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Marion Lepmets
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Introduction Last week we reached an important milestone – the SoftComply Risk Manager on Jira Cloud was awarded the Cloud Fortified badge by Atlassian. The SoftComply Risk Manager is the only product risk management app on Jira and the most customisable one with Risk Management guidance, multiple views to work in and compliant Risk Reporting. To learn more about the SoftComply Risk Manager...
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Why Confluence? Or perhaps the first question should be – why quality management? Most medical device companies need to have a compliant quality management system in place to assure consistent quality of their product. Quality management system consists of a number of written procedures and a multitude of records that...
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Introduction Risk Traceability is a great way to get a quick overview of the completeness of risk management process and it is often used in the regulated industries. The traceability matrix shows the coverage of risks by mitigation and verification actions. For example, in the medical device industry, both the FDA...
