Shocking news on the Internet: http://www.marketwatch.com/story/88-of-spreadsheets-have-errors-2013-04-17
88% of spreadsheets have errors. Assuming this is true, and the pharma, biotech, and med devices are not immune, we could have quite an issue at hand.
Spreadsheets (especially Microsoft Excel) are pervasive in office environments, and there’s no doubt Excel spreadsheets are employed for GMP uses.
One of the principle concerns is the Microsoft Excel is not 21 CFR Part 11 complaint out of the box, in that it does not include an audit trail or electronic signature. Does this mean Excel should not be used for any GMP purpose?
Not necessarily, but you better have a way to control spreadsheets, assure data integrity, and validate calculations in the spreadsheets you do use.
Here’s some great information out there already.
I’ve heard a few times over my career the statement that “Excel cannot be validated.” I think this stems from earlier confusion about validating computer systems in general, and what Part 11 compliance really means. These days however, Excel spreadsheets are validated/qualified, and are used for GMP purposes. If you need to convince yourself of this, search the FDA 483 database for the term “Excel,” and you’ll see that while there are some 483s around use of Excel spreadsheets, the FDA cites the use of “uncontrolled” or “unvalidated/unqualified” spreadsheets. In no 483 is a company cited for the use of Excel for GMP purposes alone. In fact, the FDA’s wording around the use of unvalidated or unqualified spreadsheets implies the agency believes Excel spreadsheets can be controlled, qualified, and using for GMP purposes.