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Getting to Know FDA Software Validation Principles

October 3rd, 2014 by Henry Macartney

FDA Software ValidationHow can your firm validate its software effectively when it's such an integral part of everything you do? Today's GxP-regulated organizations employ software for stock tracking, supply chain management, document maintenance, compliance evaluation and a host of other endeavors. As such, it can be difficult to even know where to begin your validation efforts.

Luckily, you're not entirely without resources. In addition to being able to work with compliance consultants to assess your IT architectures and embedded systems, you can refer to FDA guidance documents. Of course, it doesn't hurt to approach these official publications with some assistance. When using such guidance documents one must ensure that the guidance you are using is current and reflects ‘state-of-the-art’ technology.

Relevant FDA Publications Reveal the Scope of Validation

If you're looking for a place to start, the FDA's General Principles of Software Validation is an option. As its title implies, this document covers a number of the basic principles that the FDA applies in judging the efficacy of different software validation methodologies.

The General Principles of Software Validation also define what software needs to be validated to earn FDA approval. Although many people naturally focus on the user applications that process documents and perform other high-level tasks, the FDA also requires validation for software used as a part of medical devices, software that is itself used as a medical device, software used to produce medical devices and pharmaceuticals and any software used in quality systems associated with the pharmaceutical and medical device industries.

This broad scope generally prompts firms to adopt a strategic approach in order to ensure effective CSV compliance for their diverse software.

What Strategies Does the FDA Recommend?

Although the FDA doesn't formally endorse specific validation methodologies in this document, it does promote the general usage of the software development lifecycle, or SDLC. This comprehensive approach is designed to help firms implement strategic risk management practices that take the FDA software validation principles into account along the way. Furthermore, since the introduction of the FDA initiative Pharmaceutical cGMPs for the 21st Century - a Risk-Based Approach, the use of risk management in the industry has become increasingly important and continues to play a significant role in validation strategies employed by companies world wide.

In most cases, software validation efforts can and should occur at multiple points throughout the lifecycle, but individual applications of these principles should always be commensurate with the compliance demands of the systems and software in question.

The FDA also makes mention of something called the Least Burdensome Approach. In brief, this concept means that the agency is open to suggestions from regulated organizations about the most effective methods for ensuring compliance in specific situations. These suggestions must be delivered via formal comment submissions to the agency.

From Guidance to Implementation

Remember that the FDA's General Principles of Software Validation is just a guidance document; it's neither comprehensive nor equivalent to legislation. In order to apply these concepts correctly, firms usually have to make in-depth assessments of the way they operate and adapt the principles to their own needs. Throughout this process, it's essential that they generate the documentation they'll later need to support the viability of their actions.

Even with guidance documents, FDA Software Validation Principles can be difficult to follow. GxP-CC consultants are extremely familiar with FDA rules and regulations, and they possess numerous IT credentials. Let them help you implement a system that satisfies regulatory demands by using industry-proven methodologies. Contact them today to learn more about what really goes into CSV compliance


Posted in CSV Compliance, FDA & European Regulations, FDA Software Validation, GxP CC, Least Burdensome Approach, SDLC, Software Development Lifecycle

About this author:

Henry Macartney

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