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- Posts: 193
- Joined: Thu May 11, 2006 11:10 pm
- Location: California, USA
I am just curious if you have a dedicated department to do all the software validation for you (cGMP/GLP). Have you done validation for MS Word, and Excel, or just some validation for spreadsheets/worksheets (to be opened in e.g Open Office) to meet FDA's expectations.
The reason I am asking is because FDA has issued a Warning letter as follows:
(...) there was no software validation. No procedures are established to validate for its intended purpose the Microsoft Word or Microsoft Excel software (....)
(...)off-the-shelf software must be validated for its intended purpose(...)
The url is here: http://www.fda.gov/foi/warning_letters/s6338c.htm
And no COTS (commercial off the shelf) software package is perfect. Even MS Excel 2007 has its share of flaws:
What's 77.1 x 850? Don't ask Excel 2007
The flaw presents itself when multiplying two numbers whose product equals 65,535. Fire up your favorite calculator and multiply 850 by 77.1. Through the magic of zeros and ones, you'll quickly get an answer of 65,535. Those using the Excel 2007, however, will be told the total is 100,000. The program similarly fails when multiplying 11 other sets of numbers, including 5.1*12850, 10.2*6425 and 20.4*3212.5
See the article here: http://www.theregister.co.uk/2007/09/26/excel_2007_bug/
Any thought to remedy the deficiencies and to meet new FDA's expectations would be appreciated.