The US Food and Drug Administration (FDA) has issued a draft guidance on software assurance for computer and data processing systems associated with medical device production. FDA said the draft ...

CAPA system Supporting corrective and preventive action (CAPA) practices, a quality system software application for medical device manufacturing has user-friendly and democratic collaboration features ...

Comments in response to the US Food and Drug Administration (FDA)’s draft guidance on software assurance for computer and data processing systems associated with medical device production have asked ...