Validation of Computerized Systems in a Global GCP Cloud: What can manufacturing and the GMPs learn?

What primary industry problem or opportunity does your topic address? In order to conduct a clinical trial, a number of key computerized systems are essential. Today these systems are often hosted and/or maintained in part or full outside the technical remit of the data owner(s). In addition, a level of frequent integration requires data exchange across and amongst systems. This poses a unique challenge for the sponsor company. The sponsor is required to maintain assurance that data is controlled at any given point in time irrespective of whether the data is within their technical and/or physical environment. This situation has become even more pronounced following issued guidance on electronic source documents/data in clinical investigations. Therefore, there is a heightened need to consider computerized systems validation, including security aspects, in the overall context of multiple integrated systems across Software as a Service (SaaS) and Cloud providers. In order to conduct a clinical trial, a number of key computerized systems are essential. These systems are often hosted and maintained through Cloud and/or SaaS providers. Critical aspects of computerized systems validation and security within the Cloud shall be considered and discussed as part of this session, as well as the current framework of the clinical environment.