Why is Computer System Validation Important in FDA Regulated Industries?
Why is Computer System Validation Important in FDA Regulated Industries?
Asking why ComputerSystem 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.
All-encompassing term
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.
References:
http://www.stsv.com/pdfs/STS_CSV_article.pdf
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm
Thanks & Best Regards,
John Robinson
GlobalCompliancePanel
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
Web: www.globalcompliancepanel.com
Email: john.robinson@globalcompliancepanel.com
John Robinson
GlobalCompliancePanel
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
Web: www.globalcompliancepanel.com
Email: john.robinson@globalcompliancepanel.com