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In order to have a safe, traceable and manageable Quality Management System in Confluence we need to first take care of our user management. Controlled actions performed by the right people is the cornerstone of developing a safe product.

A controlled Quality Management System is such where a few users can change the QMS documents and the rest of the users can use the already approved documents.

For example, we have a Quality Manager and other employees in the Quality Department who own the QMS documents (update the QMS templates, approve and publish new versions). In addition to that, we have a whole set of users who are actively using the approved QMS templates and SOP-s. In other words, we have two distinct groups of users with different responsibilities and user needs – in the context of Confluence permissions we have two separate groups with different set of permissions. The Quality team must have permission to work with the content and everyone else just views and uses it.

In this blog post we will describe how to set these permissions without implementing fully automated document workflows but by using Confluence’s own features and setting your in-house processes for approving drafts, publishing content, etc.

...continue reading...

For more information, please contact us.

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We are happy to inform you that the SoftComply Risk Manager users can now purchase Validation Package for regulatory compliance.

The validation package consists of the following documents (both templates and executed files): Validation Assessment, User Requirements Specs, Validation Plan, Test Protocol and Test Results.

You can easily repeat the validation protocol in-house to confirm the results of the pre-validation provided by SoftComply.

To read more about the requirement of validating your software tools, please see our previous blog post.

For more information on the Validation Package, please contact us.

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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
▪ Based 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
Based 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.

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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
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Join us in Edinburgh for EuroAsiaSPI Conference in September 2019!

You are welcome to describe your experiences and challenges in the medtech industry as a short paper and participate in the workshop on Safety & Security of Medical Devices.

 
     
 
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