Journal:Digitalization of calibration data management in the pharmaceutical industry using a multitenant platform
| Full article title | Digitalization of calibration data management in the pharmaceutical industry using a multitenant platform |
|---|---|
| Journal | Applied Sciences |
| Author(s) | Mustapää, Tuukka; Nummiluikki, Juho; Viitala, Raine |
| Author affiliation(s) | Aalto University, Beamex Oy Ab |
| Primary contact | Email: tuukka dot mustapaa at aalto dot fi |
| Editors | Mendyk, Aleksander |
| Year published | 2022 |
| Volume and issue | 12(15) |
| Article # | 7531 |
| DOI | 10.3390/app12157531 |
| ISSN | 2076-3417 |
| Distribution license | Creative Commons Attribution 4.0 International |
| Website | https://www.mdpi.com/2076-3417/12/15/7531 |
| Download | https://www.mdpi.com/2076-3417/12/15/7531/pdf (PDF) |
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This article should be considered a work in progress and incomplete. Consider this article incomplete until this notice is removed. |
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 quality management systems (QMS) commonly rely on measurements for evaluating quality. For this reason, calibration procedures and management of the data related to them are of the utmost importance for quality management in the process industry, made a particularly high priority by 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- and 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 also 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. From testing this POC, 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, platform
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This presentation is faithful to the original, with only a few minor changes to presentation. Grammar was tweaked significantly to improve readability. The PMCID and DOI were also added when they were missing from the original reference.
