ISPE/DIA Workshop on Computer Systems Compliance

Data integrity surrounding computerised system supported business processes throughout the product life cycle has been at the forefront of recent news, for example Ranbaxy in the USA. The awareness of these issues has changed the approach used by both EU and US regulators in conducting inspections in recent years. As data integrity increasingly becomes a focus of the regulatory authorities, the industry has to recognise and ensure controls for data integrity are implemented and appropriately managed throughout the entire life cycle of the data. Problems with data integrity manifest themselves differently in each phase of the life cycle. Therefore improvements must be managed differently during each phase, based on business risk.

This 2-day conference will provide a forum for information, discussion on conceptual and practical questions and experience exchange through lectures, panel discussions, and interactive workshop sessions. It will focus on the work being conducted by two leading organisations within the life sciences sector who approach the subject from differing directions but with the same clear objective of ensuring data integrity to reduce the risk to the patient. It will focus on the well-established approaches used, identifying the similarities of key principles and practice, and the challenges facing the industry with the availability of new technologies such as cloud computing.