Modern medical device regulations are putting more and more emphasis on the management of software tools.
These tools are software packages that are not part of the medical devices themselves, but support the device during its lifecycle.
Nowadays companies use dozens of applications, ranging from accounting tools to email clients to software compilers. Of course not all of them have an impact on the product, so which ones should be validated and how?
The first step for any situation is to assess the software tool for its impact on the medical device. If it can have an impact on the “quality” of the device (in the broader sense), then validation may be required. Consider also that the software tools used to manage your Quality System, including CAPAs, complaints, NCs, requirements, risks, etc., fall into this category.
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SoftComply now provides a validation package for the the SoftComply Risk Manager Server version. Validation package for the SoftComply Risk Manager Plus will become available from February 2019. For more information, please contact us.