Computer Validation - The GAMP®5 Approach

Programme

Introduction –What the Participants Expect
An open session capturing the expectations of the delegates

Laws, Regulations and Guidelines for Computer Validation
The historical perspective
Current regulations and regulatory guidelines from US
New regulatory guidance (GAMP® 5, GAMP® Good Practice Guides, ASTM)
New industry guidance
Regulatory training
Harmonisation

Electronic Records and Signatures
What Part 11 means – Now!
Identify e-records in predicate rules
Identify risks to records
Identify appropriate controls for records

The GAMP® 5 Approach to Computer Validation
Validation needs structure
The GAMP® approach
What is new in GAMP® 5
General validation activities
The GAMP® Categorisation System
Life Cycle cost reduction

The EU Annex 11 “Computerised Systems”
What are the important points?
How can you implement it?

User Requirement Specifications (URS)
Why do we need user requirements and specifications?
What should a URS look like – and who should be involved?
How to capture requirements effectively
How does User Requirements documentation go wrong?

Risk Management
Q9 process
GAMP®5 five steps approach
Practical approach to Risk Management: High Level Risk Assessment – HLRA, System Risk Assessment – SRA, Functional Risk Assessment - FRA

Validation Planning
Why is a validation plan important?
Definitions and regulatory expectations
Building risk management into planning phase
Structure and contents of validation plans
Discussion of best approach
The impact of scaleability

Specifications, Design Review and Traceability
What sorts of specifications are needed?
How are they constructed?
Can they be combined?
How to carry out a design review?
How to construct a traceability matrix?

Protocols, Test Scripts and Deviation Management
Principles of Risk-Based Qualification
Leveraging the Supplier
Commissioning vs Qualification
Test Script Design
Deviation Management

Change Control
Regulatory requirements
Configuration management
Responsibilities
Planned/unplanned changes
Classification
Sources of changes

Automation Aspects
System Overview / Specifications
GAMP® and risk analysis
Findings & consequences

Validation Reporting & Presentation to Inspectors
The link between the plan and the report
Key documents
Validation summary reports
Style and emphasis
Managing the inspection

Regulatory Comments
Recent general trends
Highlights from Warning Letters and 483s
Lessons we must learn

Introduction to IT-Infrastructure Qualification
The qualification lifecycle
How to deal with user requirements
Qualification documentation
Critical issues
Qualification summery report

Workshop 1:
Self Evaluation of Compliance with Annex 11

Workshop 2: Evaluation of a User Requirement Specification
A short review of the URS and how to write specifications, as a prelude to a workshop in which delegates will evaluate a real requirements specification.
What is a URS?
Why is it important?
Contents of a URS
Characteristics of good specifications
Testable specifications

Workshop 3: Validation Planning
Based on considerations of the type of application, knowledge of the supplier and how it will be used, delegates will work out the best approach to delivering the benefits of a GxP system
What are the risks associated with delivering the system?
What options do you have to manage the most critical risks?
How can they best be managed?
What are the key issues to monitor to ensure delivery of the project benefits?

Workshop 4: Risk Management in Protocol Planning
Based on a real case study, delegates will use the same risk assessment techniques as in Workshop 2 to determine where to focus the qualification of a packaging line.
Risk management applied to a control system
Using FMEA to assess risks to be managed and
controlled in validation
Identifying options to mitigate (reduce) the higher risks
Using the output in creating the testing protocol

Workshop 5: Managing Deviations
In this workshop examples of deviations will be examined and methods of resolution discussed. The examples are based on real-life protocols.
Test failures found during IQ/OQ
Manage the deviations
Suggest solutions

Workshop 6: Change Control
The participants will work on a number of case studies and define the change control activities needed.
Change Control forms
Approval process
Standard Changes
Committees