Frank Behnisch, CSL Behring, Germany
Stefan Münch, Körber Pharma Consulting, Germany
Yves Samson, Kereon, Switzerland
Dr Robert Stephenson, Rob Stephenson Consultancy, UK
As a specialist for the validation of computerised systems, the 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.
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.
Introduction – Gain Understanding of Delegate Experience and Background
Workshop 1: What the Delegates expect
- 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
Workshop 2: 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?
Workshop 3: Scaleability of Validation Activities
- LIMS – Laboratory Information Management System
- Laboratory computerised equipment
- Process control system: PLC – Programmable Logic Controller
Writing Requirements Documents
- Requirements gathering
- Writing good requirements
- Use of templates / boilerplates
- Requirement Quality
Requirements: The Good, the Bad and the Ugly
- Good, bad, and could-be-better requirements
- Testability
- Use of templates / boilerplates
- What you should never write
Ideal Content of a CSV SOP
- Embedding the CSV SOP into the PQS
- Topics to address
Data Integrity and Record Management: A Necessary Long-Term Approach
- Regulatory context
- Document life cycle
- Retention requirements and constraints
- Supporting processes
- Areas of concern
System Classification – A Record-based Approach
- Needs for record-based system classification
- Classification criteria
- Class A, B, C, D
Workshop 4: System Classification
Design Review – How to Apply Critical Thinking?
- CSA – Computer Software Assurance
- Scaleable Risk Management
- Document Review
Workshop 5: Design Review Scaleability
- Combining Risk Management & Design Review
Bringing Legacy Systems into Compliance
- How to approach legacy system remediation
- Examples
- Learning management system
- Laboratory Instruments
Interactive Session: Good Validation Practices
Open session in which delegates score their CSV approach 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
Alternative & Agile Approaches
- Alternative software development models
- Agility objectives
- Need for flexible engineering methodologies
- What Agile engineering is not
- What Agile engineering needs
- Practical approaches and recommendation
Validating Spreadsheets
- Why are spreadsheets high risks?
- Design considerations
- What is important (risk again)!
- How to document spreadsheet validation
Code Review
- Principles of code review
- Regulatory expectations
- Performing code reviews
- How to document code reviews
Elaboration of a Data Integrity Programme
- Data Integrity Programme: What to do?
- Topics to address
- Action planning
- Embedding the Data Integrity Programme into the PQS
- Progress Reporting
Case Studies: Complex Projects
- Global projects
- Roles & Responsibilities
- Data-related requirements
- Large systems
- Phase-based implementation and deployment
- Interface projects
- Roles & Responsibilities
- Testing
Today / Future IT Compliance Challenges
- Open Source Software validation
- Challenge demands Infrastructure platforms for applications
- Global systems validation vs local defence
- Paperless recipes based production – ISA 95 / S 88
- Cloud Computing – Data Integrity
- Validating Artificial Intelligence (AI)
- Challenges for data integrity on Lab-Systems
Real Life Qualification / Validation Projects
- Real Life Qualification / Validation Projects
- Requirements
- Constraints
- Issues identified
- Lessons learned