Blog

News

How Compliant Are Your Medical Devices with EU Cloud Computing Regulations?

February 4th, 2015 by

EU Medical Device Cloud Computing RegulationsCloud computing architectures vary widely. In addition to incorporating tons of different device types, they also use diverse routing, layer networking and messaging protocols. These essential variances increase the possibility that security and quality deficiencies could become harder to pin down should they occur. 

In European markets, cloud computing compliance correlates closely with how profitable GxP operations ultimately are. The production, importation and sale of medical devices are all tied to how safely such products fulfill their intended functions.

Although the risks associated with cloud computing and data-aware devices are still evolving, your quality governance methodologies can’t lag behind. A lack of knowledge is no excuse for not keeping up with information security regulations and guidelines.

Why Employ Cloud Computing If It’s so Risky?

The advantages of cloud computing are innumerable, and to a consumer, secure network connectivity may just be what sets your devices apart from a competitor’s. In a life sciences arena populated by technologies like EMR, remote patient monitoring and distributed trial result analysis, cloud technology is almost ubiquitous. 

Cloud computing also affords manufacturers a number of distinct benefits. For instance, some companies build networks around Internet-of-Things (IoT) architectures that incorporate their entire production line. Such tailor made-tools could make it easier to unify QMS records in a single master database. Of course, the fact that these are only support systems doesn’t mean they’re exempt from EU cloud computing validation principles

Do GxP-Regulated Entities Really Need EU-Specific QMS for Cloud Computing?

European product safety rules are unique compared to those from other regions, but most markets share similar methods for devising regulations. Rules never change overnight; regulatory organizations typically follow extended timetables when implementing standards and harmonizing divergent practices

Because cloud computing best practices historically originated with customs popularized by professional organizations, they may bear slight differences. Even if your organization employs a unified QMS architecture like most companies, it’s prudent to incorporate independent quality governance and validation methods for each target market region. 

Where Should EU-Specific Governance Focus?

Although harmonization continues to be a driving force in cloud computing standards development, you still must pay attention to the little details. Successful compliance necessitates a thorough, point-by-point approach. For instance, the software you use to stress test common network vulnerabilities, like Denial-of-service (DoS) attacks, may need to adhere to specific testing parameters. Governance practices that fall short of minimum standards are little more than drains on your organization.

Your compliance system should be just as compliant as you want your cloud-connected products to be. While the regulatory goals laid down in the Europe 2020 framework are still months and years away from full implementation, GxP companies are best off getting their governance practices in place before it becomes a legal necessity.

The certification schemes published by regulatory agencies are some of the best sources of information, but they can be a bit difficult to decipher. GxP-CC consultants teach device manufacturers the language of EU compliance so that they can satisfy their computer system validation and governance obligations. Learn how your organization can master compliance in the cloud by contacting GxP-CC today.

 

About this author:

Avatar

Dr. Hussein has over 15 years of experience in the GMP industry as a successful advisor for top medical device and pharmaceutical companies. In 2008 Dr. Hussein was named as an assessor for project management in the “German Society for Project Management” (GPM). Dr. Hussein holds a Master’s in Physics and a Master’s in Biomedical Engineering from the University of Hannover in Germany. He also holds a PhD in Physics from the University of Luebeck in Germany.

Leave a Reply

Your email address will not be published. Required fields are marked *

*