By morrisd

Welcome back to Morris Medical Monday: 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 Software Requirement Work Item type.

Software Requirement

Description

A software requirement according to clause 5.2.1 of IEC 62304:2006. Any issue of this type must be linked to its source, which is either a system requirement or a change request and to the architectural design that implements the requirement.

Workflow Steps

The Software Requirement Work Item uses the standard Verification Workflow.

Traceability & Impact

A Software Requirement Work Item must be traceable to either a System Requirement Work Item, a Risk Control Measure Work Item or a Change Request Work Item and has an impact on a Architectural Design Work Item and aSoftware System Test Work Item.
For more information on traceability and impacts, see the Traceability wiki page.

Attributes

Work Item Attributes

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

Attribute Name	Type	Description
Requirement Category	Enum (Multi)	A Software Requirement has to be classified in one or more of the following categories: – Functional and capability requirement – Software system inputs and outputs – Interfaces between the software system and other systems – Software-driven alarms, warnings and operator messages – Security requirements – Usability engineering requirements – Data definition and database requirements – Installation and acceptance requirements – Requirements related to methods of operation and maintenance – User documentation to be developed – Unser maintenance requirements – Regulatory requirements (as required by IEC 62304:2006->5.2.2).

Verification Attributes

The following custom fields must be filled out before verification 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.

Verification Checklist

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

Checklist entry	Description
Requirement is expressed in terms that avoid ambiguity	Boolean field must set ‘true’, to close this work item. (as required by IEC 62304:2006->5.2.6)
Requirement does not contradict another requirement	Boolean field must set ‘true’, to close this work item. (as required by IEC 62304:2006->5.2.6)
Requirement is stated in terms that permit testing	Boolean field must set ‘true’, to close this work item. (as required by IEC 62304:2006->5.2.6)

Possible Resolutions

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

Resolution Name	Description
Approved	The software requirement has been approved and needs to be implemented.
Not Approved	The software requirement has not been approved. No further action is needed.
Obsolete	The software requirement 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.