Onsite Calibration from System One

Onsite Calibration

Pharmaceutical Company

Client Challenge
Our client is a worldwide pharmaceutical company located in Pennsylvania. This location is a joint venture of two major companies, specializing in R&D and manufacturing of consumer products. The large manufacturing facility operates 24 hours a day and requires an onsite calibration and repair technician.

The client was challenged by a calibration system that was below federal industry requirements. The onsite technician did not have the necessary training to provide calibrations according to current Good Manufacturing Practices (cGMP). The client’s calibration program lacked the proper training in technical calibration, database management, safety, and cGMPs. Additionally, the facility had insufficient inventory control, making scheduling difficult. The client also recognized that their calibration procedures were inadequate for the types of equipment that were being calibrated. With these challenges, our client did not feel they were getting a proper return on their investment.

Our Solution
Working with their metrology department, System One performed a complete inventory of all equipment and developed a database for tracking equipment calibration. We immediately recruited and trained an onsite technician. With our team leader in place, we re-wrote and implemented a full range of standard operating procedures necessary to perform calibrations to cGMP standards.

Additionally, we worked closely with the client to create a more effective pricing structure. The pricing modifications have assisted them with measuring their return on investment more effectively.

The Results
We have operated a successful calibration program at this consumer products manufacturing site since project inception in January 2000. Our client has been pleased with the results and continues to renew our agreement annually.


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