Computer Validation: The GAMP 5 Approach

Computer Validation: The GAMP 5 Approach

Copenhagen, Denmark

Course No 17255




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If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail:


Frank Behnisch, CSL Behring GmbH
Yves Samson, Kereon
Dr Robert Stephenson, Rob Stephenson Consultancy


This is why you should attend this course:
  •  You will systematically be introduced to the principles and methods of the validation of computerised systems (according to GAMP®)
  •  You will learn the skills to plan, implement and document effectively validation activities for computerised systems and to assess them with respect to their GxP compliance
  •  You have the opportunity to practically apply the theoretical foundations in 6 workshops


Computerised systems are a central factor determining work sequences in the pharmaceutical industry. Their use increases product safety and saves time and costs of manual intervention. This creates the requirement and necessity, however, to validate all computerised systems which can influence the quality of pharmaceutical products.

The basis of the education course will be the current requirements for the validation of computerised systems like GAMP® and their GxP-oriented application in practice.

Experts from the pharmaceutical industry and from the GAMP® Committee will show you efficient ways to validate your computerised Systems.

Target Group

This course is directed towards specialists and executives in the pharmaceutical industry entrusted with the planning, implementation and evaluation of the validation of computerised systems.


Computer Validation: The GAMP 5 Approach

1st Day
Introduction – What the participants expect
An open session capturing the expectations of the delegates

Laws, Regulations and Guidelines for Computer Validation
  •  The historical perspective
  •  Current regulations and regulatory guidelines from  US
  •  New regulatory guidance (GAMP® 5, GAMP® Good Practice Guides, ASTM)
  •  New industry guidance
  •  Regulatory training
  •  Harmonisation
Electronic Records and Signatures
  •  What Part 11 means – Now!
  •  Identify e-records in predicate rules
  •  Identify risks to records
  •  Identify appropriate controls for records
The GAMP® 5 Approach to Computer Validation
  •  Validation needs structure
  •  The GAMP® approach
  •  What is new in GAMP® 5
  •  General validation activities
  •  The GAMP® Categorisation System
  •  Life Cycle cost reduction
The EU Annex 11 “Computerised Systems”
  •  What are the important points?
  •  How can you implement it?
User Requirements Specifications (URS)
  •  Why do we need user requirements and  specifications?
  •  What should a URS look like – and who should be involved?
  •  How to capture requirements effectively
  •  How does User Requirements documentation go wrong?
Risk Management
  •  Q9 process
  •  GAMP®5 five steps approach
  •  Practical approach to Risk Management
  •  High Level Risk Assessment – HLRA
  •  System Risk Assessment – SRA
  •  Functional Risk Assessment - FRA
2nd Day
Validation Planning
  •  Why is a validation plan important?
  •  Definitions and regulatory expectations
  •  Building risk management into planning phase
  •  Structure and contents of validation plans
  •  Discussion of best approach
  •  The impact of scalability
Specifications, Design Review and Traceability
  •  What sorts of specifications are needed?
  •  How are they constructed?
  •  Can they be combined?
  •  How to carry out a design review?
  •  How to construct a traceability matrix?
Protocols, Test Scripts and Deviation Management
  •  Principles of Risk-Based Qualification
  •  Leveraging the Supplier
  •  Commissioning vs Qualification
  •  Test Script Design
  •  Deviation Management
Change Control
  •  Regulatory requirements
  •  Configuration management
  •  Responsibilities
  •  Planned/unplanned changes
  •  Classification
  •  Sources of changes
3rd  Day
Automation Aspects
  •  System Overview / Specifications
  •  GAMP® and risk analysis
  •  Findings & consequences
Validation Reporting & Presentation to Inspectors
  •  The link between the plan and the report
  •  Key documents
  •  Validation summary reports
  •  Style and emphasis
  •  Managing the inspection
Regulatory Comments
  • Recent general trends
  •  Highlights from Warning Letters and 483s
  •  Lessons we must learn
Introduction to IT Infrastructure Qualification
  •  The qualification lifecycle
  •  How to deal with user requirements
  •  Qualification documentation
  •  Critical issues 
  • Qualification summary report
Workshop 1: Self Evaluation of Compliance with regulatory expectations

Workshop 2: Evaluation of a User Requirements Specification
A short review of the URS and how to write specifications, as a prelude to a workshop in which delegates will evaluate a real requirement specification
  •  What is a URS?
  •  Why is it important?
  •  Contents of a URS
  •  Characteristics of  good specifications
  •  Testable specifications
Workshop 3: Validation Planning
  • Based on considerations of the type of application, knowledge of the supplier and how it will be used, delegates will work out the best approach to delivering the benefits of a GxP system
  •  What are the risks associated with delivering the system?
  •  What options do you have to manage the most critical risks?
  •  How can they best be managed?
  •  What are the key issues to monitor to ensure delivery of the project benefits?
Workshop 4: Risk Management in Protocol Planning
Based on a real case study, delegates will use the same risk assessment techniques as in Workshop 2 to determine where to focus the qualification of a packaging line.
  •  Risk management applied to a control system
  •  Using FMEA to assess risks to be managed and controlled in validation
  •  Identifying options to mitigate (reduce) the higher risks
  •  Using the output in creating the testing protocol
Workshop 5: Managing Deviations
In this workshop examples of deviations will be examined and methods of resolution discussed. The examples are based on real-life protocols.
  •  Test failures found during IQ/OQ
  •  Manage the deviations
  •  Suggest solutions
  •  Using the output in creating the testing protocol
Workshop 6: Change Control
The participants will work on a number of case studies and define the change control activities needed.
  •  Change Control forms
  •  Approval process
  •  Standard Changes
  •  Committees

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