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COMPLIANT SETUP ON ATLASSIAN STACK
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What is a simple setup of Atlassian tools when you are operating in the regulated domains like MedTech, Pharma, Aerospace or Automotive? There are many applications to choose from: Jira Software, Jira Core, Confluence, Trello, Bitbucket + the myriad of apps on Atlassian Marketplace.

This blog post describes a basic compliant setup of tools on Atlassian stack that you might need to get started.

This is by no means the final list of tools and you can always add additional apps to automate more and make your life even easier.

In this blog post we look into the Atlassian apps that support the following activities:
* Requirements Management,
* Project Management,
* Documentation Management,
* Quality Management,
* Risk Management,
* Task Management,
* Access Management.

In the blog post we provide you with an intro to each suggested app together with their pricing.

...to continue reading...
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FDA 21 CFR 11 COMPLIANT QMS SOLUTION ON CONFLUENCE
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SoftComply together with Comalatech and Clearvision are happy to present the very first FDA 21 CFR 11 compliant electronic Quality Management System on Confluence!

This Confluence based solution includes a full QMS documentation, digital document control with document approval workflows and e-signatures as well as compliant access management. The solution is pre-configured, maintained and hosted on AWS according to your company needs.

To learn more about this solution, please visit MediCompli product page, read a short blog post about the solution or take a look at the MediCompli video where we introduce the features of the solution.

In case of interest or to arrange a call to learn more about it, please contact us.
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NEW FEATURE OF SOFTCOMPLY RISK MANAGER ON CLOUD

SoftComply Risk Manager on Jira Cloud now supports user created "link type" columns in the Risk Table.

This feature enables users to map various existing Jira issue link types to the risk management table. In addition to our existing Mitigation links and Verification links columns you can now create similar columns yourself for, e.g. "Blocks" or "Relates" or any other link types.

How can I benefit from it?
Now risk managers can set up more complex traceability by, for example, creating separate risk projects for hardware and software risks, and connecting those risks with the new link columns feature in the overall risk management table.

Feel free to add the new link type columns in system administration view for creating custom links between risks and other existing Jira issues as needed.
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Join us at Atlassian Summit on March 31 - April 2

You can find us at the Expo hall, stand #1319. Looking forward to seeing you there!
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As Summit Sponsors, we are able to offer you a 25% discount of your Summit pass! Contact us at SoftComply to get your discount code.
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DMEA in Berlin, April 21-23. Hope to see you there!
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Useful Reading on MedTech, Compliance & Atlassian
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1. Can your Risk Management Prevent a Recall?
2. Three tips for implementing the MDR
3. Webinar recording on MDR & GDPR
4. Latest news from Atlassian Ecosystem
5. Atlassian Platform Roadmap for Developers
1. Can your Risk Management Prevent a Recall?
2. Three tips for implementing the MDR
3. Webinar recording on MDR & GDPR
4. Latest news from Atlassian Ecosystem
5. Atlassian Platform Roadmap for Developers
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Recent posts on SoftComply Risk Manager & SoftComply eQMS that you may want to check out:

On Safety-Critical Risk Management on Jira:
* How to set notifications for your risks in Jira
* New Features of SoftComply Risk Manager and Risk Manager Plus
* Validation Packages for SoftComply Risk Manager and Risk Manager Plus
* Managing Safety-Critical Product Risks in Jira
* How to mitigate Medical Device Risks in Jira
* Hazard Analysis & FME(C)A on Jira
* What is FMEA?

On Quality Management on Confluence:
* How SoftComply eQMS helped speed up the CE-marking - Case Study
* Don't be a "victim" of your Quality System!
* SoftComply eQMS for Medical Device companies on Confluence
* How to set page level restrictions in Confluence

On Regulatory Compliance of Medical Devices:
* On FDA, Compliance and Cloud tools
* Overview of Medical Device Software Regulations and Standards
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RiskManagerPLUS Logo

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:

The new MDR states that Quality System documents need to be searchable. You can now implement a compliant Quality System documentation on your Confluence Cloud! Access the free trial version directly from the Atlassian Marketplace and/or contact us to get a demo & discussion about the content of the product.
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Risk Manager logo no company name

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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