User Requirement Specification
User requirement specification or URS is when the user either decides to change the existing equipment or bring new equipment is instigated. It’s necessary that the proposer create a list of details of attributes and bespoke features. This is very essential for the efficiency and safety of the project. This URS is then moved forward for scrutinizing by the main person in charge. This is to ensure that all necessary secondary and support requirements for different functions such as training, facilities etc are identified, measured for.
Scope
This can never be considered as a planning tool and also not mention the usage of the software. Whether the system is a mix of electromechanical or it is a pure software program, the successful combination and execution of 10, 00, and PQ is totally dependent on this User Requirement Specification or URS, containing clear, necessary requirements. After approval of level 1 URS, the engineer starts to plan, design and establish what exactly is required in URS. Once the functionality is documented and approved it forms to be level 2 URS. If the software is to be used, the URS approved is transferred to code writers. Mandatory and traceable documents are to be included completely in URS level 3. This is deemed to be mandatory as it is required to assess software quality.
URS is actually developed from the high-end user extrapolating requirements directly from the production process. These extrapolating requirements of users are then passed to engineer who people to convert the requirement into a complete package. The package made by them always includes different functions that are purchasing, installing, and operating etc. This is not always adjusted to mere direct requirements but also it has lots of indirect requirements. These include manpower, testing, training etc. These indirect requirements are to be recognized researched and investigated each one specifically. In URS this should be specified fully. This should be specified either as fully satisfied or not.
Life cycle function testing
These needs and tasks have to be inscribed in such a way that it verifies the design for purpose. It involved referring to different departments. To functional specification, design specification, and to different testing specifications. The design of URS is unique as it should be active until the process of Design Qualification.
URS Justification
They should be comprehensive in nature. Each and every requirement of the product is to be identified example, product safety, purity, quality, etc. The quality assurance group has a great role in this to verify each and every requirement in the right way. It’s necessary for QA to verify and approve its requirements accordingly. They should be approved of any changes in requirements identified because it affects the project widely. After the approval of QA, its sent for Design Qualification or DQ. Their objectives are deduced into two 1) Documented verification that each and every design requirement of the URS. 2) Identification of critical individual critical components that directly can meet the requirements.
Level 1- details of end-user operability
Level 2- details of functionality
Level 3- software functionality interface
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