Template for User Requirement Specification
TECHNICAL SPECIFICATION
General
- Equipment No.
- Description
- Use
- Field Identification
- Glossary
Salient Features
- General
- Material of Construction
- Finish – Smooth Finish/matt finish/mirror finish
- Electrical Construction – Non flameproof / flameproof
Operational requirements
Capacity
Control Parameter
Desired Accuracy
Control
Data & Security
User interface with supervisors and operators for the control platform
Interface with other equipment’s and system
Security level
Data collection
Component Reference details
Functional Requirements
Alarm System – Preferably the sound alarms / beep shall be provided along with light indication
Power failure / recovery –
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.
Emergency stop – 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 representatives.
The Supplier to demonstrate the Performance of the machine at User site as per agreed terms.
Development –
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 pharma company on operation, maintenance and cleaning of the equipment wherever applicable.
Start up support –Telephone / Fax / E mail ID / Address
Post start up support –
Replacement parts availability list (normal lead times shall be listed)
System improvements (supplier shall notify user of any improvements)
Packaging – Supplier to specify packaging of machine for safe transportation and delivery at the site.
Deviations – Any deviation from URS shall be highlighted.
Delivery -As per purchase order.