software Assurance (CSA)

  • Cascade Methodology vs. Agile


Module 3: CSV Planning

  • Validation Strategy Document (VSD)

  • Components of the validation strategy

  • Justification of validation tests

  • Categorization of the GAMP 5 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 / Configuration Management Specification (SDS / CMS)

  • Exercise: Application and design

Module 5: Planning and Execution of IQ, QO, PQ Tests

  • IQ, OQ, PQ Purpose and content

  • Running CSV tests

  • CSV test summary report

Module 6: Test and validation reports

  • Requirements traceability matrix (RTM) Purpose and content

  • Validation summary report (VSR) Purpose and content

  • System acceptance and version notification


Module 7: CSV Operations and Maintenance

  • Maintain a system in a validated state

  • Planning for disaster recovery

  • Business continuity planning

  • Record keeping

  • Challenges of System Removal

  • Legacy systems and integration

  • Data migration

Module 8: CSV Support Components

  • Good Documentation Practices (BPD)

  • Coaching

  • Organizational Change Management (OCM)

  • CSV policies and procedures

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: Software and Services

  • Standard computer software (COTS)

  • The FDA’s “Quality Case”

  • 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 applications

  • Validation of the worksheet

Module 11: Supplier audit

  • Preparing for the audit

  • Performing the audit

  • Post audit

Module 12: FDA Trends

  • Regulatory influences

  • Regulatory trends

  • Critical mind

  • Current trends in compliance and enforcement


Module 13: Preparation for the inspection

  • Preparing for FDA inspection

  • Industry best practices

Module 14: CSV exercises

  • Exercise 1: CSV

  • Exercise 2: Writing the Validation Master Plan (VMP)

  • Exercise 3: FDA Requirements for ER / ES

  • Exercise 4: URS / FRS interviews and writing

  • Exercise 5: Writing the IQ, OQ, PQ test protocol

  • Exercise 6: Writing RTM

  • Exercise 7: Be the consultant

  • Preparation for the final exam

  • Final exam at home

For more information on this training, visit


Gordon K. Morehouse