![]() #GAMP 5 SOFTWARE CATEGORIES SOFTWARE#The GAMP Software categories can be open to interpretation. This software could be written in-house and is possibly the highest risk of the software categories as it is customised and there is a higher level risk of errors within the application code. Is software that is generally written from scratch to fulfil the business need. GAMP Software Category 5 – Bespoke software.As a result of this GAMP Category 4 software can require a much higher level of validation than GAMP Category 3. The functionality of the software can be configured to return different outputs depending on the configuration. This is possibly the biggest and most complex category. ![]() – GAMP Category 4 software is software applications that are configured to meet user specific business needs.
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