Asking why Computer System Validation (CSV) is important in FDA-regulated industries is like asking why an engine is important to a vehicle.
Before going on to get an understanding of this issue, let us understand that there is a difference between the ways in which the term “validation” is used in the general area of computers and that used in FDA-related circles. In the field of computer science, the term means the ability of software to meet its stated requirements. For the FDA, validation of a computer system incorporates all activities that go into a computer system and these should be documented and made available to the FDA. We could use the word “verification” to associate the same meaning and understanding of what “validation” means to the FDA.
The critical importance of computer system validation in FDA regulated industries can be learned from at least two perspectives:
1. When a company is carrying out systematic CSV; it nips potential serious problems in the bud by preventing software problems from reaching production stages and environments. When a problem in a Life Science software application reaches the production environment, this can lead to serious adverse consequences. On the one side, there is the human element of getting the CSV validation wrong, which can result in serious product consequences, which can be disastrous to the patient’s health; on the other, businesses that get their CSV wrong can also face anything from lawsuits and heavy penalties to having to shut shop permanently. Long drawn out court cases can result in serious problems including bankruptcy.
2. FDA’s regulations requiring companies to carry out systematic CSV have the effect of law, which means that companies that come under the ambit of the FDA are legally bound to follow the guidelines set out by FDA’s regulations. When companies fail during an FDA audit; it can invite inspectional observations (“483s”) and warning letters.
The most important element of CSV that companies need to bear in mind is that they need to get their validation right alright; they also need to get it right stage by stage. Some companies have tried the short cut method of overlooking or circumventing a step or two. While this may give them short term savings; their long term costs are far higher than these savings.