ISPE issued the second edition of the GAMP® Practice Guide: A Risk-Based Approach to Testing of GxP Systems. This Guide helps the reader to maximize testing efficiency without compromising the quality of GxP Systems by focusing testing on areas that have the greatest impact and eliminating duplicate testing. This GAMP® Good Practice Guide has been recently expanded and updated to conform to GAMP® 5 standards and terminology.
Sie sind ein selbstständiger Berater oder Freelancer im GxP – regulierten Bereich oder haben die Absicht sich selbstständig zu machen? Gemeinsam mit anderen professionellen Mitgliedern in einem renommierten Netzwerk sind verschiedene Vorteile für Sie umsetzbar.
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CCS has published its new Collaborative Consulting Framework Matrix, which defines different options of consulting and delivery solutions.
Please contact us at talk@comes-services.com for more information and details.
The Global Harmonization Task Force (GHTF) website is no longer operational at http://www.ghtf.org/.
The site was moved to the International Medical Device Regulators Forum at http://www.imdrf.org/. The archived documents can be found at: http://www.imdrf.org/ghtf/ghtf-archived-docs.asp
The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization.
It is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and to accelerate international medical device regulatory harmonization and convergence.
Annex 11 (“Computerised Systems”) and Chapter 4 of January 2011 have been revised in response to the increasing use of electronic documents within the GMP environment by the EMA (European Medicines Agency). Two years later (January 2013) we would like to reflect the current status of the implementation at some agencies and the pharmaceutical industry.
Download the article here: Computer System Validation 2013
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