How Computer Systems Validation Can Make or Break Your Business

By Gary Marshall, Director of Regional Operations

What Is Computerized System Validation (CSV)?

Computerized System Validation (CSV) is defined by the FDA 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.”

In layman’s terms, CSV is the line of work where regulated companies validate their software applications by executing different validation projects in order to prove their software is working properly.

Why Is Computerized System Validation Important to My Business?

There are many reasons as to why Computerized System Validation is important, especially if you work in a highly regulated industry. If your business does fall into that category, it is likely you’re familiar with the validation of methods, processes, equipment or instruments to ensure your science is of high quality. CSV is no different. CSV is integral to ensuring the quality and integrity of the data that supports the science.  If the FDA or any other regulatory body inspects your company, you can guarantee they will check on this.

Common Computerized System Validation Mistakes

The whole goal of CSV is to prove that computers and software will work accurately on a consistent basis in any situation as it complies with relevant regulatory bodies.

The timeline of CSV testing activities is never ending. CSV happens throughout the whole software development lifecycle (SDLC) – from system implementation to retirement.

With that being said, this leaves ample opportunity for error. Some of the more common ones in the industry include:

  1. Poor Planning – We run into poor planning issues when there are insufficient resources and inaccurate timelines.
  2. Inadequate Requirements – Typically, we see too few, too many, too detailed, or too vague.
  3. Test Script Issues – This is commonly seen with execution errors, inadequate testing, poor test incident resolution, over reliance on vendor testing.
  4. Project Team Issues – Associated issues include poor buy-in from all stakeholders, unavailability of key personnel at key times.
  5. Inadequate Focus on the Project – Resources often are pulled off to their day jobs, insufficient managerial support.
  6. Wasting Time on Low Value Testing Activities – There are typically inadequate risks and critical assessments.