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Risk Based Computer System Validation

Event Details

Risk Based Computer System Validation

Time: April 1, 2019 from 1pm to 2pm
Location: Online
Website or Map:…
Phone: 717-208-8666
Event Type: webinar
Organized By: Compliance Key INC
Latest Activity: Mar 22

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Event Description


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.
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 should you attend this webinar?

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

Areas Covered in the Session:

  • Validation strategy

  • Requirements documentation

  • Complexity and risk analysis

  • Creating a detailed test plan based on risk

  • Supplier qualification

  • IQ, OQ, and PQ

Who can Benefit:

  • Computer system developers

  • Systems development engineers

  • QA/ QC

  • Lab Managers and Analysts

  • Production Managers

  • Engineering managers

Speaker Profile
Edwin Waldbusser is Keynote Speaker at ComplianceKey. He is retired from industry after 30 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. He now consults internationally in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis.

Contact Info:

Compliance Key



Phone: 717-208-8666

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