Implementing a Calibration Management Software System in a Regulated Environment

by Walter Nowocin

Implementing a Calibration Management Software System is a critical process for a calibration laboratory, especially in a bio-medical regulated environment. However, there are few examples or documents that explain this process from a user’s perspective. The objective of this paper is to explain the implementation process, provide examples of the documentation used, and to pass along lessons that were learned. The following topics will be discussed: Implementation Process Overview, System Development and Validation Life Cycle, Data Conversion, Test Scripts, Training, and Project Planning.

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