Blog

6 Steps to Agile Risk Management Success in Jira for Regulated Environments

Picture of Marion Lepmets

Marion Lepmets

CEO
June 19, 2025

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…

6 Steps to Agile Risk Management in Jira

Subscribe to the SoftComply Blog

Stay connected with SoftComply and receive new blog posts in your inbox.

Risk
Picture of Marion Lepmets

Marion Lepmets

CEO
February 20, 2023
4 Benefits of Having your Risk Register in Jira rather than Excel...
Orthogonal-Agile-eQMS
Picture of Monika Isak

Monika Isak

Head of Growth
February 7, 2023
Our customer Orthogonal describes how to set up an agile eQMS solution on Atlassian Confluence and Jira...
Risk
Picture of Marion Lepmets

Marion Lepmets

CEO
November 21, 2022
Comparison between the risk management apps on Atlassian Jira - the SoftComply Risk Manager and the Risk Manager Plus on Jira Cloud...
Skinuvita Team Tablet© Skinuvita copy
Picture of Marion Lepmets

Marion Lepmets

CEO
November 16, 2022
How to find the best regulatory compliance solution for medtech on Atlassian...
Validation
Picture of Marion Lepmets

Marion Lepmets

CEO
November 3, 2022
Automated Validation of Confluence Cloud...
FDA Software Assurance
Picture of Marion Lepmets

Marion Lepmets

CEO
October 19, 2022

On September 13 2022, the FDA issued a new draft guidance on “Computer Software Assurance for Production and Quality System Software”. This new guidance is intended to supplement the current approach described in the 2002 “General Principles of Software Validation” guidance. This guidance additionally discusses specific risk considerations, acceptable testing...