.: David Anderson Profile and Articles
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1). Validating for 21 CFR Part 11 and Calibration Management SoftwareThe 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.