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 Architectural Design Work Item.
The description of the architectural design according to clause 5.3 of the IEC 62304:2006. The architectural design must clarify the relationship between the software system and the software items. Any issue of this type must be linked to a software requirement and the software system and software item entries it describes. An architectural design must only be provided in case of a class B or class C project.
The Architectural Design Work Item uses the standard Verification Workflow.
Traceability & Impact
An Architectural Design Work Item must be traceable to a Software Requirement Work Item and has an impact on a Software Item Work Item, a Software System Work Item, a SOUP Work Item or a Detailed Design Work Item. It can also has an impact on a Software Unit Work Item.
For more information on traceability and impacts, see the Traceability wiki page.
Work Item Attributes
The following custom fields must be filled out before verification can be requested:
The following custom fields must be filled out before verification can be finished and the work item can be closed:
Person(s) to perform, performing or have performed a review.
Short summary of the review. Attachments should be used for additional information.
Last review date
Hidden field automatically set when review has been finished. Intended to be used for sorting and statistical analysis.
The following checklist must be filled out before verification can be finished and the work item can be closed:
Architecture implements all requirements
The Architecture has to implement all System and Software Requirements.
(as required by IEC 62304:2006->5.3.6a)
Architecture supports interfaces
The Architecture has to support interfaces between Software Items and between Software Items and hardware.
(as required by IEC 62304:2006->5.3.6b)
Architecture supports proper operation of SOUP items
The Architecture has to support proper operation of SOUP Items.
(as required by IEC 62304:2006->5.3.6c)
The following table shows the possible resolution values when the work item is closed:
The architectural design has been completely finished.
The architectural design has become obsolete and is no longer needed.
The work item entry has been discarded. No further attention is needed.