Since many of the present generation’s medical devices are run by software; a practical approach is to have this software validated. This validation, also known as software vendor qualification, is a means to ensuring that the software, the heart of the medical device, is compliant with set standards. The principles of this qualification are set out in 21 CFR Part 11.
Why is software vendor qualification needed?
It is generally more economical for medical device companies to buy commercial off-the-shelf software (COTS) than having it developed in-house. Software vendor qualification is the means to ensuring this. This is not only cost-saving; it also saves manpower resources and the time taken to bring the product out into the market. When companies install software that is not built in-house; they need to have COTS that meets some regulatory requirements.
COTS could include software packages like display managers, peripheral interfaces, communications protocols or operating systems. The medical device company needs to have processes that evaluate software packages for their ability to meet intended needs. The companies also need to have processes for software vendor qualification, which will help their products meet strict regulatory requirements.
When should software vendor qualification be done?
An important question that arises with this issue is about when to do the software vendor qualification. If the software is bought from outside, it is understood that it should already have been built to meet standards. What happens once the software starts getting implemented into the company’s systems?
A thumb rule that many medical device companies follow to avoid getting cited from the FDA is this: they ensure that the vendor’s validated system demonstrates “systematic, high quality software specification, development and testing methodologies, together with documentary evidence that they have been followed”. This is the yardstick by which FDA measures software vendor qualification, because to it, any validated system that fails to demonstrate this is considered as not valid.
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