Implementation of a Calibration Wireless System in a Pharmaceutical Facility
Berrios Meléndez, Frances T.
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Abstract - Regulated industries such as Pharmaceutical, Biotechnology and Medical Devices require a Calibration Program, to guarantee the product quality. The objective of this project was to design Calibration Wireless System for the Engineering Department at a Pharmaceutical Facility. In order to achieve the objective of this project, it was required to analyze the data process and follow the Food and Drug Administration (FDA) and General Manufacturing Procedures (cGMP’s) regulation. In order to design the Calibration Output report this is the Calibration Data Record. The Calibration Data Record is a regulatory document with specific requirements. The challenge for this project involves the knowledge of this regulation and adaptation to a wireless system, the decision for the better output device, taking in consideration the kind of work done by these technicians, and utilizing works system criteria. The outcome for this project is the Calibration Data Record, considering all the regulations and guidance. Key Terms - DMAIC, FDA, GUIXT, SAP