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:

  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 of this module are that you will be able to:

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

510: Computer system validation (1 hour)

Module: 510

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

520: Equipment considerations for data integrity (1 hour)

Module: 520

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
Equipment Data Integrity Controls

Module 530: Application Types for Data Integrity (1 hour)

Module: 530

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

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