Testing GxP Computerised Systems PDF  | Print |

Course Aims:

To provide participants with the necessary skills to plan, execute, review and approve testing of GxP computer systems. During this training session learners will be introduced to the key concepts of computer system testing as outlined by GAMP Good Practise Guide: Testing of GxP Systems. Participants will be shown how to use Risk Management to reduce testing effort, leading to more effective and efficient validations.

Course Content:

Key Concepts

  • Purpose of Testing
  • GAMP5 V Model
  • Validation, Verification, Qualification and Testing
  • Validation Framework for Categories 3, 4 and 5 Software

User and Supplier Considerations

  • Minimising User Testing using Risk Management
  • Roles and Responsibilities
  • Supplier Assessment

Test Policies

  • Types of Verification/Testing within the SDLC
  • Writing the Test Policy

Test Planning and Management

  • Writing the Test Plan
  • Test Management Considerations
  • Test Roles and Resources

Test Protocols

  • Requirements, Installation, Functional, Integration and Module Test Protocols
  • Test Plan – Test Protocol – Test Case – Test Script
  • Writing Test Documents
  • Dynamic Testing Techniques

Test Execution, Recording Results and Reviewing

  • Good Test Practice
  • Automated Test Tools

Test Reporting and System Handover

  • Writing Test Reports
  • Managing System Handover for Live Use

Testing in the Operational Phase

  • Change Control

Training Duration : 2 days

 

Training Methods: This workshop uses a combination of slide presentation and other multi-media to introduce key concepts. The course will also involve interactive discussion, practical examples and hands on test protocol generation and execution using an example GxP System.

 

Training Assessment: Each Learner will have a PC with an example GxP system for executing test protocols.

 

Target Trainee Profile: This course is aimed at personnel involved in the execution of Computerised System Validations including Quality, IT and others involved in the implementation and validation of GxP computer systems in the Pharmaceutical, Medical Device or Biotechnology Industries.

 

Public Course Cost : €700 per person includes course documentation, templates, lunch and refreshments

 

Note: This course can be arranged specifically for your company. Please contact us if we can assist you with any enquiries in regard to the next public course or if you would like us to arrange a course for you.
 
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