Overview:
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.
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.
Who Should Attend
- Computer System Developers
- Systems Development Engineers
- QA/ QC
- Lab Managers and Analysts
- Production Managers
- Engineering Managers
