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Saturday, November 26, 2011

Quality Management Systems - Process Validation Guidance




Authoring Group: SG3
Endorsed by: The Global Harmonization Task Force
Taisuke Hojo, GHTF Chair

The document herein was produced by the Global Harmonization Task Force, a voluntary group of representatives from medical device regulatory agencies and the regulated industry.
The document is intended to provide non-binding guidance to regulatory authorities for use in the regulation of medical devices, and has been subject to consultation throughout its development.
There are no restrictions on the reproduction, distribution or use o f this document; however, incorporation of this document, in part or in whole, into any other document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the Global Harmonization Task Force.

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