This weekly series brings medical companies and companies who are related to medical companies useful information about Polarion and Polarion extensions. Last week, we looked at the basic's of Polarion's MedPack solution for medical device developers.
Today we will have a general look into MedPack Wiki Spaces.
MedPack Wiki Spaces
In addition to the Help Wiki space, MedPack ships with four pre-defined Wiki spaces, each with a dedicated purpose.
The figure above shows the relation between the Wiki spaces. The spaces on the left contain pages to analyse Work Items and work progress, while the spaces on the right hand side are entry points for a regulatory view. The latter are especially helpful for notified body employees and auditors, as they provide a view onto the Work Items from the regulatory perspective, using the terms and terminology from the medical and software standards.
The Product Documentation Wiki space shows relevant product information compiled from Work Items and their attributes grouped together in a logical manner. This space has special support for PDF export, so that complete, paper-based documentation can be created with a single click.
The Project Progress Wiki space contains pages that show information with a focus on the overall progress of the project. It supports the management by providing Work Item traceability coverage and review status information.
The Regulatory Records Wiki space gives an entry point to look at MedPack from a regulatory and quality management perspective. It lists all major plans that a software team must provide to be compliant, and provides links to both further documents such as process description or standard operating procedures as well as links to the Product Documentation wiki space. So with just a few clicks, one can proceed from the regulatory top-level-view to the concrete Work Items.
The Process Description Wiki space provides templates for mandatory process descriptions. As these are always company-specific, MedPack does not provide much content here, but these pages are linked from other spaces, especially the Regulatory Records space, so that MedPack and Polarion ALM can be used as the first source and entry point for all aspects of medical software development.
The figure below shows which roles get benefit and will use which Wiki spaces.