Template for User Requirement Specification (URS)

Tamplate for User Requirement Specification

TECHNICAL Specifications

S. No. Parameters Required Specifications
1.

1.1

1.2

1.3

1.4

1.5

 General

Equipment No.

Description

Use

Field Identification

Glossary

 

 

 

 

 

 

2.

2.1

 

2.2

2.3

2.4

Salient Features

General

 

Material of Construction

Finish

Electrical Construction

 

Smooth  Finish/matt finish/mirror finish

Non flameproof / flameproof

 

3.

3.1

 3.2 

3.3

3.4

3.4.1

3.4.2

 

 

3.4.3

 

3.4.4

3.4.5

3.5

3.6

3.7

 

3.8

 

 

 

 

3.9

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.

4. 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.
5. 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

6. Inspection and Testing
 

7.

 

 

7.1

 

Commissioning and Documentation

 

Development

· 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.

The Supplier shall provide a Project Manager for the project to provide a single communication point with the User.

8.

 

8.1

8.2

Training

 

Start up support

Post start up support

Supplier to train the respective technical associates of pharma company on operation, maintenance and cleaning of the equipment wherever applicable.

Telephone / Fax / E mail ID / Address

Replacement parts availability list (normal lead times shall be listed)

System improvements (supplier shall notify user of any improvements)

9.

 

Packaging  Supplier to specify packaging of machine for safe transportation and delivery at the site.
10. Deviations Any deviation from URS shall be highlighted
11. Delivery As per purchase order. To be delivered at :

 

 

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