New Version 9.0 of GMP Navigator Software Released under New Name

GMP News No. 905: New Version 9.0 of GMP Navigator Software Released under New Name

GMP News
14 March 2007
 

New Version 9.0 of GMP Navigator Software Released under New Name

 
At the end of February 2007 the European Compliance Academy released the new version 9.0 of the GMP Navigator CD-ROM under the new name GMP Guideline Manager*.

Similar to the versions of the GMP Navigator before, the unique CD-ROM contains information on current worldwide GMP regulations issued by the most important medicines authorities and organisations worldwide – like FDA, EU, ICH, GHTF, PIC/S. An easy-to-use navigation system allows users to open the "library of guidances".

With the GMP Guideline Manager finding answers is quick and easy. The CD provides comprehensive information on guidelines and regulations containing statements on water for injection, cleaning validation, stability testing – or on any other GMP topic you are interested in. A comfortable search function allows users to browse the several thousand of pages of regulations by key words and to directly retrieve guidelines and guidances they are specifically interested in.

The CD-ROM also holds an archive with the FDA Warning Letters from the past three years, allowing users to search for frequently observed deficiencies. Moreover, in addition to FDA summaries and presentations, industry recommendations have also been added.

The annually updated GMP Guideline Manager cannot be purchased. It is only available free of charge to members of the European Compliance Academy, who receive a copy every time they attend an ECA event. Members can also access the Guideline Manager online version on ECA's website at www.gmp-compliance.org which additionally comprises a "Guideline Tree sorted by topics".

Membership can be acquired automatically through participating in one of the European Compliance Academy courses or conferences (exception: Webinars). In addition, the Academy also offers two other membership opportunities – individual membership and company membership. To find out more, please see the information on the new membership opportunities.

Author:
Oliver Schmidt
on behalf of the European Compliance Academy (ECA)

*The GMP Guideline Manager CD version 9.0 was developed by Concept Heidelberg on behalf of the European Compliance Academy.

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