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URS & FDS documentation
The intention of the User Requirement Specification (URS) and the Function Design Specification (FDS) is to retrieve as much relevant information as possible for the construction of a chromatography system.
User Requirements Specification (URS)
The User Requirements Specification specifies the user's expectations and requirements. The URS document contains information relating mainly to the chromatography method(s) to be used and describes the intended use of the system. The focus is on production methods, volumes, purity of the final product, security required and other areas regarding user requirements. The URS will serve as a basis for the Functional Design Specification (FDS). The URS can be completed by the pharmaceutical producer.
Functional Design Specification (FDS)
The purpose of the Functional Design Specification is to provide the system supplier (or suppliers) with the necessary information to make a detailed provisional design plan for the system (specified in the System Quotation). All system components and connections are described in detail.
It is recommended that both the pharmaceutical producer and the system supplier work together to provide the requested information for the FDS document, or that the document is reviewed/discussed with the supplier before approval. The system supplier can/will contribute with technical knowledge, experience and other items of interest for the design, construction and operation of the system.
The URS and FDS document templates are free of charge and are supplied as hard copy in a single binder and as a form-protected Microsoft™ Word file on a CD-ROM. Contact your local GE Healthcare Sales Representative for more details. |
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