User Requirement Specifications
User Requirement Specifications
¨ User
Requirement Specifications (URS): User requirements specifications is a
complete list of the necessities from the user, that is provided to the
manufacturer to get the desired material that fall within the acceptable
criteria.
¨ User
requirements specifications are prepared for system, equipment and utilities
where applicable.
¨ Verification
of URS is required at later stage to confirm that is the purchased or supplied
system, utility or equipment is fall within the criteria that is required for
the intended purpose and the specifications given by the supplier .
¨ Providing
URS to the manufacturer following points should be considered.
¨ Introduction:
Instrument, equipment & system should be properly introduced in written
form.
¨ Purpose:
Purpose for which the instrument, equipment & system is to be installed
should be briefly defined.
¨ Scope:
Scope of the instrument, equipment or system will be write down.
¨ Safety:
Safety protocols will be explained briefly.
¨ Abbreviations:
Abbreviations used will be written.
¨ References:
References of the compendial books or guidelines will be provided in
written.
¨ Overview:
This section will include following aspects
¨ Intended
Use: Use of the equipment, instrument or system in the manufacturing.
¨ Location:
Location where equipment, instrument or system to be installed.
¨ Other
areas of impact: Specify other areas that are to be impacted.
¨ Capacity:
Capacity of instrument, equipment
or system should be defined.
¨ Construction
material: Details of the material that is used in construction like metal, SS
etc
¨ Accuracy:
Accuracy of the instrument, equipment or system should be defined.
¨ Calibration:
Write down is calibration requirements.
¨ Cleaning
requirements & Schedule: Cleaning requirements and schedule should be
explained briefly.
¨ Utility:
Write down utility requirements.
¨ Operation
procedure: Operation procedure should be provided here.
¨ Approval:
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