User Requirements Specification assuring quality

Typically, managers, their peers, end-users, and those responsible for delivering the system, approve validation plans. Quality assurance may also sign the document. The validation project plan and the requirements specification deliverable, together define the technical and regulatory requirements applicable for a project. 

The drive for these additional requirements has come not from the suppliers but from users, such as the automotive, utilities, telecommunications, software, and aerospace industries which purchase millions of products and services used to produce the goods and services they provide to the consumer. Rather than invoke customer-specific conditions in each contract, the larger purchasers perceive real benefits from agreeing common quality system requirements for their industry sector. Quite often a supplier will be supplying more than one customer in a particular sector and hence costs increase for both the supplier and the customer if the supplier has to meet different requirements that serve the same objective. All customers desire products and services that consistently/ meet their requirements. While the physical and functional requirements for the product or service will differ, the requirements governing the manner in which their quality is to be achieved, controlled, and assured need not differ. Differences in quality system requirements may arise between industry sectors where the technology, complexity, and risks are different. 

Software validation is not separately defined in the quality system regulation. The FDA considers software validation to be the confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled [14]. Software validations have special concerns on software installation, implementation, and utilization. A software validation consists in several tests, inspections, and verifications performed to assure the adequate installation and use of software and that the tasks performed meet all the specifications defined. Software validations must be performed under the environmental conditions to which software will be submitted. This is particularly important in medical devices that are used under special conditions, such as close to or inside the human body. 

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