ProjectBalm, makers of Risk Register, today announced it has achieved SOC 2 compliance, marking a significant milestone in its mission to "take the sting out of risk management." Founded in 2015...
For regulated industries - such as Pharma, MedTech, FinTech and Aviation - compliance isn't optional; it's mandatory. Tools like Jira and Confluence are powerful, but their true potential is only rea...
In today’s fast-paced software development world, managing risks isn’t a luxury, it’s a necessity. Yet, many Agile teams treat it as an afterthought or delegate it to isolated spreadsheets that live ...
In the medical device industry, risk management is not just a regulatory requirement. It is a fundamental practice to ensure the safety, effectiveness and quality of devices that directly impact pati...
...nformation from suppliers and wholesalers that distribute your product. Information from publicly available published scientific literature. One of the most “recent” aspects is cybersecurity s...
👋 Hi Atlassian Community! As someone working on improving how teams manage delivery risks, I wanted to share a key insight: Risk assessment works best when it's integrated into your existing workf...
Hi Atlassian Community! I want to share Risk Radar, a Jira Cloud app I recently created to help teams assess the risks of issues in Jira. In this post, I’ll explain how the formula calculates the ...
Atlassian’s updated Marketplace Partner Program underscores the need for robust security management. With increasing customer expectations around data protection, security, and compliance t...
Hey, there! This week, we’re diving into a Risk Assessment. This report can help teams quickly identify and mitigate potential risks in the workflows. In this risk matrix-style report issues a...
Disasters don’t happen by accident—they happen when risks go unmanaged. 🚨 In safety-critical industries like aviation and healthcare, the cost of poor risk management can be catastrophic. Jo...
I am working on a project to move us from Waterfall to Agile ways of working, including moving off Project Online and using JIRA/Confluence for all our Project Management controls such as RAID regist...
Hi everyone, I'm trying to automate the calculation of the Risk Score field in Jira. The Risk Score is a numeric field, calculated by multiplying Probability and Impact, both of whic...
A mid-sized company in the medical technology sector faced a growing challenge: meeting the stringent requirements of the Medical Device Regulation (MDR) and FDA 21 CFR. As the company expanded, the ...
Work in Jira but hate the manual data import? Think that guesstimating deadlines and rolling with the chaos is just a part of work? Introducing Portfolio Manager (formerly LiquidPlanner) – now with J...
...ust if you are planning to enter the US governative market. The NIST Special Publication (SP) 800 series applies to US federal agencies, organizations and their suppliers/subcontractors when c...
All product development teams let out a sigh of relief when a product is launched. The hard technical work is done, tight deadlines met (more or less), submissions completed and approved. Time to han...
The Digital Operational Resilience Act (DORA) is a EU regulation that entered into force on 16 January 2023 and will apply as of 17 January 2025. Are you ready? What is DORA? The Digital Operatio...
This case study describes the experience of a multinational medical device manufacturer meeting the FDA cybersecurity requirements. The company is operating in the MedTech sector developing a class 2...
Keeping your data safe is vital for every business. One way to do this is by following ISO 27001. But how can we manage these information security risks with a tool like Jira? Let's dive in...
Integrating risk management into the Software Development Lifecycle (SDLC) of a product is crucial to its success. It enhances the safety, security and reliability of your software product. When you ...
...revalent in the information technology (IT) and cybersecurity sectors of regulated domains like the financial industry, telecommunications, public and defence sectors as well as the healthcare domain. S...
ISO 31000:2018 is a globally-recognized standard that provides guidelines for effective risk management. Developed by the International Organization for Standardization (ISO), it aims to help organiz...
At the moment, we use the Risk Register app for our risk management. Here we have the option of assessing risks between Inherent and Residual. This can also be displayed in the heat map. Is this also...
Hazard analysis is crucial in safety-critical product development, especially for medical devices. You can conduct hazard analysis also in Jira - check out the guide below. If you prefer to watch the...
If you’re considering using Excel for your Risk Register, this video explains why that might not be the best choice. Instead, we introduce a more effective alternative using Jira and dedicated risk...
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