Our client is a multinational Fortune 500 pharmaceutical company aimed to provide products and services of the best quality to the customers along with high responsibility standards to the patients and to all who use its products.
The Customer has multiple sites with their own approaches (mostly document-based) for managing processes of raw material to final product transformation, 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. Integrated Data Management platform was developed for process and analytical data with initial focus on few company sites production. After existing data analysis, two Oracle databases were designed. The first one is a transactional DB that serves as global repository for recipe definition and acts as the source for the other database population. The second database is an IDM data warehouse designed for fast search of recipes, results, reference and other high level information. ETL solution has been designed which extracts data from various source systems used in planning and manufacturing of the products and populates the relevant database entities.
The web based Silverlight application IDM Portal developed to be used by the end users for authoring recipes, managing reference data and viewing reports. Telerik UI for Silverlight is used at the client side to provide rich features of desktop applications to browser based application. WCF RIA Services and Entity Framework at the server side allow the application to have complex business logic along with network fault tolerance and concurrent data update issues handling. The rich set of application features allows users to manage data conforming to S88/S95 standards in a friendly and easy to use environment.
The IDM Analytics Dashboard plugin for the internal company’s data mining tool provides wide abilities 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 being developed with GxP guidelines with distributed customer project team running other system parts such as ETL and Data Reporting using Agile methodologies.
IDM development allowed customer to increase significantly products manufacturing knowledge, providing the ability 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. Developed platform and approach for Integrated Data Management provides the ability to leverage process, knowledge, and tools thereof, across complete company’s product portfolio