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出自识林

2016-05-26 Lachman CONSULTANTS

2016年4月，FDA发布其万众瞩目的数据可靠性指南草案。该指南对企业和FDA开始和继续关于数据可靠性的对话是很好的方式。关于该指南一条有趣之处被埋藏在第142行，提到“云基础设施”作为“系统”，因为在§ 211.68中其涉及“计算机或相关系统”。直到此时，FDA大部分时间对被FDA监管的系统的云计算的使用保持沉默，企业也在多方面认为这种沉默是禁止其使用云计算。

这这篇指南草案中提到云基础设施是否意味着FDA已经准备开始思考此事了呢？或者更进一步，准备做一些事情呢？据说2014年FDA正在起草关于云计算的指南，但随后被废弃了，从那以后一直没有出现在指南议程中。

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。

制药行业中有一些投入云计算中的早期接受者。根据我们的经验，这些往往是小型创业公司，既不被“陈旧的思想”束缚（所以也许他们不知道更好的）也不具备支持非云解决方案的基础设施，因此他们考虑如何使云发挥作用。

当然，在监管环境中使用云计算也有一些潜在的数据可靠性问题，但这些问题肯定不是不可克服的。问题是不同的，但不会比我们应该对传统计算机花系统模式所关心的问题更多。

Lachman最近写了两份白皮书，一份关于云计算，另一份关于数据可靠性。

• 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In April 2016, the FDA published its much-anticipated draft Guidance on Data Integrity.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.