How I came to hate Excel & decided to develop an automated Risk Management tool for JIRA
Part I By Matteo Gubellini, VP of Regulatory Affairs of SoftComply* “Ok, let’s follow a few of these risk mitigation actions down to outputs and verification activities” says the auditor. Typical question. Actually there couldn’t be a more typical audit question. Traceability. We have been here dozens of times. And every time it’s the same […]
Cloud-Based SaaS Tools & Software Validation Compliant with Medical Device Regulations
The continued rise in the use of cloud-based and SaaS (software as a service) tools adds further challenges to the already complex domain of medical device software development that needs to adhere to regulations. How can medical device software developers and healthcare providers benefit from cloud computing while being compliant with regulations that require full control over the software […]
