Home / Validation & Qualification / Qualification / User Requirement Specification(URS) / TEMPLATE FOR USER REQUIREMENT SPECIFICATIONS

TEMPLATE FOR USER REQUIREMENT SPECIFICATIONS

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

 

 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

 

 

For More Pharma Updates Visit –https://pharmaguidances.com

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

Check Also

USER REQUIREMENT SPECIFICATION OF PRESSURE VESSEL 150 L

USER REQUIREMENT SPECIFICATION OF PRESSURE VESSEL 150 L S. No Table of Contents 1 General …