Validating for 21 CFR Part 11 and Calibration Management Software
The whole process of purchasing a software package, figuring out the auditing logs, purchasing a validation protocol purchasing training on the protocol, hiring help and filling out the 500 1,000 page document for 21 CFR Part 11 compliance is as tedious as it is mind-numbing. On the fun things to do list working on validating software for 21 CFR Part 11 falls somewhere between getting a root canal and walking on broken glass. All that said, as with any other torturous activity, validating software can be made easier and relief can be found given some tips.
Choose the Right Calibration Management Software
If the software being validated has already been purchased then ignore these next paragraphs and move on, otherwise read on.
The task of finding the best fit software for any given company is a whole dissertation in itself. The importance of finding acceptable, robust and stable calibration management software cannot be stressed enough. Too often companies rush into a software choice that will most likely be replaced in a couple years because of new technology or bad...
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