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What's New in July 2021

As most of you know, Confluence and Jira are completely dynamic - everything you see is always up to date. But sometimes we may want to keep some data static and for that purpose we have released a brand new app on Confluence Cloud: The SoftComply Static Snapshots app. You can now capture and freeze the data on your Confluence page, including Jira macros, to approve the static content and to track progress. Feel free to try it out & let us know what you think!

We are often asked how to manage requirements in Confluence and Jira in the regulated domains. We just published a blog post about it that provides you with an overview of how to manage requirements with Atlassian tools.

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Requirements management in the regulated domains such as medtech, automotive or aviation has certain differences compared to the agile development. Jira Software with its easy to use backlog view and work boards suits best for managing requirements in the agile world. For the regulated domains it might be better to use Confluence in addition to Jira. In this blog post, we will describe how to use Confluence and Jira for requirements management in the regulated domains.

The main characteristic of agile development is, unsurprisingly, agility. While you are getting all ideas about and feedback to your backlog you are continuously prioritising and managing the backlog. In other words, your requirements are not fully analysed and may still change during the development phase. In the regulated domains, however, requirements need more control. Changes to requirements have to be analysed and follow a defined process of revision and approval by specific parties within the organisation. This is the reason why the requirements for the requirement management systems also differ based on the domain you are working in.

There are certain advantages of using Confluence for the requirements management in the regulated domain compared to Jira.

In Confluence:
* you can easily see the change history by using Confluence page versions diffs;
* it is easier to write requirements in. Adding images, diagrams, macros, etc and using wysiwyg editor is more user-friendly than the Jira issue editor;
* Confluence page templates help adding control over your content;
* you can add compliant doc approvals to Confluence pages with apps from Comala portfolio;
* requirements can be exported easily into different formats with different styles as needed;
* requirements are all in one place with easy to use structure. Organising and grouping requirements is simple within a Confluence space. Just drag and drop to change the structure;
* it is easy to differentiate drafts and approved documents. Keep drafts and approved documents in separate spaces with separate access permissions.

In case the above-listed aspects are important to your organisation, then you will benefit from using Confluence to manage the requirements.

For the full blog post on how to use Confluence and Jira for requirements management, please keep reading the blog post on our website.

To summarize the blog post, here are the main steps of requirements management in Confluence & Jira:

▪ Use Confluence templates to create you requirements pages in Confluence,
▪ Manage the requirements in Confluence during the analysis phase,
▪ Approve the requirements in Confluence when they are ready,
▪ Create placeholder Jira issues for release planning and tracking from approved Confluence requirement pages,
▪ Use Jira issues to implement the requirements.
Use Confluence templates to create you requirements pages in Confluence,
Manage the requirements in Confluence during the analysis phase,
Approve the requirements in Confluence when they are ready,
Create placeholder Jira issues for release planning and tracking from approved Confluence requirement pages,
Use Jira issues to implement the requirements.
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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!

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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.
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.
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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.
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.
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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
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
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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
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.

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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
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:

Contact us for a demo call of the FDA 21 CFR 11 compliant eQMS Solution on Confluence Cloud.

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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
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.

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