Introduction to Computer Systems Validation

Course Information

Join our comprehensive three-day training programme tailored for individuals seeking a foundational grasp of computerised system validation. This course equips participants with essential knowledge to effectively validate systems within their respective organisations for utilisation in GxP (GLP, GCP, GMP, GDP, and GPvP) environments. Attendees will also gain proficiency in auditing validated computerised systems, ensuring compliance with pertinent GxP regulations.

Commencing with an overview of regulatory prerequisites and the system life cycle, the course  transitions into practical aspects, centered around validating computerised systems and conducting subsequent audits.

Engage in a dynamic blend of presentations, interactive discussions, and hands-on practical workshops throughout the course.

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.

Is this course for you?

• 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.

Tutors

Tutors will be comprised of (click the photos for biographies):

Nichola Stevens

Director and Principal Consultant, Nuncius Compliance Solutions Ltd

Barry McManus

Consultancy Partner, Empowerment Quality Engineering Ltd

Programme

Please note timings may be subject to alteration.

Day 1

09:00

Welcome, Introduction and Course Objectives

09:45

Why Validate? Regulations and Guidance on Computerised System Validation

Overview of the regulations and guidance applicable to CSV and their key expectations.

10:30

Break

10:45

The System Lifecycle

The concept of the SLC and the key outputs from it.

12:00

Lunch

12:45

The Validation Process

The approach to validation for different system types and a look at some of the key deliverables.

14:00

Project Introduction

14:15

Exercise 1 - User Requirements

Capturing, agreeing and documenting the user requirements for a system.

15:15

Break

15:30

Exercise 1 - Feedback

16:00

Risk Management

Risk management and its impact on validation. Identifying the deliverables required. Then group discussion on risk assessment for three systems.

17:00

Questions and Answers

Answers to any outstanding questions from Day 1.

17:15

Close of Day

Day 2

09:00

Supplier Assessment

The different approaches to supplier assessment and the things to be considered when assessing a supplier.

10:15

Exercise 2 - Supplier Assessment

Planning a vendor audit with a focus on the key validation deliverables.

11:00

Break

11:15

Exercise 2 - Feedback

11:45

Test Overview and Test Planning

The different test phases, the purpose of each test phase and things to be considered when planning and reporting testing.

12:45

Lunch

13:30

Test Overview and Test Planning

Continued.

14:15

Test Script Design, Execution and Review

What a good test script looks like and the key things to consider when creating, executing and reviewing a test script.

15:30

Break

15:45

Exercise 3 - Creating a Test Script

Create a test script based on user requirements created on Day 1.

17:15

Close of Day

Day 3

09:00

Exercise 3 Feedback

09:30

Infrastructure Configuration and Qualification

10:30

Break

10:45

Validation Reporting

Overview of the Validation Report and what should be included in it.

11:15

Maintaining the Validated State

The procedures and records needed to ensure the system remains fit for purpose.

12:30

Lunch

13:15

Change Control

Key concepts related to making changes to validated systems.

14:00

Data Integrity and Security

How can we assure the integrity and security of our data.

15:15

Break

15:30

Course Objectives Summary and Panel Discussion

A round up of key learning from the course.

17:00

Close of Course