Comments in response to the US Food and Drug Administration (FDA)’s draft guidance on software assurance for computer and data processing systems associated with medical device production have asked the agency to align some of the language in the document with the recent International Council for Harmonisation’s (ICH) Q9 guidance, exclude system lifecycle tools from the guidance and include information on cybersecurity.
 
The draft guidance details a risk-based approach to “establish confidence in the automation used for production or quality systems, and identify where additional rigor may be appropriate” as well as steps for validating the software and its appropriate use...[RAPS]