May 2005
Are Your Computerised Systems 'Fit for Purpose?'
So... you know all about ICH GCP, you attended a presentation on 21 CFR Part 11, you've been briefed on the contents of recently released regulatory authority guidelines, and you have read Computer Systems Validation in Clinical Research – a practical guide, version 1 and/or version 2 – now what?
Are you more confused than when you started? What does 'fit for purpose' actually mean? How do you take a 'risk based approach' to system validation? How much documentation is REALLY necessary? What does an auditor or inspector expect to find when they audit a clinical computerised system? Help is at hand, help to take all that theory and jargon and convert it into a practical plan that you can fit around your day job and still deliver the business benefits of a quality computer system that does what the users need AND complies with FDA and other regulatory requirements.
The Clinical Research Computer System Validation Working Party, sponsored by ACDM and PSI, who recently published version 2 of their practical guide have also now updated the workshop they present in conjunction with the ACDM Training Committee. The workshop was originally developed, at the request of the ACDM, after publication of version 1 of the guideline and has been presented about twice a year ever since. The course has always been very well received by those attending, with feedback including comments such as 'The most useful aspect of this course was the ability of the instructors to relate the material to our daily activities' and 'Experienced presenters, many real-world examples and good exercises'.
When version 2 of the guideline was published the working party members launched into a re-write of the training to reflect the most recent thinking included in the new version. In order to make the course more accessible to those who need the information the course has been re-structured to allow a half-day Fundamentals of Implementing Computerised Systems in Clinical Research course, which will serve as an overview of basic principles of the implementation of quality systems. Systems which will then, of course, comply with the necessary regulatory requirements. The bulk of the material now takes the form of an enhanced 2 day course – 'Implementing Computerised Systems in Clinical Research – an advanced course'. This course, in conjunction with the guideline, will ensure that those attending will leave equipped with real-world hands on skills to implement computerised systems, of any size or complexity, with the assurance that they will be validated, and comply with the necessary regulations.
The fundamentals course is not a pre-requisite for the advanced course, it is useful preparation, but attendance is not essential for understanding of the material for the 2 day course. The sessions in the first couple of hours on Day 1 will ensure that whatever previous understanding of CSV delegates may have, they all get onto the 'same page', and can all benefit from the numerous presentations, discussions and interactive workshop sessions. The Implementing Computerised Systems in Clinical Research – an advanced course, will next be presented by ACDM on 22/23rd June, see the website or your recent mailing for details.
If necessary, this course can also be presented in-house for companies with more than 10 staff needing to attend, please contact Heather Wells or Andrew Gold for details.
Jane Tucker
CRSCV Working Party