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Using Software Validation Of IT Systems For FDA Compliance

April 16th, 2014 by

IT Software ValidationCompanies which must work in a GxP environment rely on a range of different technologies to maintain consistent quality and levels of output. In addition to the control software these organizations employ to manage their manufacturing and marketing operations, modern companies also use software designed to implement and maintain valid quality controls.

Naturally, such software must also be validated in order for the work it does to continually meet applicable FDA regulations.

What Does Software Validation Entail?

Application software can perform a number of business-critical functions. These systems are used to maintain client records and requirements, but they also drive the creation of consumer-specific databases and bespoke tools. In addition, firms use application software for behind-the-scenes work, such as enterprise resource planning, computer-aided quality and general document management.

Firms that employ software validation for FDA compliance may choose to concentrate on any or all of the aforementioned business functions. By following ICH and FDA risk-management guidelines, active GxP companies can ensure that their software packages or operating procedures aren’t hiding potential security vulnerabilities. This is essential to maintaining compliance with FDA guidelines that could limit product marketability.

How Should Validation Work?

There are many ways to validate a system, but most effective approaches take a comprehensive look at existing implementations as well as ongoing developments. In short, it’s not very helpful to adopt operating standards for new applications without actually addressing existing problems in old software architectures. Unfortunately, some firms feel torn between the drive to keep up with technological progress and the need to maintain compliant legacy systems.

Forward-thinking companies usually stay on top of their software-compliance obligations by using risk-based testing strategies. Consistent testing of productive systems allows a firm to identify problems as they arise yet still maintain relatively high service availability for software tools. Because test-heavy strategies are good at gauging the vulnerabilities of software in real-world scenarios, they may be more appropriate for pinpointing valid areas of concern.

Implementing Software Validation Effectively

Stress-testing can be a major struggle after the fact. Firms that try to overhaul their database systems or stock-management applications, for example, may quickly find themselves overwhelmed by the sheer volume of work such retroactive procedures entail.

Even if your firm already uses some kind of internal software validation for FDA compliance, it may behoove you to work with outside consultants. Bringing in external assistance is commonly accepted as an efficient way to tackle necessary compliance modifications to existing systems.

Furthermore, an impartial viewpoint may make it easier to obtain an accurate perspective on whether the operating standards you’re accustomed to are at odds with ever-changing GxP cybersecurity regulations. Your own staff’s ability to maintain appropriate software validation practices as time unfolds could depend on whether they get a head start with the help of an expert now.

GxP-CC is a team of global experts working with companies in the medical device, pharmaceutical and dental lab industries to attain and maintain regulatory compliance. Contact them today to discuss your particular compliance strategy 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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