How to Audit - Computer Systems
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Improving Your Auditing Skills, The How To Audit Series
Wednesday 20 to Thursday 21 February 2026
York Marriott Hotel, York, UK
£1400.00 excl VAT – £1680.00 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 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. With 151 stylish guest bedrooms the hotel is ideal for the business or social traveller.
Secure WIFI internet access is available in public areas and their recently refurbished Leisure Club features a heated pool, sauna, steam room, jacuzzi, gymnasium and private tennis court.
Hotel Accommodation
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Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
- To take advantage of this offer, you must book via a special weblink, details of which will be provided to you on receipt of a completed booking form.
- This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
- 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
