CAMBRIDGE CONSULTANTS PROVIDES TECAN WITH EUROPEAN & US REGULATORY STRATEGY FOR DIAGNOSTICS SOFTWARE
14 June 2005 - Cambridge Consultants

Cambridge Consultants today announces that it played a pivotal role in bringing the highly advanced Freedom EVOware software from Tecan, a leading player in the life sciences supply industry, to the clinical diagnostics market. The technology based consultancy firm used its expertise in safety-critical software development and heavily regulated markets to advise Tecan Software Competence Centre on a US and European regulatory strategy. This enabled Tecan to move its revolutionary software, which has traditionally excelled in laboratory and research facilities, into the highly competitive world of clinical diagnostics, where Tecan is already a leading supplier of robotic workstations and liquid handling instruments.

Based on a successful family of existing products, such as FACTS and Gemini, Freedom EVOware offers a new intuitive user interface, that simplifies ease of use from basic pipetting to multi-plate scheduled runs, and offers a flexible system for both experts setting up multi-device schedules and beginners with no experience. All of this functionality is available in one package, which has been designed to work across Tecan's complete range of Freedom EVO pipetting instruments in both research and diagnostic applications.

"We have received wide acclaim from many of our clients for the Freedom EVO family of platforms and the Freedom EVOware software that now runs on all of them. Although clinical diagnostics is not a new market to us, we needed to ensure that our radically new software fully complied with the regulations from the ground up, before it was launched. By bringing in an expert like Cambridge Consultants, who has clear expertise in areas such as product audits, safety critical software and compliance methodologies, meant that we had a reliable and independent strategy for moving forward" stated Michael Laab, Managing Director of Tecan Software Competence Centre in Germany.

Duncan Bishop, Programme Director at Cambridge Consultants stated, "Initially used in research facilities the world over, Freedom EVOware became an instant hit as it delivered two important benefits, flexibility and ease of use. By running a thorough audit we were able to identify how the company could prepare Freedom EVOware software for regulatory approval with reduced risk."

The Freedom EVOware software, which was first unveiled in February 2005 at the LabAutomation exhibition in San Jose, California, is an industry first as it guides the user through the program and is capable of managing the most complex pipetting and scheduling tasks. This unmatched functionality opens the door of advanced assay control to a whole new group of users. In addition, Freedom EVOware supports laboratories working under the FDA's 21 CFR Part 11 regulation that need multilevel user management, full audit trail, electronic records and electronic signatures.

http://www.cambridgeconsultants.com/

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