The Product Definition and Revision Control sub-system consists of three modules. First, Itemizer+PLUS define items such as parts, drawings, tooling, and specifications among others. Second, Builder+PLUS defines the relationship between these items and the revisions that justify these relationships. PRS+PLUS documents the “how” of the production process. Together these modules play a critical role in fulfilling Product Lifecycle Management (PLM).
In regulated environments it is especially important to completely define all of the items requiring revision control. If this task is successfully completed then Builder+PLUS will provide comprehensive control of all of the revisions to these items. This revision control is the basis for effective FDA compliance.