TEMPLATE FOR USER REQUIREMENT SPECIFICATIONS QUALIFICATION

by

TEMPLATE FOR USER REQUIREMENT SPECIFICATIONS

S. No.

Table of Contents

Page No
1 General
2 Salient Features
3 Operational Requirements
5 Maintenance
6 Inspection and Testing
7 Commissioning and Documentation
8 Training
9 Packaging
10 Deviations
11 Delivery

TEMPLATE FOR USER REQUIREMENT SPECIFICATIONS QUALIFICATION

 TECHNICAL

 

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

 Specification as per Requirement

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

  

 

(These parameters are filled if applicable.)

 

 

 

 

 

 

 

 

 

 

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 M/s Pharmaceutical Company 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 Pharmaceutical 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
10.

Deviations

 Any deviation from URS shall be highlighted
11. Delivery

 

 

  As per purchase order. To be delivered at

Company Address

 

 

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