URS (User Requirements Specification) is a collection of the user expectation for a new or renovated plant, production equipment, instruments, utilities and system functions and operational capabilities, the applicability of GMP regulations and other requirements, and is the description of the user's specific requirements to the system or equipment output. It is also the design basis of the system or equipment, determining the performance, and constituting the basis for the acceptance standards. A well written URS can provide enterprises a good foundation for subsequent GMP activities, and finally help improving the efficiency and reducing costs.
However, how to write a proper URS is a challenge faced by many enterprises. The common problems are: either it is over detailed and covers lots of unnecessary technical information, easily causing deviations in the later qualification phase and interrupting the project progress, or it is totally opposite, too brief and lacks necessary and key requirements, resulting in the output system being unable to achieve the intended use and insufficient later qualification work.
URS is a document, belonging to and usually written by an enterprise according to its needs. gempex can assist enterprises to collect, organize, improve, and provide guidance and suggestions for a URS, supporting them to fully understand the proper management strategy and the key points and main contents. All these provides foundation for guiding further activities, including qualification and validation.
Flexible URS strategy, covering all aspects of enterprise requirements while not causing burden for qualification and validation
Clear and specific URS contents, promoting a smoothing running project in cost-effective way
Deep understanding of industry difficulties, efficient support for pharmaceutical factories and equipment suppliers
For this type of the URS, the main purpose is to comprehensively collect the needs of management at all levels for a new project and avoid any omissions. The output can support a design party or institute in a greatextent to conduct a comprehensive plant design. The content commonly covers description of:
For this type of URS specific to a system or equipment, attention is paid to the GMP requirements, functions, materials, key process parameters, data management, document requirements and other aspects according to the system or equipment.
This kind of URS provides a basis for the design and procurement of specific systems or equipment, and can guide qualification and validation activities in the late stage. Therefore, the requirements written in the URS must be clear, quantifiable, and according to the demand. Users need to set the items from the perspective of product and process requirements, mainly considering GMP requirements and high-level process requirements and avoiding list the commercial and detailed designs in URS.
