Risk Based Computer System Validation

Risk Based Computer System Validation


  Regulatory Consultant

Medical Device Advisors

  When : Tuesday, September 14, 2021

  Time : 01 : 00 PM EST

  Duration : 60 Minutes

  Product ID : EDWA-0037

  Level : Intermediate

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Ed retired from industry after 27 years in management of development of medical device products and development of company Quality Systems. He has been a consultant for the last10 years, working with companies from startups to Fortune 100 in the US, Germany, United Kingdom, Netherlands, Canada, Poland, and Saudi Arabia. He specializes in design control, risk analysis, human factors, software validation, cybersecurity and supplier qualification/ control. Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.

FDA requires that all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely different than the validation of device software (embedded software). Validation is much more than testing. It is testing plus design control and configuration management.

How to plan and conduct a risk-based validation will be explained. The overall risk for a computer system is a combination of software complexity and product risk as determined by probability, severity, and detectability rankings. Also involved in the risk evaluation is the requirement for purchased software supplier qualification. You’ll learn how to integrate risk-based supplier evaluation into the validation process.

The validation Master plan and System Validation Plans will be explained. Testing, based on risk, includes requirements validation and IQ, OQ, and PQ. A procedure for each level of complexity and risk will be described   

Learning Objectives 

  • Validation strategy
  • Requirements documentation
  • Complexity and risk analysis
  • Creating a detailed test plan based on risk
  • Supplier qualification
  • IQ, OQ, and PQ

Course Level - Basic and Intermediate

Who Should Attend   

  • Computer System Developers
  • Systems Development Engineers
  • QA/ QC
  • Lab Managers and Analysts
  • Production Managers
  • Engineering Managers

Why Should You Attend

Validation of computer system software is completely different than the validation of device software (embedded software). Attempting to conduct a CSV following device software validation concepts could result in a 483 or rejection of a product approval submission.

You will learn in detail:

  • How to manage the validation process
  • Validation life cycle models and Validation Plan contents
  • How to determine the complexity category of your system based on GAMP 5 principles
  • How to evaluate risk level using GAMP 5 modifications to the ISO 14971 procedure
  • What level of testing is necessary based on software complexity and risk
  • Integrating software supplier evaluation into the validation process
  • What documentation is necessary
  • How to minimize documentation to reduce costs based on risk
  • How to plan and conduct IQ, OQ, and PQ
  • $179.00

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