Live Online Training - Computerised System Validation Master Class

Live Online Training - Computerised System Validation Master Class

Course No 18305


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


As a specialist for the validation of computerised systems, this event will provide you with
  • Suggestions on how current regulatory guidance on computerised systems relating to data integrity, critical thinking and CSA (Computer Software Assurance) can be put into practice
  • Real-life examples of how validation effort can be scaled according to risk-based approaches
  • Answers to specific questions, e.g. on source code review or on creating specification documents
  • The opportunity to bring questions from your own practice up for discussion


The V-model has become a standard worldwide methodology for the validation of computerised systems. Regulatory requirements, as well as industry guidelines, like GAMP®5, are orientated towards this model. In practice, you as a validation specialist will want to know how to apply this model to current and increasingly complex validation projects.

Target Group

The Master Class is directed at employees from
  • IT
  • Production
  • Engineering
  • Quality Assurance
  • Quality Control
Participants should already have gained experience in the validation of computerised systems, and preferably will have also attended a basic CSV Course.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.


Introduction – Gain Understanding of Delegate Experience and Background

Case Study: 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
Current Challenges and Evolution for CSV Activities
  • What does compliance really mean?
  • Data Integrity
  • Securing operation: cybersecurity
  • Project agility
  • Cost efficiency vs effective risk management
  • Applying critical thinking
Roles, Responsibilities and Governance
  • PQS – Pharmaceutical Quality System according to ICH Q10
  • Responsibilities
    • Operational ownerships
    • Supporting roles
  • QA oversight
Case Study: Governance Benchmark
  • Polling Exercise plus facilitated discussion
  • IT and System Governance
  • CSV Roles and Responsibilities
  • Role of Quality Unit
Practical Use of Scalability
  • What do we mean by Scalability?
  • How does it work in practice?
  • How can we combine documents successfully?
  • How much is enough?
Case Studies: Scaleability of Validation Activities
  • LIMS – Laboratory Information Management System
  • Laboratory computerised equipment
  • Process control system: PLC – Programmable
  • Logic Controller
Writing Requirements Documents
  • What goes into a requirements document?
  • What are the considerations for systems?
  • Characteristics of good and bad requirements documents
  • Sources of requirements Information
Requirements: The Good, the Bad and the Ugly
  • ƒGood, bad, and could-be-better requirements
  • ƒTestability
  • ƒUse of templates / boilerplates
  • ƒWhat you should never write
Ideal Content of a CSV SOP
  • ƒEmbedding the CSV SOP into the PQS
  • ƒTopics to address
Data Integrity and Record Management: A Necessary Long-Term Approach
  • ƒRegulatory context
  • ƒDocument life cycle
  • ƒRetention requirements and constraints
  • ƒSupporting processes
  • ƒAreas of concern
System Classification – A Record-based Approach
  • Needs for record-based system classification
  • ƒClassification criteria
  • ƒClass A, B, C, D
Design Review – How to Apply Critical Thinking?
  • ƒCSA – Computer Software Assurance
  • ƒScaleable Risk Management
  • ƒDocument Review
Case Study:Design Review Scaleability
  • Combining Risk Management & Design Review
Bringing Legacy Systems into Compliance
  • ƒHow to approach legacy system remediation
  • ƒExamples
    • Learning management system
    • Laboratory Instruments
Interactive Session: Good Validation Practices
Open session in which delegates score their CSV approach against 12 good validation practices
  • ƒEach good practice introduced
  • ƒDelegates score themselves
  • ƒResults consolidated and fed back
  • ƒAllows delegates to compare their CSV system against best practice and other practitioners
Alternative & Agile Approaches
  • Alternative software development models
    • Unified Process, Scrum
  • Agility objectives
    • Need for flexible engineering methodologies
  • What Agile engineering is not
    • What Agile engineering needs
  • Practical approaches and recommendation
    • Conditions for success
Validating Spreadsheets
  • Why are spreadsheets high risks?
  • Design considerations
  • What is important (risk again)!
  • How to document spreadsheet validation
Case Studies: Complex Projects
  • ƒGlobal projects
    • Roles & Responsibilities
    • Data-related requirements
  • Large systems
    • Phase-based implementation and deployment
  • ƒInterface projects
    • Roles & Responsibilities
    • Testing
Today / Future IT Compliance Challenges
  • ƒOpen Source Software validation
  • ƒChallenge demands Infrastructure platforms for applications
  • ƒGlobal systems validation vs local defence
  • ƒPaperless recipes based production – ISA 95 / S 88
  • ƒCloud Computing – Data Integrity
  • ƒValidating Artificial Intelligence (AI)
  • ƒChallenges for data integrity on Lab-Systems
Elaboration of a Data Integrity Programme
  • Data Integrity Programme: What to do?
  • Topics to address
  • Action planning
  • ƒEmbedding the Data Integrity Programme into the PQS
  • ƒProgress Reporting
Code Review
  • Principles of code review
  • Regulatory expectations of code review
  • Carrying out code reviews
  • Recording and documenting code Reviews
Real Life Qualification / Validation Projects
  • ƒReal Life Qualification / Validation Projects
  • ƒRequirements
  • ƒConstraints
  • ƒIssues identified
  • ƒLessons learned

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