Valid Statistical Techniques SOP
on which to base your company's procedure
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copyrighted by John Zorich.
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This Standard Operating Procedure (SOP) is based upon the author's statistical consulting experience since 1999, during which time he also performed more than 500 quality-system audits at more than 200
bio-tech companies. He believes that something like this helps meet FDA and ISO requirements related to "procedures" for "valid" and "appropriate" statistical techniques, especially in regards to risk management.
Version
Date
Changes
1.03
2017-08-31
--Added note about Word_2011 issue
1.02
2017-08-17
--Added instructions for copy/paste
--Added note about WORD_2010 issue
1.01
2017-08-16
--First version released for distribution
Feedback from Users
Send feedback to     JOHNZORICH@YAHOO.COM
Compliments
Issues
2017-08-31
  • VP Quality/Regulatory: "Super paper -- will have to read it
    very carefully to gain even a few of the nuggets available."

2017-08-16
  • Director of RA/QA : "Thanks for sending this, John. It's
    very helpful."
  • Senior Quality Engineer: "Wow. Thank you John for
    sharing your wealth."
  • Risk-Management Consultant: "Looks really
    comprehensive, John."
2017-08-17
  • One user reports that when viewed with MSWord_2010, a few
    text-boxes look out-of-place, but that after copying the entire
    document to a blank copy of Word, the text-boxes can be easily
    moved out of the way of each other. (Same issue reported on
    Aug 31, regarding MSWord_2011).