Risk Based Computer System Validation

FDA requires that all software in computer systems used in GxP activities be validated. The validation of computer system software is completely different from that of device software (embedded software). Verification 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. The validation of computer system software is entirely different from that 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.

AREAS COVERED IN THE SESSION:

• How to manage the validation process
• Validation life cycle models and Validation Plan contents
• How do you determine the complexity category of your system based on GAMP 5 principles
• How to evaluate risk level using GAMP 5 modifications the IS14971 procedure
• What level of testing is necessary based on software complexity and risk
• Integrating software supplier evaluation in the validation process
• What documentation is necessary
• how to minimize documentation reduces costs based on risk
• How plan and conduct IQ, OQ, and PQ

WHO SHOULD ATTEND:

• Computer system developers
• Systems development engineers
• Lab Managers and Analysts
• Production Managers
• Engineering managers
• Quality Assurance
• Regulatory Affairs
• Operations
• Engineers
• Quality Engineer
• QA/QC Professionals
• Engineering/Technical Service Professionals
• Consultants
• Operations and Manufacturing
• Compliance Professionals

Course Director: Edwin Waldbusser

Edwin Waldbusser retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/non-conforming product programs. He now consults in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis. 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.