Managing Validation Projects

This module will provide the student with the specific knowledge of how to add value to and successfully manage a software or automated validation project and ensure result delivery in the medical device manufacturing context.

1. Formulate validation project scope and system boundary definition, with consideration to the various project types, including large validation projects, e.g. ERP system validation.

2. Construct a validation plan and validation summary report.

3. Conduct risk management activities, including risk identification, to enable the scaling of validation effort based on product /patient risk, as a key input to validation planning.

4. Appreciate the role of communication and stakeholder buy-in within any project, specifically a CS Validation project.

5. Analyse technical specifications documents ensuring coverage of planned activities.

6. Critique verification output documents to ensure requirement and test traceability.