QSR - GMP Help
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The Lord's Prayer is 66 words, the Gettysburg Address is 286 words, and there are 1,322 words in the Declaration of Independence. Yet, government regulations on the sale of cabbage total 26,911 words. - David McIntosh

The Quality System Regulation is 7283 words but certainly more important than cabbage. Sometimes the importance of a concept is inversely proportional to the square of the number of words used to express it. - Al Weisenborn

Screen.gif (1166 bytes) QSR GMP Help

QSR - GMP Help contains the following essential FDA documents:

  • Medical Device Quality System Manual: A Small Entity Compliance Guide
  • Guidance for Industry: General Principles of Software Validation
  • Medical Devices; Current Good Manufacturing Practice Final Rule; Quality System Regulation (GMP) (Read about the Compliance Guide)  

Key Features

  • Search the by topic
  • Search the by word or phrase
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The QSR - GMP Help also provides hypertext links so that you may move instantly from the table of contents to a specific section of the document. The GMP has specific definitions for 28 terms. You may instantly check these definitions by clicking on words or phrases that have a dotted underscore.

Al Weisenborn's QSR - GMP Help was designed for use with the following Microsoft 32-Bit Operating Systems: Windows® 95/98/NT 4.0.

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Last modified: March 15, 2008