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What Goes into CSV Compliance?  

September 5th, 2014 by

Computer System ValidationMost of the more complex computer systems employed by life-sciences firms are in some way customized. Even those who rely on vendor-assembled systems often find themselves having to tweak software settings and hardware architectures to accommodate their specialized needs. This customizing of the computerized systems is usually undertaken with the help of the vendor.

For instance, due to certain special circumstances of requirements, your firm may end up installing a specialty open-source operating system, like Scientific Linux, to take advantage of its built-in analytical and parallel processing capabilities. On the other hand, you may decide to work with closed-source or proprietary software specifically designed for controlling your unique brand of manufacturing equipment.

In either case, the need for CSV compliance is paramount. However, the nature of complex computing solutions can make it difficult to manage without external expertise.

What Requires Computer System Validation?

Compliance guidelines and regulations aren’t limited to the software you use. The physical computing infrastructures you employ must also be qualified. For instance, if you rely on remote data centers that store your production batch data, their access control methods, database technologies and hardware implementations must stand up to in-depth oversight and inspection from regulators. The embedded systems and access points within your plant equipment also have to meet certain governing requirements.

While regulations are already complex to begin with, the very nature of computer systems makes compliance even more difficult. It’s critical that you validate the entirety of your software implementations as well as the systems upon which they run. For many firms that lack computer-specific expertise, ensuring CSV compliance may be quite difficult.

Critical Points of Focus

Concerns like information security often win the most attention, but issues such as data availability and electronic signature validation are also crucial areas of focus for agencies like the FDA. Even if your systems satisfy the most basic requirements, they still need to be robust enough to ensure that data can be recovered following losses. Some firms fail to consider robustness because it’s not a high-profile issue.

Unfortunately, most firms lack the resources to evaluate their compliance efforts in a comprehensive fashion. Those who use open-source software may be subject to massive vulnerabilities, like the Heartbleed bug, while others who stay closed-source often lack the systems knowledge to determine whether they’re even at risk.

Even worse, it’s hard to subject your systems to effective stress testing when they’re being used for live production. This often translates into insufficient time for testing  between manufacturing runs.

Organizing Your CSV Audits

Compliance consultants have a major advantage in that they know what to look for. Their primary focus is on auditing; they can perform system-wide software tests and attack simulations more rapidly than a firm that has to wrestle its attention away from its normal operations can. In the same vein, their familiarity with complex record-keeping regulations, like 21 CFR Part 11, enables consultants to make targeted improvements and resolve outstanding issues.

By taking advantage of an outside perspective, you can improve your CSV compliance efforts and possibly learn about software tools and methodologies that could increase your operational efficiency.

With decades of combined experience and a deep-seated understanding of various computer systems and their role in the life sciences, GxP-CC consultants have the experience required to improve the way you deal with critical data. Contact them today to discover more.

 

About this author:

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Dr. Macartney began his career within the medical device and pharmaceutical fields where he was involved in research and development before moving to the central computer division of the company’s research division located in Upper Bavaria, Germany. In 1996 he started his career in the consulting industry. An industry-wide recognized expert who has issued various publications supporting industry standards, Dr. Macartney is also referenced by the National Academy of Sciences.

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