Information Technology, PPD, 2240 Dabney Road, Richmond, VA 23230, USA.
Research & Early Development, Bristol Myers Squibb, Princeton, NJ 08648, USA.
Bioanalysis. 2021 Sep;13(17):1313-1321. doi: 10.4155/bio-2021-0137. Epub 2021 Sep 13.
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.
随着制药行业在需要全球用户随时获取数据和资源的环境中不断发展，药物开发过程中的数据存储面临的挑战变得日益复杂。虽然云服务的效率和相对低成本变得越来越有吸引力，但对云服务的使用犹豫不决的情况有所减少，并且已经发生了向实际应用的重大转变。在 GxP 实验室中，对数据进行云存储的考虑因素包括数据完整性和安全性，以及对全球用户的访问控制和使用。在这篇综述中，讨论了在基于实验室的 GxP 数据存储中使用云存储选项时所面临的挑战和需要考虑的因素，并定义了最佳实践。
