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What's New in January 2021

We hope you had a fantastic holiday to wrap up 2020 and that the new year has started well for you, your family and friends.

Earlier this week we released a new version of the SoftComply Risk Manager Cloud and in this Newsletter we will tell you what is new there.

You can also read about the most important features for an electronic Document Management System for medical device industry.
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NEW IN SOFTCOMPLY RISK MANAGER CLOUD
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New Risk Project Creation Wizard

When you are creating a new risk project with the SoftComply Risk Manager on Jira Cloud, you can choose between 3 out-of-the box templates: Hazard Analysis, FMEA or a generic template.

The generic template has minimum amount of fixed columns in the risk table view. In case you want to manage project risks, choosing this template provides you with most flexibility - you can build the risk table based on your risk management process needs.

Hazard analysis template is based on ISO 14971 standard and is the best fit for medical device risk management. Since our templates are all fully customisable, it fits perfectly any top down product risk management process.

FMEA template is for bottom-up risk analysis and is used most often in safety-critical product development. This template is also fully customisable.

If you would like to add automation to your risk management, please see our knowledge-base for articles of tips and tricks for SoftComply Risk Manager.

How to disable Harm-Severity lock?

In medical device risk management, risks that have the same Harm should also have the same Severity value.

SoftComply Risk Manager helps keep your risk data consistent by locking the Harm and Severity values for you when you have chosen the Hazard Analysis or FMEA template.

If you change a Severity value of a risk, the SoftComply Risk Manager will now inform you about other risks in the same risk project where the Severity value will also be changed due to the risks sharing a Harm.

In case you would like to manage other risks with the SoftComply Risk Manager, you can now disable this Harm-Severity lock in the "Project Settings".

To read more about these features, please see our recent blog post.
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TOP 3 FEATURES OF AN ELECTRONIC DOCUMENT MANAGEMENT SYSTEM
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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 that your organisation would like to have everything on Atlassian stack including your quality management documents.

Atlassian products are known for their full customizability, transparent pricing and fantastic integration features between Jira and Confluence where you can pull information easily from one to the other using built-in queries and macros.

A fully electronic Document Management System should comprise of:

a) Compliant Quality System documentation,

b) Electronic workflows for Document Review and Approval,

c) E-signatures to electronically approve the steps in the workflow.

TOP 3 FEATURES OF ELECTRONIC DOCUMENT MANAGEMENT SYSTEM:

I COMPLIANCE

Compliance to the major standards and regulations like ISO 13485, IEC 62304, ISO 14971, FDA 21 CFR 820, and more. The system should be 21 CFR 11 compliant if you intend to enter the US market. Read more here.

II AUTOMATION

Automation of the main processes, workflows, concurrent collaboration, traceability, easy linking, dedicated automation for processes like CAPAs, Changes, Training. Read more here.

III CUSTOMIZATION

Customization of most aspects of the system, such as permissions, workflows, content, security, settings, etc. Read more here.

For full article, please read on here.
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REMINDER ABOUT SERVER PRODUCT LICENSES
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Last October, Atlassian announced the End of Server products Support.

As a part of that, Atlassian will sell no new Server licenses starting from February 2, 2021. This is in less than a week!

The important thing to remember is that Atlassian also considers new license sales to be the upgrades from Starter licenses, i.e. from 10 user tier to 25 user tier. In other words, you will not be able to upgrade from 10 users starting from February 2.

In Atlassian's own words:

"Moving from a Starter to a full license is considered a new sale, which means that as of February 2, 2021 PT (the end of new license sales), you won’t be able to upgrade your Server Starter license to a full license. After that point, upgrading will only be available by moving to either cloud or Data Center."

You can read more about this here.
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JOIN OUR WEBINARS & TRAINING COURSES
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Join our webinars and training courses to learn more about Medical Device Regulations, Medical Device Risk Management & implementing an FDA Compliant Quality Management System on Atlassian Stack.
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NEW VIDEO CLIPS ON REGULATIONS & SOFTCOMPLY ATLASSIAN APPS

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.
SoftComply YouTube Channel
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JIRA TRAINING COURSES ON OFFER

Check out & join our brand new Atlassian Jira online training courses!
Jira Courses
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Recent posts on SoftComply Risk Manager & eQMS

On Safety-Critical Risk Management on Jira:
* What is a Risk Management File?
* How to create an Organisational Risk Register with SoftComply Risk Manager?
* Comparison of Risk Management Apps on Jira Cloud
* Comparison of Risk Management Apps on Jira Server
* Hazard Analysis & FME(C)A on Jira
* What is FMEA?

On Quality Management on Confluence:
* How to turn Confluence into a Compliant Document Management System for Medical Devices
* Comparison of SoftComply eQMS & the MediCompli Solution
* How SoftComply eQMS helped speed up the CE-marking - Case Study
* Don't be a "Victim" of your Quality System!
* How to set Page Level Restrictions in Confluence

On Regulatory Compliance of Medical Devices:
* What is MDR Up-Classification and its Extension
* MDR: Equivalence in Clinical Evaluations
* Cybersecurity in Medical Devices
* The Six Must-Have Atlassian Apps for Medical Device Companies
* On FDA, Compliance and Cloud tools
* Overview of Medical Device Software Regulations and Standards
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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:

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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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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