This module will provide the student with a solid understanding of the considerations around the use of data in industry and practical methods to define, protect and ensure the quality and integrity of that data.

1. Interpret electronic record & electronic signature regulatory requirements, e.g. US 21CFR Part 11 / EU Annex 11.

2. Transform these requirements into practical and useable procedures and tools for a pragmatic approach to regulatory compliance.

3. Identify electronic and paper-based records in use and the associated requirements for managing each.

4. Recognize the value of your data and understand the underpinning concepts of data integrity from an ALCOA and ALCOA+ perspective.

5. Appreciate the regulators / auditors perspective on data integrity from a paper based and electronic perspective.

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 andsystem boundary definition, with consideration to the various project types, includinglarge 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 enablethescaling ofvalidation 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. Analysetechnical specifications documents ensuring coverage of planned activities.

6. Critique verificationoutput documents to ensure requirement and test traceability.

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.

1. Appreciate the regulators perspectiveonsoftware and automated system validation, specifically for medical device manufacturing.

2. 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.

3. Particpiate as a quality or validation team member in Software Development Life Cycle (SDLC) projectsutilizing the GAMP guidance.

4. Construct specification and verificationdocuments and appreciate the importance of good requirements definition,traceability andtest script structure.

5. Navigate and integrate the key supporting scaffolds to sucesssful software validation, including risk management, configuration management and change control.

6. Make robustdata management decisionswithin validation projects,with respect to thegrowing industry dependence and regulatory emphasis on data integrity.

This module will provide a high level introduction to current and emerging trends in terms of the use of Software in Medtech. The use of industry guest lecturers will expose the students to real industry examples of these emerging trends and associated challenges.

1. Critically analysetheapplication of Software as a Medical Device (SaMD)

2. Discussthe implications of software making clinical decisions and remote monitoring of patient health.

3. Investigate recent developments in AI (Artificial Intelligence),Virtual Reality (VR) and Robotic Process Automation (RPA)and potential future directions.

4. Explain GMLP (Good Machine Learning Practice) and know how to embrace the rapid developments in machine learning.

5. Appreciate the regulators / auditors perspective on advancing application of software in the context of healthcare manufacturing.