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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 portional to
the square of the words used to express it. - Al Weisenborn
QSR - GMP Help has been downloaded 2189 times.
 QSR - GMP Help: Trial
Version
Download and Installation Instructions:
Important: If your computer is on a
network you must have administrative rights in order to install this software!
Press the "Download now!"
button. You will be taken to the registration screen and asked to take a moment to let me
know who you are. This information will be held in strictest confidence. You will be given
an opportunity to confirm this information prior to downloading.
QSR - GMP Help Trial Version provides instant access to the following important FDA
documents:
- Medical Devices; Current Good Manufacturing Practice Final Rule; Quality System
Regulation (GMP)
- Guidance for Industry: General Principles of Software Validation
The trial version does not contain the Medical
Device Quality System Manual: A Small Entity Compliance Guide, First Edition
Read about the Compliance
Guide
Key Features
- Search the by topic
- Search the by word or phrase
- Browse topics
- Personal annotation of topics
- Fully indexed
- Bookmarking
- Print
The QSR-GMP 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.
Pricing
The Trial Version is free! It is a fully functional program with no expiration date.
The full version also includes the following FDA Document:
- Medical Device Quality Systems Manual: A Small Entity Compliance Guide.
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