Computer System Validation

Wednesday September 19th 2018

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

   How to plan and conduct a risk based validation will be explained. Overall risk for 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. 

   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. 

Why ?

   Validation of computer system software is completely different than 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: 

   • 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 requirements documentation is necessary

   • How to plan and conduct IQ, OQ and PQ 

Areas Covered in the Session : 

   1. Validation strategy

   2. Requirements documentation

   3. Complexity and risk analysis

   4. Creating a detailed test plan based on risk

   5. Supplier qualification

   6. IQ, OQ and PQ

Who Will Benefit: 

   • Computer system developers

   • Systems development engineers

   • QA/ QC

   • Lab Managers and Analysts

   • Production Managers

   • Engineering managers

About Speaker: 

   Edwin Waldbusser retired from industry after 20 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/ non-conforming product programs.

   Edwin Waldbusser 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.

Event URL:

Organizer: Compliance Training Panel



Phone: 844-216-5230

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Starts: Wednesday, September 19th 2018 at 1:00pm
Ends: Wednesday, September 19th 2018 at 2:00pm

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Timezone: US/Eastern
Bookings close: September 19th 2018

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This event is organized by Compliance Training Panel.

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