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IT Infrastructure Qualification: Keeping GxP Firms Tech-Compliant

March 26th, 2014 by

IT InfrastructureMedical device manufacturers and pharmaceutical companies use advanced IT tools to maintain sensitive business information, manufacture products and establish valid Quality Systems. In the past data integrity has been an important topic and is an increasingly important focus for FDA and EU regulators. The architectures employed by life sciences firms must be designed to facilitate consistent oversight and well-maintained compliance.

Because these data structures are often complex, many organizations work with third-party consultants who can help them perform IT infrastructure qualification on a diverse range of components and subsystems. Improving the viability of your IT and embedded systems through all phases of the development lifecycle is imperative.

What is Component-Based Qualification?

Many IT systems span the boundaries of more than one organization or facility. For instance, your supply-chain tracking implementation probably accounts for different suppliers, transit arrangements and shipment statuses. Although such a system might not directly control how offsite operations, such as remote warehouses, are managed, it can nonetheless serve as a critical part of your overall quality assurance implementation.

By keeping track of critical process components, supply-chain IT networks play vital roles in pharmacovigilance and batch validation. Still, the scope of these networks may make them difficult to manage.

Component-based qualification is designed to simplify the task of validating an entire distributed or interconnected network. Consultants who address the compliance issues associated with individual IT architectures / infrastructures may make it easier for companies to improve their production strategies effectively in the long run.

Targeting Network Components

Even the simplest networks are complex. A small corporate intranet that only accommodates a few users or automated manufacturing machines still contain numerous potential attack points and security vulnerabilities.

For many firms, unfamiliarity with the technical nuances of network security makes it hard to know where to start when striving for compliance with vital regulations such as 21 CFR Part 11, 21 CFR 210 and 211 and 21 CFR 820 or with the recommendations of the ISPE’s GAMP 5.

IT qualification may help companies gain a better understanding of how to change routine practices in order to meet compliance obligations. In addition to qualifying existing physical and virtual networks, consultants can help firms address the weaknesses of specific applications and hardware components like routers and switches.

Tackling the Broad Scope of Network Compliance

IT infrastructure qualification also helps firms plan for the future. While the scope of regulations changes on a routine basis, the IT systems and technologies that are affected by such rules change even faster. Are your current quality assurance strategies capable of keeping up with new technology compliance needs?

By identifying risks on a regular basis, firms that employ complicated networks or frequently upgrade to new technologies can do so in a fashion that promotes consistent computer systems validation. As part of this process, some organizations gain increased familiarity with pertinent cybersecurity rules which are essential in maintaining market relevance. To learn more about GxP cybersecurity, read this article.

GxP-CC is an experienced team of compliance consultants helping those firms in the medical device, pharmaceutical and dental lab industries achieve compliance through customized GxP compliance strategies. Contact them today to discuss your compliance needs.

About this author:

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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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