URS Format

Hi all,

just wondering if there is a format for URS , we want to purchase some euipments for new plant and need to make URS for them. Please tell me how to make this ?

Thanks all,


there is no such format for URS. its user defined and varies. Only thing you have to ensure that all the requirements are covered in the URS for which the vendor requires data to propose an equipment which meets your requirements besides the environmental conditions and utilities available.
You can include say
Purpose, Scope, Reason for URS, Abbreviations, Features Required ( inlcuding operational., alarm etc), Environmental conditions of your facility, Utilities (air, water), power like say 2phase etc etc

Hi Jack (no pun intended)

The URS is one of the most important documents in validation. Not properly specifying what you want is cited by the FDA as one of the major problems in validation.

Their definition of validation; is the verification that all the specified user requirements are fully satisfied.

Hence if you do not specify everything; your validation is going to be flawed.

Alex Kennedy

Please see


For some of the sample URS templates developed by the GAMP Americas JETT Significant Interest Group

Following may be the contents of user requirement specifications but not limited to…

Application, Capacity, structural & Operational Requirements, Safety requirements like earthing, guarding, sound /noise etc, Design features may include electro magnetic interference,radio wavelength interference etc, Environment Requirements, Utility requirements, Cleaning requirements, Sterilization requirements, Instruments and their accuracy requirements, Documentation requirements, Validation requirements, Support from supplier, Testing, Delivery, Engineering Standards or Regulatory standards as applicable
These are typical requirements which shall be the part of URS.
Ravi Dhanbhar