User Requirement Specification (URS) in Pharma + Template

User Requirements Specification (URS),

An authorized document that defines the requirements for use of the system, equipment or utility in its intended production environment.

The User Requirements Specification document contains requirements from multidisciplinary sources and supports design, commissioning and qualification activities, operations, and maintenance.

URS documentation should be prepared for, but not limited to, utilities and equipment, as appropriate.

URS should be used at later stages in qualification, to verify that the purchased and supplied utility or equipment is in accordance with the user’s needs.

For the Preparation of URS,

• Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) are key inputs into user requirements specifications which are required to support the Quality Risk Management based Commissioning and Qualification process and are identified prior to User Requirement Specification generation.
• User requirements specifications documents can be written around a platform to address the requirements of a multi-purpose operation.
• User requirements specifications are living documents that are updated as requirements change during any phase of a project or as additional risk controls are identified.
• The user requirements specification document should not contain the content of engineering specifications and standards, the means by which user requirements are met, or contain contractual contract requirements.

User shall define their requirements in this document (URS) by considering the following points, (Not limited to);

Requirement from vendor,

• Packing and Transportation
• Quality Agreement
• Documentations e.g. Design Qualification (DQ), Factory Acceptance Test (FAT), Installation Qualification (IQ), Operational Qualification(OQ), User Manual / Maintenance Manual, Preventive Maintenance Reomandetion, Spare Part List, Certificate of Bought out items for Calibration, Material of construction (MOC) etc. wherever applicable.
• Support in Factory Acceptance Test (FAT), Installation Qualification (IQ) and Operational Qualification(OQ).
• After Installation Service

Operational Requirement,

• What is the input and what is the output requirement
• Automation or Manual
• Cleanability (wherever applicable.)

Engineering Requirement,

• Functional Specification / Requirement,
• Utility requirements e.g. Electricity, Water, Steam, Light, Compressed Air, Gases (Nitrogen, Oxygen etc.), HVAC, Computer System etc.

Control Strategic Requirement,

• Password protection
• Security Level
• Safety (Operator and Equipment)

Specific Requirement,

• The specific requirement like; if any equipment has interconnectivity with other equipment which may be existing equipment or need to purchase from other vendors

References,

in this section, User shall mention preferable Make and Models which are available in the market and fulfill the user’s requirement

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