Data Formats: Trends and Pitfalls

Data Formats: Trends and Pitfalls In the pharmaceutical industry, digitization is becoming the standard, and both data management and data formats play a pivotal role. This presentation highlights com-mon pitfalls in handling data formats and focuses particularly on the challenges result-ing from isolated solutions. Development reports and annual reports as PDFs or in paper format are outdated. Today, not only the availability of current production and analysis data but also data mining and the integration of data from research, development, and production are essential aspects to create a viable design space and make development efficient. Many systems have become established in the pharmaceutical industry, including Quality Management Systems (QMS), Laboratory Information Management Systems (LIMS), Material/Enterprise Resource Planning (ERP/MRP), Electronic Document Management Systems (EDMS), and electronic laboratory notebooks, to name just a few. Added to this are insights from Design of Experiments (DOE) and Multivariate Data Analysis (MVDA). Often, an interface such as a development report is stored as a PDF, which is then read again for the next application using a Python code or an AI application to make is accessible for filtering and analyzing these data pools. Another central theme is the communication between users with expertise and programmers, which often poses a challenge when it comes to translating questions into code. The presentation will propose ways to minimize interface problems and outline steps for integrating various systems to avoid common pitfalls in the implementation and use of modern data formats.