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Cloud Services Validation Creates Safer Operating Standards

April 9th, 2014 by

Cloud Services ValidationAlthough currently seldom used, cloud services are increasingly popular for life sciences firms that want to keep up with their competition. These firms use distributed computing architectures to deliver products more reliably and maintain business information. However, with the restrictions of a GxP-environment coupled with regulatory issues concerning the location of GxP-relevant data/metadata, it means that the rapid proliferation of such technologies isn’t faultless.

Companies that simply expand without addressing security in the process often find that serious vulnerability problems crop up along the way. Cloud services validation is one of the many tools these organizations use to combat such risks and maintain information security standards.

What Makes The Cloud Risky?

IT services require comprehensive security strategies. In addition to having to maintain multiple user access points for structures and applications, such as relational databases and messaging clients, firms that employ networks also need to ensure they transmit and share data safely. The sheer volume of components involved in the operation of a generic network can lead to numerous security risks.

Encryption and other data-handling practices aren’t the only concerns for medical device or pharmaceutical firms. These companies also need to learn to protect their physical installations with appropriate access-control measures and oversight. In addition, staff must be trained to recognize and prevent potential risks that may be beyond the scope of their current professional expertise.

How Does Cloud Services Validation Work?

Validating cloud services is about helping firms and their vendors align their operating standards with some predefined set of security requirements. Because many companies outsource IT technology from third-party vendors, it’s critical to adopt a comprehensive validation strategy that addresses external practices as well as internal usage standards.

Given a set of security standards, validation can help an organization work the guidelines into the agreements that define how related IT services function. Compliance consultants use accepted security practices from industry bodies and regulatory agencies to identify pertinent focus areas, and then they help life sciences companies negotiate service level agreements that address these concerns.

In addition to reducing the risk of actual security-related problems, negotiating proper IT service terms and taking steps to avoid potential issues may help medical device and pharmaceutical firms avoid liability issues later. Companies that rely on distributed supply chains may also find that implementing strict, but fully compliant, IT security validation practices helps them meet the consistent demand for compliance.

Getting Started With Validation

Implementing proper validation practices requires more than good intentions. Most firms need to make thorough, impartial evaluations of their current operating methodologies before they even know where to begin applying corrective measures. Some cooperate with experts who may have various levels of cyber security accreditation in order to realize effective changes.

The potential scope of cloud-based security risks is extremely broad; organizations that rely on their own limited knowledge and resources are likely to miss vital factors along the way. It’s also critical to maintain GxP cyber security validation practices after their initial implementation.

Firms that want to keep their products marketable take the steps required to qualify the components and validate the applications that drive development and production, and cloud services are no exception.

GxP-CC is comprised of a leading group of compliance experts in the life science industry frequently called on by medical device, pharmaceutical and dental lab companies to assist them with a customized GxP compliance strategy. Contact them today to discuss your compliance needs.

 

 

About this author:

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.

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