Frank Behnisch, CSL Behring, Germany
Maik Guttzeit, GEA Lyophil, Germany
Yves Samson, Kereon AG, Basel, Switzerland
Dr Rob Stephenson, Rob Stephenson Consultancy, UK
Computer Validation: Leveraging Suppliers
Introduction – What the Participants Expect
An open session capturing the expectations of the delegates
Leveraging Suppliers Expertise: An Overview of Good Practice
Performing a Supplier Assessment
- What is current Good Practice?
- Optimising Supplier involvement
- Integrating the Supplier’s expertise and deliverables into your validation process
- How to do more with less
Identifying Leveraging Opportunities 1: Quality Planning
- Why Assess the Supplier?
- The Overall Process
- Assessment Topics
- Types of Assessment
- Corrective Actions & Follow Up Audits
Identifying Leveraging Opportunities 2: Leveraging Testing Activities
- Quality Planning
- Assuring Quality
- Quality Controls
Managing Quality within an Outsourced IS/IT Environment
- What must the supplier do
- What must the regulated company do
- Which supplier tests can be accepted
Computer Systems Validation Master Class
Introduction – Gain Understanding of Delegate Experience and Background
Roles, Responsibilities and Governance
- Making a Business Case
- Outsourced Supplier Specification and Selection
- Contract Change and Exit
Writing Requirements Documents
- Activities for Effective Governance
- Process and System Ownership
- The role of Subject Matter Experts
- The role of QA
Practical Use of Scalability
- What goes into a requirements document?
- What are the considerations for systems?
- Characteristics of good and bad requirements documents
- Sources of requirements information
More about Risk Management
- What do we mean by Scalability?
- How does it work in practice?
- How can we combine documents successfully?
- How much is enough?
Design Review – A Critical Process
- 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
- When to perform a Design Review?
- Who should participate?
- How to document the Review
- How to manage the findings
Interactive Session: Good Validation Practices
- Open source software / Agil
- Global systems
- EBR / MES
- Cloud Computing / Virtualisation
- Infrastructure Qualification / ITIL
Open session in which delegates score their CSV system themselves against 12 good validation practices
Change Control and Configuration Management
- 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
Interactive Session: Change Control Examples
- Planned/unplanned changes
- Delegates will work on a variety of change management scenarios
- 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
Risk Management and Electronic Records
- Why are spreadsheets high risks?
- Design considerations
- What is important (risk again)!
- How to document spreadsheet validation
- 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
Data Integrity – Formulating a Company Strategy
- Principles of code review
- Regulatory expectations of code review
- Carrying out code reviews
- Recording and documenting code reviews
Handover – the Process and Package
- Management accountability
- Incorporation of data governance in the Quality Management System
- Defining appropriate metrics
- Auditing the data integrity processes
- Reviewing progress
- 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 subdivided?
- 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 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 6: Design Review
The delegates will be presented with the typical findings from a Design Review and, in a team-based exercise, will develop a set of risk-based corrective actions to address the issues.
Workshop 7: Data Integrity
The delegates will be presented with an audit observation about deficiencies in the management of data. They will be asked to device a programme to improve data integrity governance as part of the response to the regulatory observation.
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 approach