Course 5
ELECTRONIC DATA INTEGRITY FOR LIFE SCIENCES MANUFACTURING
(4 MODULES, 4 HOURS TOTAL)
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“The wide breadth of content offered by the IAAE® yields an opportunity to increase capability across a commensurately diverse set of functional groups and raise the tide for all boats.”
- Dan Kim, Director, Automation & Digital Operations, PSC Biopharmaceuticals with GSK
Course 5 Overview
This online course consists of four modules as described and illustrated below.
500: Electronic data integrity in the Life Sciences industry (1 hour)
Module 500
This module aims to:
- Give you an introduction into Data
Integrity in industry - Introduce you to the Data Life Cycle
- Introduce you to the importance of appropriate corporate culture
The learning objectives of this module are that you will be able to:
The learning objectives for this module will allow you to:
- Define ‘What is Data Integrity?’
- Explain ALCOA+
- Explain the Data Life Cycle
510: Computer system validation (1 hour)
Module: 510
This module aims to:
- Introduce you to system validation and its importance
- Give you an introduction into Data Governance
- 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:
- Explain what is validation and why
it’s important to a company - Describe what is data governance
- Explain the components and risks of an IT system
520: Equipment considerations for data integrity (1 hour)
Module: 520
This module aims to:
- Give you an introduction to the types of equipment in the life sciences industry
- Introduce you to the risks associated with equipment data
- Introduce you to some equipment best practices
The learning objectives for this module will allow you to:
- Explain the different types of equipment
- Explain the risks associated with equipment data
- Describe the control measures that can be undertaken to mitigate data risks
Module 530: Application Types for Data Integrity (1 hour)
Module: 530
This module aims to:
- Introduce you to the different application types in industry
- Introduce you to the risks associated with each system application
- 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:
- Explain what an Enterprise/Local
system application is - Describe the risks associated with an Enterprise/Local system
- Describe the appropriate actions undertaken to mitigate inherent risks
