Functional Value

Automatically generate the Product Record Traceability:

Role displays the product record traceability of associated design elements with their content (artifacts). It automatically enables the Design Traceability of the Design Elements content in the Product Record. Role supports traceability matrix of documents present in design elements (Design Inputs, Design Verification and Design Outputs).

Define Design Elements in Product Record:

Role provides an ability to define the type of Product Record as different design controls: "Design History File" or "Device Master Record" etc. at the time of creating Product Record Template. Role automatically shows the default Design Elements: Design Inputs, Design Outputs, Design Verification and Design Validations. User has an ability to update the display name of Design Elements prior freeze the respective Template. Role automatically populates the design elements in Product Record when created from Product Record Template.

User Experience Value

Automatically generate the Product Record Traceability

Maintain Audit Trails for all Quality / Regulated User actions.