Using Jira for Risk Management: 8 Best Practices For 2024
When it comes to managing risks in project management, using Jira for risk management can significantly improve your team’s productivity and effectiveness. Risk management involves identifying, assessing, and prioritizing risks to minimize their impact. With Jira’s flexible tools and plugins, you can streamline this process making it easier to keep track of potential issues and […]
5 Steps To Tracking & Mitigating Project Risks in Jira
Project risk management is crucial for project success, especially important to keep critical risks under check in case of (inevitable) changes. The hidden complexities of a project is the main reason why timelines are not met and the resources are spent mid-way. Here is a quick guide for a Project Manager how to best conduct […]
Supporting Regulated Industries on Atlassian
On May 2, 2024 SoftComply hosted the 2nd edition of Regulated Industries workshop during Atlassian Team event. The workshop’s title was “How to best support Regulated Industries on Atlassian” and was aimed to discuss the customer feedback and best practices of collaboration between Atlassian, app vendors and solution partners to support our customers. For 2 […]
What are the FDA 21 CFR 11 Compliant Electronic Records?
Title 21 of the Code of Federal Regulations, Part 11, also known as 21 CFR 11, deals with the requirements for Electronic Records and Electronic Signatures to be considered “trustworthy” by the FDA. If you work in the MedTech or Pharma sector, you probably have heard about this regulation plenty of times. And if you […]
What is an FDA 21 CFR 11 Compliant Electronic Signature?
Title 21 of the Code of Federal Regulations, Part 11, also known as 21 CFR 11, deals with the requirements for Electronic Records and Electronic Signatures to be considered “trustworthy” by the FDA. If you work in the MedTech or Pharma sector, you probably have heard about this regulation plenty of times. And if you […]
3 Best Jira Cloud Risk Management Plugins Compared [2024]
Comparison of risk apps on Jira Cloud
Software Risk Analysis in Medical Devices
In the Medical Device industry software components, whether standalone or as part of a physical device, must follow the same rules as any other component, i.e. ISO 14971 “Medical devices – Application of risk management to medical devices”. BUT .. but there are significant deviations required by IEC 62304 and the GDA guidance document “Content […]
Risk Management of Off-The-Shelf (OTS) Software
Your software is likely to contain a number of components, items, packages, libraries, etc. not developed directly by your company. It may include open-source or purchased software. Unless you have a very close relationship with the developer and access to the source code, these components are black boxes for you. According to IEC 62304, the […]
Hazard Analysis and FMEA: the Most Common Approaches to Risk Management for Medical Devices
What is the difference between Hazard Analysis and FMEA. Which approach should you use. Comparison and examples.
4 Key Reasons Why you should move your Risk Management to Jira
Risk management in the regulated industries is often viewed as a necessary evil, but what if we approached it as a secret weapon instead? It’s a common misconception that risk management slows down innovation and adds unnecessary layers of bureaucracy. Yet, in reality, effective risk management is the linchpin of sustainable growth and resilience, especially […]
