How to Audit - Computer Systems
Print
Improving Your Auditing Skills, The How To Audit Series, New for 2012
Wednesday 12 September 2025
York Marriott Hotel, York, UK
£495.00 excl VAT – £594.00 inc VAT
Type: Pharmaceutical
About this course
Computer systems and IT underpin the successful operations of all pharmaceutical and associated companies. They are everywhere in our activities and operations and so the potential audit scope is enormous. However, not all aspects of the systems in use in our regulated environment are GxP-relevant, although some are fundamental to the safety and protection of the patient.
It is important to be able to identify the real risks associated with the use of such systems and focus the attention of the auditor in these areas. This course will approach the auditing of computer systems and the IT Department from that perspective.
Key questions are:
- What is important from the GxP and compliance perspective about computer systems?
- How should I approach the auditing of computer systems?
- What standards are appropriate?
- How do I audit the IT department?
- How do I assess the significance of any findings?
- Is there anything new in the regulatory trends that I need to consider?
This one-day course will attempt to answer all of these questions in a practical way so that delegates have materials they can use in their auditing work.
Course outline
An outline of the course is as follows:
- What should be the focus of audits of computer systems?
- Developing an audit plan for different types of computer systems
- Developing a plan to audit for the IT department and IT operations
- Developing aide-mémoires for these audits
- Classifying audit observations
This course is intended for delegates who have attended the NSF-DBA ‘Effective Pharmaceutical Audits and Self-Inspections’ course, and a good knowledge of the basic principles and practices of auditing is assumed.
Venue
York Marriott Hotel, York, UK
The York Marriott Hotel is within walking distance of York city centre
and its many attractions including the National Railway Museum and
York Minster. Castle Howard, the Yorkshire Dales and the North
Yorkshire Moors are within a 1 hour drive of the hotel. With 151
stylish guest bedrooms the hotel is ideal for the business or social traveller.
The hotel offers a range of banqueting rooms holding up to 190 delegates theatre style, secure WIFI internet access is available in public areas and our recently refurbished Leisure Club features a heated pool, sauna, steam room, Jacuzzi, gymnasium & private tennis court.
The all new Chase Bar & Grill serves a varied menu and offers a wide
choice of refreshments whilst offering unrivalled views of York
Racecourse from its sun terrace. The York Marriott’s recent accolades
include retaining the BDRC Best Conference Venue in Yorkshire
Award for 2008 (for the 3rd year in succession), as well as winning
the highly coveted York Tourism Bureau Award for Hotel of the
Year 2009.
Hotel Accommodation
- We have a block booking of bedrooms at the York Marriott Hotel, at a specially negotiated bed and breakfast rate per delegate per night.
- As part of our improvements to the booking process, we have arranged for an online booking service with the hotel and details of how to make your accommodation booking will be included in your course joining instructions (issued to you at the time of booking). Alternatively you will be able to make a telephone booking directly with the hotel. If you need any help or guidance with the accommodation booking process, please contact our course administration team.
- Your account with the hotel should be settled at check out.
- Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our experts for this course are:
What you've said
“Good aide-mémoires”
Stephen Swan, Merck Sharp & Dohme Ltd
“Fine course”
Martin Slavik, Ferring Leciva AS
An NSF International Company
