## 1 Introduction
For this reason, ensuring the trustworthiness of the process instruments is an essential part of quality management in the pharmaceutical industry, which is why the measurement systems and their maintenance and calibration procedures are highly regulated [9; 10; 11]. Ensuring the data integrity of the measurements and any calibration-related data in particular is of the utmost importance for this purpose, which is why detailed records and audit trails for the processes are required [12]. Consequently, any processes including human operations, e.g., related to the documentation and handling of calibration data, will typically require several inspection and approval procedures to prevent the occurrence of human errors. Since harmonization of the data formats is essential for the interoperability and overall efficiency of digital systems, important areas requiring in-depth examination are the established standards, regulations, and guidelines that provide the framework for the current data formats and processes. Thus, a key question for the success of the digitalization efforts becomes how compatible and applicable are the requirements defined for the different parties in QI in a fully digital environment. In general, the success of industry-wide transition in the digital environment relies on organizational capabilities to adapt to and uptake new technologies and systems when necessary. Thus, an important aspect of the digital transformation is ensuring the ease of adaptation, inexpensiveness, and sufficient scalability of the processes and systems so that the requirements of various types and sizes of organizations can be fulfilled. One possible solution for arranging these kinds of systems and services in a scalable manner is the utilization of a common cloud platform. An example of such a concept in the domain of metrology is the European Metrology Cloud project, aiming to advance the digitalization of legal metrology in Europe [7; 13]. Optimal digitalization of the calibration data management requires a thorough understanding of the underlying processes and workflows. In this paper, we investigate the current practices and general requirements for calibration data management as a part of the quality management in the pharmaceutical industry. We analyze the significance and feasibility of the requirements for the harmonization of digital processes. The paper presents ways to optimize calibration data management processes, allowing improved efficiency by reduced manual work and removing the possibility of human errors in calibration data management. Thus, the traceability and data integrity can be preserved between the organizations in the calibration chains. Furthermore, the proposed approach enables data analysis of the calibration data in a completely different scale compared to the printed A4/paper on glass (e.g., PDF) approach. A proof of concept (POC) of the method was developed by prioritizing the ease of adaptation to the digital processes. Thus, the implementation utilized systems already widely used in the industry, e.g., for user and access management. Thus, the set-up and operation of the platform required a less complex infrastructure compared to a fully proprietary infrastructure, as used in [13,14]. To summarize, we present the following contributions beyond the state-of-the-art:  
1. Investigation of calibration procedures in the digital calibration certificate (DCC) [15] context, including the core standards and regulations in the case of the pharmaceutical industry;
2. Analysis of the applicability of the standards and regulations for the implementation of machine-proof data formats and application programming interfaces (APIs), acknowledging that the existing procedures, standards, and regulations have been prepared for human interpretation;
3. Optimized digital data management processes for preserving traceability and data integrity in calibration chains;
4. A concept for a multitenant platform for establishing ecosystems for collaborating organizations within the metrology infrastructure;
5.