title: Pharmaceutical Computer Validation Introduction, Manual and CD
author: Daniel Farb
description: Five stars for the series. "of great value to just about anyone who works with prescription drugs." -- <i>Foreword Reviews, December 29, 2004</i>
zlib_text: 50
  Pharmaceutical Technology JANUARY 2003
  www.pharmtech.com
  his article presents a top–down approach to properly im-
  plementing a validation project for electronic spread-
  sheets. The article provides some interesting historical
  background about the evaluation of electronic spread-
  sheets and uses Microsoft Excel as the base spreadsheet appli-
  cation because it is widely used as such. The article discusses
  the shortcomings of electronic spreadsheets and highlights some
  unique solutions and techniques to help pharmaceutical com-
  panies comply with 21 CFR Part 11. The validation approach
  proposed herein is based on the good automated manufactur-
  ing practice (GAMP) methodology but also incorporates specific
  technical test cases and considerations that are unique to the
  qualification of spreadsheets to fully comply with the predicate
  regulations and 21 CFR Part 11.
  Once upon a time in history
  Electronic spreadsheets have been widely used in corporate
  America since their debut in 1978 with