The EU has proposed a new regulation on cybersecurity. While this regulation is not specific to the health sector, health is mentioned as critical infrastructure in the proposal. The proposal would provide a revised mandate, objectives, and tasks for ENISA, the “EU Cybersecurity Agency.” The new tasks include: Facilitating the establishment and take-up of European...Read More
SoftwareCPR now has a validation blog at the link provided. The latest entry as of 18-Oct-2017 contains some Retrospective Validation Tips provided by SoftwareCPR founder Alan Kusinitz. Earlier entries relate to Part 11, Agile methods, and Health IT. ValidationCPR BlogRead More
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Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.