7 Validation Mistakes You Don’t Know You’re Making

Validation Plan? ?
Test Scripts? ?
Testers and Approvers? ?

Your Computer System Validation (CSV) project is underway.

Or is it?

The Items checked above, in addition to a few other documents, are key to the success of your CSV project.  However within those items, there are crucial details that can easily be over looked or over simplified opening your organization to risk.

Keep in mind the FDA’s general definition of validation is “Establishing documented evidence which provides a high degree of assurance that a Computer System will consistently produce results that meet its predetermined specification and quality attributes.’  Listed below are common mistakes that companies make during their CSV project without being aware they are making them.  We’ll go into some detail about each and offer advice on how to avoid making these mistakes on your next CSV project.  [Read More]