Joining Forces

The German Pharmaceutical Industry Association has implemented a joint pharmacovigilance database, dubbed ‘BPIPheda’, to be used by multiple pharmaceutical firms to manage and electronically transmit case reports of adverse reactions in compliance with EU and international standards. This database, which is hosted on a central server system and accessed via an internet portal, allows each firm an individual secure subsection of the database to store and retrieve its own safety reports. Joined to this database is an ESTRI-gateway – a software program which allows the sending and receiving of safety reports within the EudraVigilance system, with a communication network with the EMEA’s gateway at its centre.

In addition to its core function of sending and receiving case reports, the database system also incorporates many administrative functions, such as queries and the generation of reports (such as Line Listings, CIOMS forms). The database system was validated in compliance with industry standards; however, validation activities were planned and executed using the critical process as a guide, which resulted in a clearer, more concise and more efficient validation documentation.

THE CRITICAL PROCESS

In systems which incorporate many different software components, validation procedures can become very complex. This is especially the case when the individual components are not programmed by the same provider or are to be integrated into a wholly new system. The interfaces between the different components and the individual system requirements of each component render validation activities which are restricted to each component in isolation impractical. Approaching system validation on a component-by-component level would not adequately show the function of the whole system, which is greater than the sum of its parts.