The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: September 28, 2021 at 8:30am to September 29, 2021 at 4:30pm
Street: Compliance Online, 2479 E. Bayshore Road
City/Town: Palo Alto
Website or Map: https://www.complianceonline.…
Event Type: seminae
Organized By: Complianceonline
Latest Activity: Aug 22
Through a wide variety of regulations, standards, and guidance, the U.S. FDA and other global regulatory competent authorities are increasingly focused on software used for numerous regulated purposes. Such uses include the management and analysis of clinical studies, product development, manufacturing, and the automation of Quality System elements such as complaint management, CAPA, management review, risk management, and document control. Each system within this scope must have evidence it was validated for its intended use.
With the dual purpose of ensuring regulated software contributes to product safety and efficacy and of improving organizational compliance, regulatory authorities face not only the ubiquitous incorporation of these systems but increasingly complex technical environments. From their point of view, companies using software for regulated purposes also see a rapidly evolving technical landscape and a maturing regulatory environment, with increased technical competence on the part of interested third parties. The confluence of these two perspectives places burden on both parties to “up their game” in terms of relevant regulatory frameworks, process discipline, and technical ability.