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Introduction to Computer Systems Validation

Course Information

This two day course is the ideal external training opportunity for people needing to gain a basic understanding of computerised system validation.  The knowledge gained will help attendees to validate systems within their own organisation for use in GxP (GLP, GCP, GMP, GDP and GPvP) environments, and to audit validated computerised systems to assure compliance with the applicable GxP regulations.

The course starts with an introduction to the regulatory requirements and the system lifecycle and then concentrates on the practicalities of validating computerised systems and auditing these systems.

The course provides a mixture of presentations, discussions and practical workshops.

 

This course will provide delegates with an understanding of the computerised system validation process, including:

  • Definition of end user requirements
  • Risk management, including supplier assessment and techniques for audit planning
  • Validation planning and reporting
  • Linking system development with good business practices
  • Formal testing and qualification
  • Understanding of data integrity and security issues
  • How to assess system validation documentation to verify compliance

Who should attend

  • IT professionals new to implementing computerised systems into regulated environments
  • Quality professionals who monitor or audit computerised systems
  • System owners, end users, tester and project staff

Course Tutors

Tutors will be comprised from the list below:

Nichola Stevens
Director and Principal Consultant, Nuncius Compliance (Course Principal)

Barry McManus
Consultancy Partner, Empowerment Quality Engineering Ltd

Course Material

This course is running in our paper format. Access to the course material will not be given to delegates in advance of the course.

Additional Requirements
(not included in course fees)

Where the venue is Madingley Hall, accommodation and dinner are available for the dates of the course (we recommend you take this as the location has few nearby facilities). If you wish to book alternative dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall.

Course Programme

Please note timings are subject to alteration

 

Day 1 

9.00 Registration 
9.15
Welcome, Introduction and Expectation Setting
 10.00 Why Validate?  Regulations and Guidance on Computerised System Validation
The importance of quality and regulatory requirements and expectations for computerised systems. 
10.45 Break
 11.00 The System Lifecycle and User Requirements
The concept of the system lifecycle and the key outputs from it including definition of user requirements. 
12.00  Exercise 1 - User Requirements
12.45 Lunch 
 13.30 Risk Management
Risk management and its impact of validation. Identification of the deliverables required. 
 14.30 Validation Deliverables
The concept of the validation process and the key outputs from it based upon risk.
 15.30 Break 
 15.45 Supplier Assessment
A discussion on the approaches that might be taken for assessing suppliers and the challenges that might be faced. 
 16.30 Exercise 2 - Supplier Assessment
Planning a supplier assessment with a focus on the key validation deliverables. 
 17.15 Exercise 2 - Feedback and Model Answer 
 17.30 Close of day 
 

 Day 2

 9.00 Test Overview and Test Planning
An overview of the different test phases that might be undertaken and how to plan testing based upon risk.
 10.00 Test Script Design and Execution
How to create a test script and considerations for execution of the testing and review of test results. 
11.00  Break
 11.15 Exercise 3 - Test Script Design 
 12.00 Infrastructure Qualification 
Comparison of qualification with validation.
 12.45 Lunch 
 13.30 Overview of Data Integrity and Security Issues
Integrity, security, contingency and continuity planning. 
 14.15 Maintaining the Validated State
Discussion of processes required to maintain the validated state including backup and restore, access management, incident management/CAPA and disaster recovery. 
 15.30 Break 
 15.45 Change Control
How to manage changes to a validated computerised system. 
 16.30 Exercise 4 - Change Control
Management of changes to infrastructure, software and data. 
 17.15 Course Objectives Summary 
 17.30 Close of course 

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Recommended Products

Booklets

Auditing Computerised Systems
Computerised System Validation
Management of the Training and Competency of Personnel in GxP and Research Environments

Courses

P04 Quality Assurance for Good Laboratory Practice
P08 The Auditing Course
P34 Practical Approach to Auditing Systems and Processes
P41 Advanced Auditing Skills: Audit Planning and Performance
P42 Advanced Auditing Skills: Audit Analysis and Reporting

Webcasts

Webcast - Where Does Audit End?

eLearning Products

Introduction to the Audit Process elearning

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