Computer System Validation

Trust Built on Evidence

A vendor tells you their system is “validated”. Should you take their word for it? Under GCP, the answer is - no.

The organization using the system in a trial - sponsor, CRO, or site - remains responsible for confirming that it’s fit for purpose in the specific study. And that confirmation needs to be documented, not simply assumed.

Our latest article on the GoResearch™.live blog takes a closer look at Computer System Validation (CSV): what it actually means, why regulators care about it, and where teams most often lose control.

In the article, we cover:

• Differences between validation, verification, and qualification
• 5 validation stages, from requirements definition to controlled system retirement
• Accountability when something goes wrong - sponsor, CRO, vendor, or site?
• The most common validation mistakes

If your data could one day sit in front of a regulator, it’s worth a read.

👉 Read the full article Computer System Validation in Clinical Trials - Trust Built on Evidence .