TEMPLATE FOR USER REQUIREMENT SPECIFICATIONS
Table of Contents
General
Salient Features
Operational Requirements
Maintenance
Inspection and Testing
Commissioning and Documentation
Training
Packaging
Deviations
Delivery
TECHNICAL
General – Equipment No. ,Description
Use – Field Identification ,Glossary
Salient Features
General – Specification as per Requirement Smooth Finish/matt finish/mirror finish Non flameproof / flameproof
Material of Construction
Finish
Electrical Construction
Operational requirements
Capacity
Control Parameter
Desired Accuracy
Control
Data & Security
User interface with supervisors and operators for the control platform
Interface with other equipments and system
Security level
Data collection
Component Reference details
Functional Requirements
Alarm System
Power failure / recovery
Emergency stop
Preferably the sound alarms / beep shall be provided along with light indication
In the event of a power failure, the system shall protect product against damage. The system will stop in a safe mode automatically upon loss of electricity, air or other major utility and will require operator intervention to re-start.
The emergency stop mechanism(s) shall be provided.
Utilities :To provide utilities at ONE POINT is user’s responsibility. Supplier to give details and drawings for exact size, location, type, capacity etc. of the utilities required.
Maintenance :
Supplier should provide the following maintenance instructions,
i. Operation and Maintenance manuals along with as built drawings
ii. Lubrication instructions
iii. Daily checks on machine
Cleaning procedures
Inspection and Testing
Commissioning and Documentation :IQ/OQ/PQ to be completed by the supplier along with M/s Pharmaceutical Company representatives.
Development :The Supplier to demonstrate the Performance of the machine at User site as per agreed terms.
The Supplier shall provide a Project Manager for the project to provide a single communication point with the User.
Training :
Supplier to train the respective technical associates of Pharmaceutical Company on operation, maintenance and cleaning of the equipment wherever applicable.
Start up support :
Telephone / Fax / E mail ID / Address
Replacement parts availability list (normal lead times shall be listed)
Post start up support :
System improvements (supplier shall notify user of any improvements)
Packaging
Deviations :Any deviation from URS shall be highlighted
Delivery :As per purchase order. To be delivered at Company Address
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