We are often asked what are the must-have apps on Confluence and Jira Cloud for the regulated industries to manage requirements, documents, risks and tests. We just published a blog post about it that provides you with an overview of these apps and their pricing together with their underlying Atlassian Cloud tools.

The SoftComply Static Snapshots app enables you to capture and freeze the dynamic data and macros on your Confluence pages. With this app you will be create a Confluence page with the static content knowing that nothing will change on the page in the future. Feel free to try it out & let us know what you think! You can export the snapshots to pdf format and we will be adding the diff checker to it soon as well.

With Atlassian’s Server end of life approaching in a few years, most companies are already planning to migrate either to Cloud or to Data Center. Data Center may seem like a natural path to take for the larger (over 300 users) companies in the regulated domains. Nevertheless, there are some regulated industries like the medtech that are more fragmented and have smaller innovative companies that may wish to go with Cloud.

This blog post aims to describe the six must-have Cloud apps for these regulated product development companies who prefer to stay or move to Cloud.

Best to start from your basic requirements like:
Requirements management
Project management
Documentation management
In order to fulfill those requirements, we suggest you select Jira Software and Confluence.

Now that we have basic Atlassian tools in place, let’s add some more features to our setup. What are the tools that support us in:
Document approval workflows & e-signatures (compliant with FDA 21 CFR 11);
Quality management system (ISO13485, IEC62304, ISO14971, FDA 21 CFR 820 compliance);
Product risk management;
Test management.

These requirements can be solved by adding features on top of Confluence and Jira, in other words we need to add Confluence and Jira apps. To learn more about the apps that support compliance on Atlassian Cloud, please keep reading the blog post on our website.

Below is the summary of the apps we recommend for compliant and paper-free setup on Atlassian Cloud together with their pricing:

Having worked with Jira and Confluence, am sure you have enjoyed the integration between the two. The way you can easily pull data from Jira to Confluence by creating macros on your Confluence page with all the data from Jira that you want to display is absolutely wonderful.

Now, every time you refresh the Confluence page, the content of the macro with the Jira issues will be updated reflecting the changes that have been made in Jira. This is a fantastic and seamless way of always being on top of any changes that may have occurred.

But what if you want to keep a report or snapshot of data from a certain point in time to be able to monitor progress or highlight changes afterwards? Say a meeting minutes that has a Confluence macro in it with content from Jira that you would like to store without the Jira issues being updated when you revisit the notes a few days later?

What about Confluence pages that need to be reviewed and approved by your colleagues? At the moment they may be approving a page the content of which is constantly changing. To make sure that the content of the page you reviewed and approved will not change, you should first freeze the data on the Confluence page.

SoftComply, as an Atlassian vendor for the regulated industries where constantly changing data is often an obstacle for compliance, offers an app to solve this issue.

Try out the SoftComply Static Snapshots app to capture and freeze your data in Confluence and let us know what you think!

There are numerous articles in the SoftComply Knowledge-base including:

▪	How-To benefit from the SoftComply Risk Manager features and customization options,

▪	Frequently Asked Questions on why the Risk Manager works the way it does and how you can change various settings,

▪	Additional Tips & Tricks for adding automation on top of the SoftComply Risk Manager features.

In case you cannot join the webinars, feel free to check out the webinar recordings in our YouTube channel about:

▪	Medical Device Regulations & the FDA compliant QMS Solution in Confluence,

▪	Risk Management in Jira with the SoftComply Risk Manager app, and

▪	Establishing Risk Traceability in Jira and Confluence.

Benefits of the SoftComply Static Snapshots for Confluence Cloud:

▪	Capture and Freeze Data in Confluence

▪	Display Static Data in Confluence pages

▪	Approve Confluence pages that do not change

▪	Create Jira macros & freeze the Jira data with the Snapshot

Benefits of the SoftComply Risk Manager PLUS for Jira Server:

▪	Supports Hazard Analysis and FMEA

▪	Supports FMEA with Detectability

▪	Displays risks in Matrices & RPN

▪	Supports FDA approval and CE-marking process

▪	Targeted towards safety critical domain users

For full list of features of SoftComply Risk Manager PLUS, please check out the User Guide. Try it out for free for a month and/or contact us to get a demo & discussion about the features.

Benefits of the SoftComply eQMS:

▪	Full Quality Management System for medical device co-s

▪	On ISO13485, IEC62304, ISO14971, FDA 21CFR 820

▪	Fully customizable with embedded guidance

▪	Reduces the cost of compliance

▪	Most competitive price

SoftComply eQMS on Confluence Cloud:

Benefits of the SoftComply Risk Manager:

▪	Supports any software system/product risk management

▪	For both Jira Server & Cloud users

▪	Fully customizable for any type of risk project

▪	Automated traceability

▪	Support software system/product risk management

▪	Most competitive price

For full list of features of SoftComply Risk Manager, please check out the User Guide. Try it out for free for a month and/or contact us to get a demo & discussion about the features.

What's New in September 2021

SIX MUST-HAVE ATLASSIAN CLOUD APPS FOR THE REGULATED INDUSTRIES

SOFTCOMPLY STATIC SNAPSHOTS APP

SOFTCOMPLY KNOWLEDGE-BASE

There are numerous articles in the SoftComply Knowledge-base including:

VIDEO CLIPS ON BUILDING COMPLIANCE ON JIRA & CONFLUENCE

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