Computer System Validation – How Much To Validate?

March 10, 2014 by

How much to validate is the biggest challenge facing validation professionals and their organizations.  Deciding how much to validate is a delicate balance between satisfying compliance requirements and the time it takes to implement critical technologies.

Why is this a challenge for organizations? 

When you consider compliance requirements you must first consider cost.  Validation is an overhead cost, not a profit driving business activity.   As a result the decision of how much to validate becomes an important question that impacts both time and money.

The second point to consider is the company’s interpretation of FDA or other regulatory agency guidelines.   A lack of understanding of these guidelines often results in 2 scenarios:

1) Over documentation, or too much validation, which increases the time it takes to enable and implement critical technologies. This may result in a delay to market and negative impact on revenues.

2) Not enough documentation, or lack of validation, which presents the risk of failing regulatory audits. This may result in recalls or significant fines, which can also negatively impact revenues.

The final point to consider is lack of resources.  In many organizations, being able to answer the question of how much to validate depends on the professionals themselves.  Not having enough committed resources negatively impacts cost and timing.

For many professionals, achieving the delicate balance between satisfying compliance requirements, and the time required to do so, may mean the difference between passing an audit and losing revenue dollars.

Understanding the principals behind every validation effort and achieving proper documentation that shows your system performs on par with specifications and standards is the first step in answering our question of how much to validate.

To help solve these challenges Compliance Associates is offering a Computer Systems Validation Fundamentals course.  During this training we will teach basic validation principals that will help companies establish a solid foundation for delivering technology solutions FDA regulated environments.

Register for the training course.

Learn more about our validation services.

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