Welcome back to the first Morris Medical Monday article of the new year. I hope you had a great holiday season. For anyone who is new to our blog, this a weekly series for medical device development companies (and companies who are related to such companies), providing some useful information about Polarion solutions and Polarion extensions.

Today we will continue on the subject of Polarion’s MedPack extension, and have a look into MedPack’s SOUP Work Item.

Soup

Description

A description of a software component of unknown provenance (SOUP) used in the project, according to clause 3.29 of IEC 62304:2006. Any issue of this type must be linked to the software item that is implemented by the component.

Workflow Steps

The SOUP Work Item uses the standard Evaluation Workflow.

Traceability & Impact

A SOUP Work Item must be traceable to a Software Item Work Item and a Architectural Design Work Item and has an impact on an Integration Test Work Item and a Hazardous Situation Work Item.
For more information on traceability and impacts, see the Traceability wiki page.

Attributes

Special hyperlink roles

A SOUP work item has special hyperlink roles to fulfill the requirements of IEC 62304. The following tables lists thos roles.

Hyperlink Role	Description
Published anomaly list	URL of an anomaly list for the used SOUP component
SOUP manufacturer	URL of the manufacturer’s homepage.
SOUP URL	URL of additional information about the SOUP component.

Work Item Attributes

The following custom fields must be filled out before evaluation can be requested:

Attribute Name	Type	Description
SOUP title	Text	(as required by IEC 62304:2006->8.1.2a).
SOUP manufacturer	Text	(as required by IEC 62304:2006->8.1.2b).
SOUP designator	Text	(as required by IEC 62304:2006->8.1.3c).
System hardware and software requirement [B,C]	Text	Example: Processor type, storage type, system-software type,…(as required by IEC 62304:2006->5.3.3).
Functional and performance requirement [B,C]	Text	(as required by IEC 62304:2006->5.3.4).

Evaluation Attributes

The following custom fields must be filled out before evaluation can be finshed and the work item can be closed:

Attribute Name	Type	Description
Reviewer	Text	Person(s) to perform, performing or have performed a review.
Review summary	Text	Short summary of the review. Attachments should be used for additional information.
Last review date	Date	Hidden field automatically set when review has been finshed. Intended to be used for sorting and statistical analysis.

Evaluation Checklist

The following checklist must be filled out before evaluation can be finshed and the work item can be closed:

Checklist entry	Description

Possible Resolutions

The following table shows the possible resolution values when the work item is closed:

Resolution Name	Description
Ready For Use	The SOUP element has been evaluated and can be used in the product.
Obsolete	The SOUP element has become obsolete and is no longer needed.
Discarded	The work item entry has been discarded. No further attention is needed.

For more information about Polarion’s MedPack visit our Extension Portal using following link:

http://extensions.polarion.com/extensions/31-polarion-alm-medpack-iec-62304. I hope you liked this article and you will visit our Blog again when there is another Morris Medical Monday article

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