5 Steps to Implement ISO 27001 ISMS in Jira
Information security isn’t optional anymore. Whether you’re handling customer data at a startup or managing intellectual property at a global enterprise, a single security incident can cost you financially, damage your reputation and destroy customer trust. That’s where ISO 27001 comes in. It’s the world’s leading standard for information security management systems (ISMS) and it […]
How to Implement Governance, Risk and Compliance (GRC) Framework in Jira
GRC (Governance, Risk and Compliance) isn’t just corporate bureaucracy – it’s your company’s shield against costly surprises. Too many organizations scramble during audits, struggle with scattered risk registers, and face regulatory nightmares that could be avoided. Watch the full video above to see exactly how to implement GRC and how a pharmaceutical manufacturer did it […]
How to Automate Confluence Cloud Validation for Medical Device Companies
Medical device companies face a constant challenge: how do you validate cloud software tools that update daily? If you’re using Confluence Cloud for your quality management system, you need validation documentation that keeps pace with Atlassian’s frequent updates. I’ll walk you through exactly how to automate this process using the SoftComply Validation for Confluence Cloud […]
How to Create Risk Reports in Jira and Confluence
Risk reporting isn’t just another checkbox on your compliance list. It’s the backbone of effective risk management that keeps your team informed, your management happy, and your auditors satisfied. When you’re managing risks in Jira, you need clear, current reports that don’t require endless manual updates or screenshot juggling. Watch this video to see exactly […]
How to Implement P1 and P2 Hazard Analysis in Jira for Medical Devices
Do you want to make your medical device risk management more precise? While many companies stick with single probability values in their hazard analysis, ISO 14971 suggests breaking down probability into P1 and P2 components. I’ll show you exactly how to set this up in Jira using nested risk models. Watch the video above to […]
Medical Device FMEA: 10 Steps to Bulletproof Risk Management
Risk management in the medical device industry isn’t optional – it’s literally life or death. If you’re developing medical devices, you need to identify, assess, and mitigate risks throughout your entire product lifecycle. Patient safety depends on it. Watch this step-by-step guide to implementing FMEA for medical device risk management. Last week I covered hazard […]
Complete Guide to Medical Device Hazard Analysis based on ISO 14971 and IEC 62304
Medical device risk management isn’t just another regulatory checkbox. It’s the foundation that proves your device is safe for patients and users. When auditors come knocking, they’ll scrutinize your risk management process more than almost anything else. Get it wrong and you’re looking at serious compliance issues. I’ve put together this comprehensive guide to walk […]
6 Steps to Agile Risk Management Success in Jira for Regulated Environments
Balancing agile development with regulatory compliance feels like trying to mix oil and water. But what if I told you there’s a way to integrate risk management directly into your Jira workflow without sacrificing speed or compliance? Based on a recent webinar with Aaron Morris, I’ve distilled the process into six practical steps that will […]
Why Atlassian Solution Partners Must Pivot to Business Users in 2025
For years, Atlassian solution partners have built successful businesses around helping IT teams configure Jira and Confluence, manage licenses, and handle technical implementations. But that world is rapidly changing. Atlassian is shifting its focus from IT admins to business users in specific departments and industries – and partners who don’t adapt risk being left behind. […]
Beyond Configuration: How Consultants Empower Regulated Industries
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 realized when configured to meet industry-specific regulatory requirements. This is where industry consultants come into play, offering expertise that goes beyond standard configurations – translating […]
