Software and Automated System Validation
Description
This module will provide the student with knowledge of Validation of Software and Computerised / Automated Systems. The student will be introduced the key tasks and will be able to apply this knowledge as part of a validation team.
Learning Outcomes
Appreciate the regulators perspective on software and automated system validation, specifically for medical device manufacturing.
Recognize the growing dependency on software and automation in all aspects of medical device and other manufacturing from supply chain management, to laboratory data analysis; and the consequences thereof.
Particpiate as a quality or validation team member in Software Development Life Cycle (SDLC) projects utilizing the GAMP guidance.
Construct specification and verification documents and appreciate the importance of good requirements definition, traceability and test script structure.
Navigate and integrate the key supporting scaffolds to sucesssful software validation, including risk management, configuration management and change control.
Make robust data management decisions within validation projects, with respect to the growing industry dependence and regulatory emphasis on data integrity.