This is a document that describes the client's requirements and expectations for a new product or system. It outlines what the system should accomplish and, together with technical and regulatory requirements, forms the basis for the specifications document. The specifications document is usually created by the customer or client.
This document is a component of the V-Model. It consolidates requirements from various sources and supports the design, commissioning, qualification, as well as the operation and maintenance of a system. Critical quality attributes and process parameters are important components that need to be identified to support the quality risk-based process. The specifications can be flexibly designed to meet the needs of a multipurpose operation and are dynamic documents that are updated when changes occur.