Computer System Validation
Duration: 60 Minutes
According to the FDA requirements 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). Computer system 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. In this computer system validation training you'll learn how to integrate risk based supplier evaluation into the computer system 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.
Objectives of the Presentation
Why Should you Attend
- Computer system validation life cycle models and Validation Plan contents
- How to determine the complexity category of your system based on GAMP 5 principles
- Guidelines on 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 computer system validation
- What requirements documentation is necessary
- How to plan and conduct IQ, OQ and PQ
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.
Who will Benefit
- Computer system validation strategy
- Requirements documentation
- Complexity and risk analysis
- Creating a detailed test plan based on risk
- Supplier qualification
- IQ, OQ and PQ
- Management responsible for operational and quality systems ("system owners")
- QA Directors, Managers and personnel
- IT / IS Managers and personnel
- Software Validation and Software Quality Managers + Personnel
- Consultants charged with creating or evaluating part 11 programs
- Programmers, developers, project managers and others responsible for bringing systems online in a compliant manner
- Quality auditors responsible for auditing and evaluating part 11 compliance