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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

Nichola Stevens
Director and Principal Consultant, Nuncius Compliance (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 Programme

Please note timings are subject to alteration

 

 

Day 1
12.30  Lunch
 13.15  Registration
 13.30  Welcome, Introductions and Course Objectives
 14.15  Regulation and Regulatory Compliance
The importance of quality and regulatory requirements and expectations for computerised systems
 15.00  Break
 15.15  Regulatory Trends and Inspection Readiness
A review of recent regulatory inspection finding and a discussion of effective preparation for inspection
 16.30  The System Life Cycle
The concept of the SLC and the key outputs from it
 17.15  Questions and Answers
Answers to any outstanding questions from Day 1
 17.30  Close of day
 

 Day 2
 09.00  Auditing Computerised Systems - High Level Process
Types, scope, objectives, standards, planning, preparation and reporting of computerised system audits
 09.45  Risk Management
Risk management and its impact on validation.  Identifying the deliverables required.  Then exercise on risk assessment for 3 systems
 10.45  Break
 11.00  Validation Deliverables
The concept of the Validation process and the key outputs from it.  Exercise on validation deliverable based on risk.
 12.00  Project Introduction
The system which will be the object of the project is described and processes and deliverables are explained
 12.30  Lunch
 13.15  Workshop 1 - Vendor Audit
Planning a vendor audit with a focus on the key validation deliverables
 14.00  Workshop 1 Feedback
and model answers
 14.15  Workshop 2 - CSV Audit
CSV Audit - planning your audit then performing the audit of the validation components
 15.00 Break 
 15.15  Workshop 2 - CSV Audit (continued)
 16.15  Workshop 2 Feedback
CSV Audit - feedback
 16.45  Change Control
Change control and ongoing system quality post implementation
 17.30  Questions and Answers
Answers to any outstanding questions from Day 2
 17.45  Close of day
 

Day 3
 09.00  Workshop 3 - Auditing Systems in Operational Use
Auditing Systems in Operational Use (SOPs exercise)
Planning and execution of audits of systems in operational use.  What to look for
 10.15  Break
 10.30  Workshop 3 Feedback
and model answers
 11.00  The Principles of Data Integrity
Integrity, security, intellectual property, contingency and continuity planning
 11.45  Workshop 4 - Audit Trail Review exercise
Current regulatory guidance and best business practice for ensuring continued access to data
 12.30  Lunch
13.15 Workshop 4 Feedback
13.30 Infrastructure Qualification
Comparison of Qualification and Validation
14.00 Different Challenges
New technologies and new concerns for managing them
 14.45  Break
 15.00  Course Objectives Summary and Panel Discussion
A round up of key learning from the course
 15.30  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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