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Auditing Computerised Systems

Course Information

This two and a half day course offers the ideal external training opportunity for auditors, those who manage audit programmes and those who will be audited, to develop the understanding and skills necessary for auditing the validation of computer systems intended for use in GxP (GLP, GCP, GMP, GDP, GPvP) environments.

The course starts with an introduction to the regulatory requirements and the system life cycle and then concentrates on the practicalities of computer system validation audit.

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

Delegates will benefit from practical examples of how to

  • understand the framework of applicable regulations and guidance
  • apply risk management techniques to audit planning
  • plan and conduct computerised system audits
  • assess system validation documentation to verify compliance
  • evaluate data integrity and security issues
  • prepare for regulatory inspection

The course is structured to encourage delegates to

  • discuss and develop ideas
  • solve specific problems
  • understand the vulnerabilities of computerised systems
  • learn how to create a compliance checklist
  • link system development with good business practice

Course Tutors

Thanabalan Subramanian
Head of Computerised Systems Validation Strategy, Otsuka Europe Development & Commercialisation Ltd (Course Principal)

Keith Thornley
Regional CSQA Representative, Eli Lilly & Co Ltd

Recent Feedback

"Both [tutors] were very friendly and helpful and between them had a lot of knowledge on systems."

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

Day 1

12.30 Lunch
13.15 Registration
13.30 Welcome, Introduction and Course Objectives
13.45 Regulation and Regulatory Compliance
The importance of quality and regulatory requirements and expectations for computerised systems
14.30 A Risk-based Audit Programme
The risk management process for developing a computing audit programme for an organisation
15.15 Break
15.30 The System Life Cycle
The concept of the system life cycle and the key outputs from it
16.15 Auditing Computerised Systems - High Level Process
Types, scope, objectives, standards, planning, preparation and reporting of computerised system audits
17.00 Questions and Answers
Answers to any outstanding questions from Day 1.
17.15 Close of day

Day 2

9.00 Risk Management
Risk management and its impact on validation. Identifying the deliverables required. An exercise on risk assessment for three systems
10.00 Validation Deliverables
The concept of the validation process and the key outputs from it. An exercise on validation deliverables based on risk
10.45 Break
11.00 Project Introduction
The system which will be the object of the project is described and processes and deliverables are explained
11.15 Project 1 – Vendor Audit
Planning a vendor audit with a focus on the key validation deliverables
12.15 Project 1 Feedback and model answer
12.30 Lunch
13.15 Project 2 – Computer System Validation Audit
Audit of validation components
15.00 Break
15.15 Project 2 Feedback
16.00 Change Control
Change control and ongoing system quality post implementation
16.45 Questions and Answers
Answers to any outstanding questions from Day 2
17.00 Close of day

Day 3

9.00 Principles of Data Integrity
Integrity, security, intellectual property, contingency and continuity planning
9.45 Project 3 - Auditing Systems in Operational Use
Planning and execution of audits on systems in operational use. What to look for
10.15 Break
10.30 Project 3 continued
11.00 Project 3 Feedback and model answer
11.45 Continuing Access to Data
Current regulatory guidance and best business practice for ensuring continuing access to data
12.30 Lunch
13.15 Infrastructure Qualification
Comparison of qualification with validation.
13.45 Regulatory Trends and Inspection Readiness
A review of recent regulatory inspection findings and a discussion of effective preparation for inspection
14.30 Break
14.45 New Challenges
New technologies and new concerns for managing them
15.00 Course Objectives Summary and Panel Session
A round up of the key learning points from the course and a final opportunity for delegates to get answers to their questions
15.30 Close of Course

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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

C8012 Auditing Computerised Systems (16th Apr 2018 - 18th Apr 2018 )
C8022 GCP Auditing - Principles and Practice (11th Sep 2017 - 13th Sep 2017 )
C8023 GCP Auditing - Principles and Practice (26th Feb 2018 - 28th Feb 2018 )
C8041 Research Quality Assurance for GLP (26th Sep 2017 - 27th Sep 2017 )
C8042 Research Quality Assurance for GLP (10th Apr 2018 - 11th Apr 2018 )
C8082 The Auditing Course (30th Oct 2017 - 31st Oct 2017 )
C8083 The Auditing Course (6th Feb 2018 - 7th Feb 2018 )
C8371 Computerised System Validation (19th Mar 2018 - 21st Mar 2018 )
C8421 Advanced Auditing Skills: Audit Analysis and Reporting (6th Sep 2017 - 7th Sep 2017 )
C8422 Advanced Auditing Skills: Audit Analysis and Reporting (21st Feb 2018 - 22nd Feb 2018 )

Webcasts

Webcast - Where Does Audit End?

eLearning Products

Introduction to Risk Based Quality Systems (RBQS) elearning
Introduction to the Audit Process elearning

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