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The FDA’s 21 CFR Part 11 has hit the Pharmaceutical Industry like a firestorm. Most Pharmaceutical companies understand that process data needs to be saved and stored in new way, but they are unsure to what process data 21 CFR Part 11 pertains and how to store it. This paper will describe the recent history of process data collection. Some specific terms will then be defined. The process data itself will be described and implementation issues and validation strategies will be discussed.
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