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New Book Examines International IT Regulations and Compliance

LIMS Implementation Addressed When Validating IT Systems

Every now and then the subject comes up about books and what’s available for those who want a bit more of an in-depth look at things than the information offered on the vast but shallow seas of the Internet. There haven’t been many books on LIMS published recently, mainly because the LIMS marketplace has matured and has become a subset of the larger Informatics marketplace as that arena has also matured. This means that looking for publications which examine LIMS issues in-depth has become a bit like looking for the proverbial needle in a haystack. Well, here’s one of those golden needles for your consideration.

Industry guru Siri H. Segalstad (Segalstad Consulting AS, Oslo, Norway), who has been a consultant in the industry since its inception, will be publishing her latest tome this October. Entitled International IT Regulations And Compliance Quality Standards in the Pharmaceutical and Regulated Industries, the book has a rather unusual inception.

While taking part in an EU Leonardo da Vinci project to create a complete curriculum for a Master’s degree in IT Validation, Segalstad spent a considerable amount of time researching issues concerning system implementation and various country regulations. Too much time. She realized there was a need for a comprehensive book that would bring together current thinking on the implementation of standards and regulations in relation to IT for a wide variety of industries.

The result of her research and study is this book, which allows readers to acquire not only knowledge but also understanding of quality thinking, as well as how to apply this knowledge. It allows readers to use the Quality Management System (QMS) as a tool for further development in their organization and to assess QMS from other companies during a supplier audit. In order to understand how to validate different types of laboratory systems, details about such systems are also included.

Segalstad’s book enables readers to understand the process of validation, how to divide validation into manageable pieces, and what is included in the validation for different types of systems.

Topics covered include:

- Quality standards
- Regulatory requirements for IT systems
- Quality Management Systems—QMS
- Organization for an IT system
- Legal implications of an IT system
- Advanced quality management systems
- Validation process and validation techniques
- Validation of IT systems
- Risk assessment and risk management
- Laboratory Information Management Systems (LIMS) and Building Management Systems (BMS)

The comprehensive text will be useful to those working with quality assurance and validation of IT systems and in regulated industries, regardless of which standards they are using.

The book will be available on 17 October 2007 from John Wiley and Sons: http://eu.wiley.com/WileyCDA/WileyTitle/productCd-0470758821.html
Price GBP 70 / € 94.50

The book will also be available from http://www.amazon.com. Price USD 140

More information about the book can be found on Segalstad’s web site at http://www.limsconsultant.com.