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
- Access from any device
- Certificate of completion
- 4 hours online course content
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
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
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
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
