2019 - In-Depth Testing of Computer Systems Regulated by FDA

This course includes the following key areas of learning:
Determine the category of your system, based on GAMP 5 from ISPE
Determine the risks associated with the various ways your system may fail
Use the category and risk, develop a rationale for the level of testing that will be needed to assure your system is thoroughly vetted
Understand the FDA requirements for documentation of all testing activities
Understand how to write a test protocol for each phase of testing
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ) [also referred to as User Acceptance Testing, or UAT]
Understand how to develop test scripts and acceptance criteria
Learn how to identify test discrepancies and distinguish the type: test script errors, tester errors, system errors
Learn how to document all testing and the summary reports
Learn about maintaining the system in a validated state, and keeping testing as a ‘living’ exercise that runs through the system life cycle