Computer Systems Validation Master Class

Computer Systems Validation Master Class

Barcelona, Spain

Course No 15063


This conference already took place.

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


Frank Behnisch, CSL Behring, Germany
Maik Guttzeit, GEA Lyophil, Germany
Dr David Selby, Selby Hope International, UK
Dr Rob Stephenson, Rob Stephenson Consultancy, UK


As a specialist for the validation of computerised systems, this event will provide you with
Suggestions on how the current regulatory developments have to be put into practice
Real-life examples of how the validation efforts can be controlled by means of risk analysis
Answers to specific questions, like e.g. on source code review or on drawing up design specifications
The opportunity to bring questions from your own practice up for discussion

The event is interactive and encourages the active participation of all attendees. Lectures alternate with workshops and discussion sessions.


The V model has become a worldwide standard in the validation of computerised systems. Regulatory requirements as well as industry standards, like e.g. GAMP®, are orientated towards this model. In practice, you as a validation specialist will often wonder in how far this model can be applied to your own validation projects.

Target Group

The Master Class is directed at employees from
Quality Assurance
Quality Control
The participants should already have experience in the validation of computerised systems and preferably to have attended the Basic CSV Course.


Introduction – Gain Understanding of Delegate Experience and Background
An open tutor-led session to introduce everyone and enable the tutors to understand the background and experience of the delegates.

Roles, Responsibilities and Governance
In GAMP® 5 the emphasis on Good Engineering practices has shifted some responsibilities especially in relation to QA
Activities for Effective Governance
Process and System Ownership
The role of Subject Matter Experts
The role of QA

Writing Requirements Documents
An introduction to writing requirements documents, particularly the do’s and don’ts.
What goes into a requirements document?
What are the considerations for systems?
Characteristics of good and bad requirements documents
Sources of requirements information

Practical Use of Scalability
GAMP® 5 emphasises the importance of “Scalability of approach” in planning validation activities, and particularly the documentation, to the size of the project and the risk to the patient. This presentation will discuss a scaled approach
What do we mean by Scalability?
How does it work in practice?
How can we combine documents successfully?
How much is enough?

More about Risk Management
A review of the finer points of FMEA and the implications of the different approaches that are possible from the GAMP® 5 perspective.
What is really important in managing risk?
How do you set the “threshold of acceptable risk”?
The importance of Risk Registers
How to document risk management for benefit

Upcoming Challenges in IT
IT is a fast developing industrial sector. What is the impact of new developments on GMP / on computer systems validation? Attendees can select 3 of the following topics which will be discussed intensively
Open source software
Global systems
Paperless Production: EBR with Vertical Integration
Cloud Computing / Virtualisation
Infrastructure Qualification / ITIL

hange Control and Configuration Management
The session will provide practical guidance on the set-up of a change control procedure covering computerised systems.
Regulatory requirements
Configuration management
Planned/unplanned changes
Sources of changes

Validating Spreadsheets
A review of the approaches to the validation of spreadsheets, including their development
Why are spreadsheets high risks?
Design considerations
What is important (risk again)!
How to document spreadsheet validation

Risk Management and Electronic Records
An introduction to the application of the science- and risk-based approach to the control applied to electronic record. The presentation will emphasise the principles to be applied and the methods to decide on the most appropriate controls to apply.
A clear definition of electronic records with examples
An overview of the principles of risk management applied to the classification of electronic records
When is an audit trail needed
Do we need to keep chromatographic (and other) raw data?
Examples of the application of controls
Impact of the approach on validation of e-record systems

Code Review
Principles of code review
Regulatory expectations of code review
Carrying out code reviews
Recording and documenting code reviews

Handover – the Process and Package
This final session will look at the issues associated with handover and the maintenance of the validated state when the system is in the productive environment.
What is the handover process?
Who is the system owner?
What does the system owner have responsibility for?
How can we persuade the system owners to accept responsibility?

Workshop 1: What the Delegates expect
Working in groups delegates derive their requirements from the training event and share them with the tutors
Capturing delegates expectations
Sharing and reducing to key points in groups
Sharing with all delegates and tutors

Workshop 2: Implications for your Organisation
How does the GAMP® 5 approach change the way we carry out and control our validation/verification activities? Who will be impacted by the changes?
What is the role of
Subject matter experts

Workshop 3: Writing a Requirement Specification
A short exercise to create a working URS and a review of the output
Delegates will work on a simple requirements scenario
Output will be discussed with the tutors
The feedback will be combines and fed back to the delegates
Lessons learned will be summarised

Workshop 4: Scalability of Validation
Delegates will be asked to work out what is work a scaled approach to a multi-component system to minimise the cost and time required for validation
How should the system be sub-divided?
How can risk management be applied?
What sub-projects are appropriate?
Who is involved in each??
What will the validation plan look like?

Workshop 5: Application of GAMP® Risk Management Methodology to a Control System (HVAC)
Delegates will work on a case study using risk management to reduce the validation effort.
Setting assessment scales
Assessment of risks
Formulation of an approach
Response to regulatory criticism
Feedback on the outcome of the case study

Workshop 6: Application of GAMP® Risk Management Methodology to a Computer System
Delegates will work on a different case study using risk management to reduce the validation effort.
Assessment of risks
Formulation of an approach
Impact on the validation effort
Feedback on the outcome of the case study

Workshop 7: Design Review
Design Review is a process which ensures that all requirements have been addressed, identifies issues and proposes corrective actions. Delegates will perform a Design Review over extracts from a real life set of requirements and specification documents in order to confirm that all deliverables have been identified and to confirm traceability. There will also be an opportunity to discuss what corrective actions might be required
Review of User Requirements, Functional Specifications and Design Specifications
Completion of a Requirement Traceability Matrix
Reporting of corrective actions
Links to verification activities

Workshop 8: Application of Risk Mitigation and Challenge Testing
An exercise to mitigate risks for given functionality and to determine rigour of testing
Delegates will determine mitigation strategies
Determine the necessary testing
Design test cases
Feedback on the outcome

Interactive Session: Change Control examples
Delegates will work on a variety of change management
Evaluating the magnitude and impact of the change
Application of the principles of risk management
Leveraging supplier and SME (Subject Matter Expert) expertise
Minimising the workload whilst maintaining compliance

Interactive Session: Good Validation Practices
Open session in which delegates score their CSV system themselves s against 12 good validation practices
Each good practice introduced
Delegates score themselves
Results consolidated and fed back
Allows delegates to compare their CSV system against best practice and other practitioners
Minimising the workload whilst maintaining compliance

Case Study – GAMP® 5 approach
A case study will be presented to illustrate how, using the principles in GAMP® 5, the cost of validation was more than halved
The simplification of the validation system
The leverage of supplier expertise
The use of the risk-based approach
The financial and other benefits of the GAMP® 5 approachMinimising the workload whilst maintaining compliance

GAMP® is a trademark of ISPE

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