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White Paper: Computer System Validation And FDA Inspections

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Description

By Michael Gregor

Often, the FDA comes to inspect your facility for reasons other than your computer system validation (CSV) program. However, because so many of our business processes are governed by electronic systems, the topic of CSV inevitably comes up during the course of an inspection. Because of an increase in the number of federal investigators, they are able to inspect more facilities and dig deeper into areas such as CSV.

Used with permission from Life Science Leader magazine.

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