Assuring Data Integrity and Data Privacy Compliance when using Software-as-a-Service (SaaS) in the Life Science Sector

摘要

Data integrity (DI) and data privacy (DP) challenges have received increased regulatory attention in recent years. When considering GxP applications, a robust approach to risk-based computerized system lifecycle management requires well-defined processes, use of a qualified infrastructure, validated design and deployment of software, qualified personnel, rigorous change management and version control. With the increased adoption of cloud-based applications in the life science sector, cloud computing solutions such as Software as a Service (SaaS), offer many advantages including enhanced cost-effectiveness, ease of implementation, and flexible, highly scalable platforms. However, assuring data integrity and data privacy in the cloud requires a well-informed, proactive approach by the regulated organization in planning and maintaining control of their data once it is hosted on the cloud provider’s site. This paper aims to examine the current regulatory expectations from the prospective of both data integrity and data privacy and proposes that when it comes to cloud computing, the most powerful tool organizations possess to assure data quality and security lies with their third party supplier contracts.