User Requirements Specification.

The User Requirements Specification defines the requirement for the equipment and the function of the equipment in the production, testing, storing and or handling of company product that is the subject of regulatory compliance rules and regulations. The use of this URS will ensure that the equipment is specified, purchased, installed, operated and maintained in accordance with the Company Quality Standards and the cGMP requirements as defined in the United States Code of Federal Regulations, Title 21, Parts 820, 210, 211 & 11, and the European Union – Good Manufacturing Practice Directive 91 / 356 / EEC, (EU-GMP).

The document that sets the standard, and specifies your requirements in a manner that ensures when a system or piece of equipment is selected, it will deliver the functions you want, it will have maintenance standards, it will have calibration records, it will have all the documents and records to enable successful validation to be completed. This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the URS through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems that are the subject of predicate rules. It can be used on mechanical, electrical and software controlled, monitored or driven systems.

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