3 things regulated industries must consider when setting up their organisations on Atlassian Jira and Confluence
New in SoftComply Risk Manager on Jira Cloud
In addition to being able to apply the SoftComply Risk Manager to any Jira projects – the new feature of the Risk Manager on Jira Cloud we released in December 2020, there are another two new features we released just now. NEW RISK PROJECT CREATION WIZARD When you are creating a new risk project with […]
Top 3 Features of an Electronic Document Management System for Medical Devices
As all the rest of your work has moved from manual to electronic, your Document Management System (DMS) should also be fully electronic. Preferably on the same platform you are using for the rest of your medical device development related work. For example, if your software development team is using Jira, it is only natural […]
How to apply SoftComply Risk Manager features to any Jira project
Wouldn’t it be cool to keep everything in Jira – your backlog, your test cases and your risks all in Jira? Yes, but you could do that for years already. But what if all that can be done in a single Jira project? That would be truly awesome! You can now do it with the […]
Medical Device Compliance & Atlassian Cloud
On the 16th of October 2020, Atlassian announced radical changes to their offering. From February 2nd 2021, Atlassian will not sell any new Server licenses for any of their products. A year later, in February 2022, it will not be possible to upgrade or downgrade your Atlassian Server product tier. From February 2023, it will […]
Compliant PPE Production
The Regulatory Compliance Journey of XRGO Nathaniel Victor, CEO of XRGO: “We got involved in PPE manufacturing as a goodwill donation/gesture of time, energy, products and financial support to the hospitals and local municipalities. Early on, our suppliers in China informed us that COVID-19 was serious and they advised that we protect our staff and […]
How to Use Confluence Pages as Templates
Summary SoftComply has released a new Confluence Server macro within the SoftComply eQMS app that allows the user to use any Confluence page as a template, copying it automatically into the existing space at a click of a button. Features include the addition of prefixes, suffixes, timestamp and more. This bypasses the use of Confluence […]
How the MediCompli Solution helped Cibiltech become FDA 21 CFR 11 Compliant on Atlassian Confluence
Customer Story on the MediCompli Solution at Cibiltech Cibiltech Cibiltech is a French medical device company developing an AI based personalized medicine solution for better patient care. Their most recent solution is aimed at post-transplant kidney monitoring for personalized treatment and better decision support. Previous Document Management System at Cibiltech Prior to the MediCompli […]
Why Decompose the Probability of Harm in two – P1 and P2
P1 and P2 No we are not talking about the early Playstation versions… ISO 14971 (2019 version, Annex C) indicates that the probability of a Harm occurring can be decomposed in two probabilities, P1 and P2, where: P1 = Probability of Hazardous situation occurring P2 = Probability of Harm occurring for a given Hazardous situation […]