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 […]
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 […]
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 […]
10 Insider Tips from a Notified Body on MDR, AI Act, Audits & Software Tool Validation
If you’re a medical device manufacturer, you already know that compliance isn’t a walk in the park. It’s more like a hike through regulatory terrain with the occasional mountain lion (metaphorically speaking). But don’t panic. We’ve distilled insights from a recent expert-packed webinar to help you navigate the wild world of EU regulations – with […]
Risk Management Software: Buyer’s Guide for 2025
INTRODUCTION If you are a risk management professional or business owner, you understand that organizations today face a complex risk landscape driven by technological advancements, evolving regulatory frameworks, and globalization. Developments in AI, cloud computing, and IoT have introduced significant risks, with cybercriminals using these same tools to launch more sophisticated attacks. According to the […]
Compliance Workshop Recap from Team25
Compliance is (finally) on everyone’s radar now that Atlassian is targeting business teams and business users in specific verticals and everyone is talking about solutions rather than apps. This is also why SoftComply hosted the 3rd edition of the Compliance Workshop on April 10, 2025 during Atlassian Team event. The workshop’s title was “How to […]
