Cloud Solutions for GxP Laboratories: Considerations for Data Storage

Abstract

Challenges for data storage during drug development have become increasingly complex as the pharmaceutical industry expands in an environment that requires on-demand availability of data and resources for users across the globe. While the efficiency and relative low cost of cloud services have become increasingly attractive, hesitancy toward the use of cloud services has decreased and there has been a significant shift toward real-world implementation. Within GxP laboratories, the considerations for cloud storage of data include data integrity and security, as well as access control and usage for users around the globe. In this review, challenges and considerations when using cloud storage options for the storage of laboratory-based GxP data are discussed and best practices are defined.

Achieving Digital Catalysis: Strategies for Data Acquisition, Storage and Use

“…However, this should ultimately be possible as SOPs are well established for other disciplines-in particular in the biosciences [86] -and actively applied and discussed amidst Good Practices (GxP), also as part of codes of conduct. [87] Concepts such as data integrity and storage, [88] or recommendations on how to write SOPs, [89] have already been discussed in these fields and can be directly applied to other subjects. As experiments following SOPs can be demanding for a researcher, a major challenge of this approach is how to manage the motivation of the scientists involved and enhance creative work.…”