Our client is a multinational Fortune 500 pharmaceutical company aiming to provide best-quality products and services to the customers, along with high responsibility standards to the patients and consumers.
The customer has multiple sites with their own approaches (mostly document-based) to managing processes of production, data capturing and visualization. This makes cross-site data analysis, root cause analysis and criticality analysis troublesome. The customer needs a common knowledge management strategy for optimizing physical workflows of materials.
The Recipe Framework (S88/S95 standards) is used to achieve the goal. We developed the Integrated data management (IDM) platform for process data and analytical data with the initial focus on few company sites' production. After the analysis of the existing data, we designed two Oracle databases. The first one is a transactional DB that serves as a global repository for recipe definition and acts as the source for population of the other database. The second database is an IDM data warehouse designed for fast search of recipes, results, reference data and other high-level information. We designed an ETL solution which extracts data from various source systems used in planning and manufacturing of the products and populates the relevant database entities.
We also developed a web-based Silverlight application, IDM Portal, to be used by the end users for authoring recipes, managing reference data, and viewing reports. Telerik UI for Silverlight was used at the client side to enable rich features of the desktop applications in the browser-based application. At the server side, WCF RIA Services and Entity Framework allow the complex business logic of the application, along with network fault tolerance and concurrent data update issues handling. A rich set of features allows users to manage data conforming to S88/S95 standards in a user-friendly and easy-to-use environment.
The IDM Analytics Dashboard plugin for the internal company’s data mining tool provides multiple options to query, analyze and visualize the data from IDM data warehouse. It is a set of desktop applications developed using .NET platform and WPF Framework.
IDM is a US Federal Drug Administration validated application. It is developed according to GxP guidelines by a distributed customer project team running other system parts, such as ETL and Data Reporting, using Agile methodologies.
IDM development allowed the customer to significantly increase the manufacturing knowledge, providing the possibility to proactively identify potential deviations in Product Quality attributes and rapidly respond to investigations. Using the recipe-based approach, the customer now has easy access to products process information with batch context. The developed platform and approach for integrated data management allows leveraging process, knowledge, and tools thereof, across company’s product portfolio.