Course 5

Electronic data integrity for manufacturing

4 Modules | 4 hours

This online course on Electronic Data Integrity for Life Sciences Manufacturing consists of four modules. Module 500 introduces data integrity, the data life cycle, and corporate culture. Module 510 covers system validation, data governance, and IT systems. Module 520 discusses equipment types, risks associated with equipment data, and equipment best practices. Finally, Module 530 explores different application types in industry, risks associated with each system application, and controls and best practices to mitigate these risks.

This course offers

Module 500: Electronic data integrity in the Life Sciences industry

This module aims to:
1. Give you an introduction into Data Integrity in industry
2. Introduce you to the Data Life Cycle
3. Introduce you to the importance of appropriate corporate culture

The learning objectives for this module will allow you to:
1. Define ‘What is Data Integrity?’
2. Explain ALCOA+
3. Explain the Data Life Cycle

Module 510: Computer system validation

This module aims to:
1. Introduce you to system validation and its importance
2. Give you an introduction into Data Governance
3. Introduce you to IT systems and the risks and control measures associated with such systems

The learning objectives of this module are that you will be able to:
1. Explain what is validation and why it’s important to a company
2. Describe what is data governance
3. Explain the components and risks of an IT system

Module 520: Equipment considerations for data integrity

This module aims to:
1. Give you an introduction to the types of equipment in the life sciences industry
2. Introduce you to the risks associated with equipment data
3. Introduce you to some equipment best practices

The learning objectives for this module will allow you to:
1. Explain the different types of equipment
2. Explain the risks associated with equipment data
3. Describe the control measures that can be undertaken to mitigate data risks

Module 530: Application Types for Data Integrity

This module aims to:
1. Introduce you to the different application types in industry
2. Introduce you to the risks associated with each system application
3. Impart on you the controls and best practices used to mitigate these risks

The learning objectives of this module are that you will be able to:
1. Explain what an Enterprise/Local system application is
2. Describe the risks associated with an Enterprise/Local system
3. Describe the appropriate actions undertaken to mitigate inherent risks

IAAE seeks to credential 10,000 learners globally, and to engage 10 of the top 20 companies in each regulated health industry, by the end of 2035.

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