Digitalization of Calibration Data Management in Pharmaceutical Industry Using a Multitenant Platform

Abstract

The global quality infrastructure (QI) has been established and is maintained to ensure the safety of products and services for their users. One of the cornerstones of the QI is metrology, i.e., the science of measurement, as the quality management systems commonly rely on measurements for evaluating quality. For this reason, the calibration procedures and the management of the data related to them are of the utmost importance for the quality management in the process industry and given a high priority by the regulatory authorities. To overcome the relatively low level of digitalization in metrology, machine-interpretable data formats such as digital calibration certificates (DCC) are being developed. In this paper, we analyze the current calibration processes in the pharmaceutical industry, and the requirements defined for them in the relevant standards and regulations. For digitalizing the calibration-related data exchange, a multitenant cloud platform-based method is presented. To test and validate the approach, a proof of concept (POC) implementation of the platform is developed with a focus on ease and cost-efficiency of deployment and use while ensuring the preservation of traceability and data integrity. The POC is based on two industrial use cases involving organizations with different roles in the metrology infrastructure. In the testing, the presented approach proves to be an efficient method for organizing the calibration data exchange in industrial use.

Keywords

• digitalization
• quality management
• pharmaceutical industry
• digital calibration certificate
• metrology
• traceability