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Auditing Computerised Systems

If you are wanting to book more than one person onto a course(s) please email courses@therqa.com

For Madingley Hall courses, if you wish to stay for additional nights or double occupancy, please contact the us - courses@therqa.com in the first instance

Course Information

This three 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

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

Barry McManus
Consultancy Partner, Empowerment Quality Engineering Ltd

Recent Feedback

"Both [tutors] were very friendly and helpful and between them had a lot of knowledge on systems."
"Wow, Nichola was an absolutely superb trainer. She was a fountain of knowledge, and clearly an expert in her field. I appreciated how approachable she was too."

Course Programme 

Please note timings are subject to alteration



Day 1

09:00  Welcome and Introductions
 09:45  Why We Validate and Regulatory Trends
 10:30  Break
 10:45  Audit Overview, High Level Process and Scheduling
11:30  System Lifecycle
12:30  Lunch
13:15  Exercise 1 - Audit Scheduling
14:45  Exercise 1 - feedback
15:15  Break
15:30  Validation Deliverables
 16:30  Risk Assessments
 17:30  Close of Day 1

 Day 2

 09.00  Supplier Assessment
 10:30  Break
 10.45  Exercise 2 - Planning a Supplier Audit
 12:00  Exercise 2 - feedback
 12.30  Lunch
 13.15  Exercise 3 - Auditing a Computerised System Validation Package
15:30  Break
 15.45  Exercise 3 - feedback
 16.30  Change Control
 17.15  Close of Day 2

Day 3

 09.00  Infrastructure Qualification
 09:45  Maintaining a Validated State - Operational Processes
 11.00  Break
 11.15  Exercise 4 - Auditing Systems in Operational Use 
 12.45  Lunch
 13.30  Exercise 4 - feedback
 14:15  Exercise 5 - Auditing Trail Review
 15:30  Break
 15.45  Exercise 5 - feedback
 16:15  Course Objectives Summary and Any Additional Questions
 16:45  Close of Course

Course Material

Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this course. 

The advantages of this include

  • Ability for delegates to keep material on a mobile device
  • Ability to review material at any time pre and post course
  • Environmental benefits – less paper being used per course

The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.

You will also receive a copy of our booklet - "Auditing Computerised Systems"

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 additional dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall. Bed and Breakfast is £77*, dinner (three courses with drinks, in the main dining room with other course participants) is £35* (* per night per person) - these can be selected during the booking process.  As part of the booking process we ask for dietary requirements and these will be taken in to consideration by Madingley Hall.  Alternatively bar snacks are available on a pay as you go basis, not bookable through RQA.

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