Course No 16069
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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
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
Performing a Supplier Assessment
Why Assess the Supplier?
The Overall Process
Types of Assessment
Corrective Actions & Follow Up Audits
Identifying Leveraging Opportunities 1: Quality Planning
Identifying Leveraging Opportunities 2: Leveraging Testing Activities
What must the supplier do
What must the regulated company do
Which supplier tests can be accepted
Managing Quality within an Outsourced IS/IT Environment
Making a Business Case
Outsourced Supplier Specification and Selection
Contract Change and Exit
Computer Systems Validation Master Class
Introduction – Gain Understanding of Delegate
Experience and Background
Roles, Responsibilities and Governance
Activities for Effective Governance
Process and System Ownership
The role of Subject Matter Experts
The role of QA
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
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?
Making Use of Risk Information
Generation a process risk register
Using the risk register to:
Identify the range of risk-based controls necessary for the effective management of the process
Identify critical tests for qualification or verification
Help manage change, incidents, the focus for audits etc.
Identify the residual risks to be managed
Show embedding of risk management within the
Quality Management System
Design Review – A Critical Process
When to perform a Design Review?
Who should participate?
How to document the Review
How to manage the findings
Upcoming Challenges in IT
Open source software
Paperless Production: EBR with Vertical Integration
Cloud Computing / Virtualisation
Infrastructure Qualification / ITIL
Interactive Session: Good Validation Practices
Open session in which delegates score their CSV system themselves 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
Change Control and Configuration Management
Interactive Session: Change Control Examples
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
Why are spreadsheets high risks?
What is important (risk again)!
How to document spreadsheet validation
Risk Management and Electronic Records
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
Principles of code review
Regulatory expectations of code review
Carrying out code reviews
Recording and documenting code reviews
Data Integrity – Formulating a Company Strategy
Incorporation of data governance in the Quality
Defining appropriate metrics
Auditing the data integrity processes
Handover – the Process and Package
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?