缺乏来自FDA的指南延续了制药企业不愿接受这种新技术。对来自FDA反应的担忧居于企业不情愿接受新技术之首，像如何将验证、审计和Part 11合规的传统概念应用到基于云的模式。然而，已经有许多高度监管行业已经考虑并接受云计算。即使FDA本身也已接受云计算。在2014年FDA Voice的一篇博文中（FDA Leverages Big Data Via Cloud Computing），FDA首席医疗信息官Taha A. Kass-Hout讨论“大数据”和云计算对FDA收集和分析数据能力的影响。但是，当你跟FDA和行业中的个人谈论时，人们仍然认为FDA不允许使用云。
White Paper: Navigating Through the Clouds in Life [PDF]原文地址
White Paper: The Real Cost of Poor Data Integrity in Pharmaceutical Manufacturing [PDF]原文地址
Lachman CONSULTANTS - Linda Evans O'Connor
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Is FDA Starting to Think (Again) About Cloud Computing?
By Linda Evans O'Connor | May 20, 2016
In April 2016, the FDA published its much-anticipated draft Guidance on Data Integrity. This Guidance is a great way for industry and FDA to start and continue the dialogue about data integrity. An interesting note about this Guidance is that buried, deep down on line 142, is a mention of “cloud infrastructure” as a “system” as it relates to “computer or related systems” in § 211.68. Up until this point, the FDA has been largely silent on the use of cloud computing for FDA regulated systems, and industry has taken this silence to be, in many ways, a prohibition to its use.
Does the mention of cloud infrastructure in this document mean that FDA is ready to start thinking about it? Or worse, doing something about it? FDA was reportedly working on a Guidance on cloud computing in 2014, but then it was scrapped, and hasn't appeared on the Guidance Agenda since then.
This lack of guidance from FDA perpetuates the pharmaceutical industries' reluctance to embrace this new technology. Perceived fear of repercussions from FDA is at the forefront of this reluctance, as is how to apply traditional concepts of validation, auditing, and Part 11 compliance to a cloud-based model. However, there are many highly regulated industries that have already figured these out and have embraced the cloud. Even FDA itself has embraced cloud computing. In a 2014 article in FDA Voice, Taha A. Kaas-Hout, FDA's Chief Health Informatics Officer, discusses “big data” and the impact that the cloud has on the ability for FDA to collect and analyze the data. Yet, when you talk to individuals in the FDA and industry, people still believe that FDA doesn’t allow the use of the cloud.
There are some early adopters in the pharmaceutical industry who are “jumping in” with both feet to the cloud. In our experience, these tend to be smaller start-up companies, who either aren't fettered with “old school thinking” (so maybe they don't know better) or don't have the infrastructure to support a non-cloud based solution, so they are figuring out how to make it work.
Certainly, there are some potential data integrity concerns with the use of cloud computing in a regulated environment, but they certainly aren't insurmountable. They are different, but no more so than the concerns that we should have about traditional computerized system models.
Lachman has recently authored two whitepapers, one on cloud computing and the other on data integrity. They can be found on our website (www.lachmanconsultants.com) and are available for downloading here: White Paper: Navigating Through the Clouds in Life [PDF]原文地址 and White Paper: The Real Cost of Poor Data Integrity in Pharmaceutical Manufacturing [PDF]原文地址.
必读岗位及工作建议：
QA（质量保证）：应确保电子记录和电子签名系统符合21 CFR Part 11的要求，包括系统验证、数据保护和审计追踪。
