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Validated Cloud Computing in Today’s Regulated Environments

October 10th, 2014 by James Francum

FDA Cloud Computing ValidationAdopting cloud-based technologies is a common step for growing firms, but those regulated by the FDA and other organizations must use such tools with caution. While traditional networking software and hardware are extensively covered by countless guidelines, the novel nature of cloud applications and virtual network software means that there's still some confusion about the typical organization's responsibilities.

Although the cloud is a great way to make a firm more efficient, it comes with unique new security and safety concerns. Cloud computing implementations that account for strategic validation planning and techniques are a must for any firm that wants to push forward at the helm of powerful technologies.

Do Regulators Permit Cloud Computing?

Regulatory agencies haven't explicitly barred GxP firms from utilizing cloud computing technologies, and in fact, bodies like the FDA have actively adopted cloud computing. While the agency maintains that its new systems are designed to accept massive data dumps from firms that use varied formats and methodologies, the idea of the FDA being on board with cloud computing is yet in its infancy. 

In all likelihood, practical concerns will limit the agency's ability to accommodate advanced cloud-based compliance information, such as massive, digitized clinical trial results or data pertaining to security standards on scores of networked patient monitoring devices. Firms may have to tweak the way they prove their validation efforts until regulators can catch up.

Is Risk Management Still Relevant?

Cloud-based systems still have numerous inherent risks. Though these differ from those encountered with traditional networking setups, it's still important to adopt a risk-management model. By using identified vulnerabilities, such as access points and third-party technologies, as standards for judging the viability of real-world implementations, those who utilize cloud services validation may be able to create safer operating standards regardless whether official regulatory guidelines are up to speed on the technologies in question. 

Without Official Guidance, How Does a Firm Validate Its Cloud Services?

Don't wait for new, comprehensive compliance standards to bring your distributed computing implementations into alignment with GMP. Although the specifics vary, some of the same strategies, validation lifecycle models and CSV compliance techniques used for traditional software can be applied to improve the robustness, security and ultimate viability of cloud-based systems. In lieu of explicit rules from the FDA or EU bodies, work with consultants who can help you adopt relevant, proven standards, like the recent ISO/IEC 27017 for cloud computing security. 

By putting a validation system into place now, you may very well find it easier to adapt when specific rules change down the line. GxP-CC consultants can help you create a more effective, flexible validated cloud computing implementation for the technologies you rely on most. Learn more by getting in touch today.


Posted in Cloud Computing Applications, Cloud Services Validation, CSV Compliance, FDA & European Regulations, FDA Validation, GxP CC

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James Francum

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