Digitalization in the metrology quality infrastructure – perspectives from Novo Nordisk

This paper presents our experiences and challenges with implementing the (DCR) Digital Calibration Request and (DCC) Digital Calibration Certificates initiative in our metrology process at Novo Nordisk, a Danish pharmaceutical company producing medication for chronic diseases. We have a strategic goal to remove all manual transfer of data from our calibration activities, as well as to gain insight by trending on calibration results. Currently, we specify calibration tasks to our suppliers manually, using our IT system, and receive calibration certificates from them mostly as digitally signed PDF-files. We then must manually enter the calibration records into our IT system, which is time-consuming and prone to errors. The DCR/DCC initiative offers a great opportunity to automate both processes companywide, by using standardized and machine-readable formats for exchanging calibration information. Novo Nordisk is actively involved in this initiative, by running pilot projects with several metrology institutes to test the generation and reception of both DCRs and DCCs. However, we have also encountered some data integrity challenges, due to the flexibility of the DCR and DCC schemas. We have realized that, to ensure a robust and reliable transfer process between DCRs, DCCs and our IT system, all these elements must adhere to the ALCOA++ principles, which are a set of criteria for ensuring data quality and traceability in a highly regulated industry.