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)
Accommodation is available at Madingley Hall for the dates of the course. 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 |
Recommended Products
Booklets
Auditing Computerised Systems Booklet
Computerised System Validation Booklet
Management of the Training and Competency of Personnel in GxP and Research Environments
Courses
P04 Research 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
P46 Fraud and Misconduct: Detection, Investigation and Management
Webcasts
Webcast - Where Does Audit End?
