User Requirements Specification – Manufacturing Software Validation

A User Requirements Specification (URS) document may be created for all new or replacement computerized systems as defined in the Software Development Life Cycle document and may also provide the basis for the system design and Process Flow Diagrams. The purpose of the URS is to define the company’s interpretation of the projected users’ solution[…]

Business Requirements Specification – Manufacturing Software Validation

The Business Requirements Specification (BRS) document defines what the system should be designed to do. The system functionality should be designed looking from different perspectives such as from the information flow, system environments and business processes perspectives. The focus of the BRS should be from the business perspective, not on the specifics of implementing the[…]

Detailed Design Specification – Manufacturing Software Validation

The Detailed Design Specification (DDS) describes how the hardware and software functionality identified in the Functional Specification will be developed and implemented. The Hardware DDS is a description of the hardware on which the software resides and how it is to be connected to any existing system or equipment. Where possible, hardware used should be[…]