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 system functionality. If the new software is to be used in conjunction with or as a change of a current system, the BRS should include a detailed description of the current system. The BRS should also outline non-functional requirements or constraints, and specify user deliverables. Any provisions required for compliance, such as company specific quality initiatives or government regulations, should also be included in the BRS.

New BRS documents may need to be created for new or replacement software systems depending on guidelines established in the Software Development Life Cycle document. Creating new BRS documents will also provide a foundation for the System Design Concept and Process Flow documentation.

InstantGMP™ MD is a medical device manufacturing software system that was designed using Business Requirements Specifications. The software is a full-scope integrated manufacturing system that streams the entire manufacturing process including inventory control, material management, specification control, and electronic batch records. Overall, the software simplifies documentation and approval procedures, increases production efficiency, and provides a centralized system for manufacturing documentation. Furthermore, quality assurance procedures were written simultaneously during InstantGMP™ MD development in order to maximize quality, reduce errors, and ensure GMP compliance.

 

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