How Computer Systems Validation Can Make or Break Your Business

By Gary Marshall

What Is Computer Systems Validation (CSV)?

Computer System Validation (CSV) is often referred to as software validation. Regulated companies perform validation projects to prove that their software or system is performing the way it is supposed to work, and not performing in ways that it isn’t intended to work.

The FDA defines software validation as “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled” – General Principles of Software Validation: Final Guidance for Industry and FDA Staff.”

Why Is Computer Systems Validation Important to My Business?

There is an endless list of reasons as to why computer systems validation is important. If you work in a highly regulated industry, you’re probably familiar with the process of validation of equipment or machines, and it’s the same deal with validation of computers and software. If something goes wrong with your product of you are inspected by the FDA and other regulatory bodies, it is guaranteed they will check on this.