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Steril-Gene Life Sciences (P) Ltd.

,
Puducherry
Analytical Research and Development
USER REQUIREMENT SPECIFICATION FOR
TITLE
REFRACTIVE INDEX DETECTOR

Approved date
URS No. URS/D-AD/003-02
Page No. 1 of 13

USER REQUIREMENT SPECIFICATION FOR REFRACTIVE INDEX DETECTOR


Steril-Gene Life sciences (P) Ltd.
No.45, Mangalam main road,
Mangalam Village,Villianur Commune,
Puducherry-605110.
Steril-Gene Life Sciences (P) Ltd.,
Puducherry
Analytical Research and Development
USER REQUIREMENT SPECIFICATION FOR
TITLE
REFRACTIVE INDEX DETECTOR

URS No. URS/D-AD/003-02 Page No. 2 of 13

1.0 TABLE OF CONTENTS

S. No. Index Page No.

Cover page 01

1.0 Table of contents 02

2.0 Document approval page 03

3.0 Purpose 04

4.0 Scope 04

5.0 Responsibility 04

6.0 Purpose of the equipment 04

7.0 Equipments requirements 04-05

8.0 User requirement specification 05-06

9.0 Operational requirements 07


07
10.0 Delivery
08
11.0 Abbreviations

12.0 References 08

13.0 Attachment 08

14.0 Revision history 08


Steril-Gene Life Sciences (P) Ltd.,
Puducherry
Analytical Research and Development
USER REQUIREMENT SPECIFICATION FOR
TITLE
REFRACTIVE INDEX DETECTOR

URS No. URS/D-AD/003-02 Page No. 3 of 13

2.0 DOCUMENT APPROVAL PAGE

PROTOCOL APPROVAL

SIGNATUR
RESPONSIBILITY NAME DESIGNATION
E & DATE

Prepared by (AD)

Reviewed by (AD)

Reviewed by (QA)

Approved by (QA)
Steril-Gene Life Sciences (P) Ltd.,
Puducherry
Analytical Research and Development
USER REQUIREMENT SPECIFICATION FOR
TITLE
REFRACTIVE INDEX DETECTOR

URS No. URS/D-AD/003-02 Page No. 4 of 13

3.0 PURPOSE

The purpose of this document is the detail requirement of user requirement


specification (URS) of refractive index detector as per the user and regulatory
prospective. This gives clear understanding about refractive index detector to the
supplier and analytical research and development requirements of instrument at Steril-
Gene Life Sciences (P) Ltd., Puducherry.

4.0 SCOPE

The user requirement specification (URS) is applicable to the proposed refractive index
detector for Steril-Gene Life Sciences (P) Ltd. Puducherry.

5.0 RESPONSIBILITY

Department Responsibilities
Analytical Research and
To prepare and review the URS
Development

Quality assurance To review and approve the URS

6.0 PURPOSE OF THE INSTRUMENT

Refractive index detector plays a crucial role in detecting and quantifying compounds
that lack chromophores or fluorophores of raw materials and drug products

7.0 EQUIPMENT REQUIREMENTS


Refractive index detector shall comprise of the following module
7.1 Physical specification
7.2 Performance specification
Steril-Gene Life Sciences (P) Ltd.,
Puducherry
Analytical Research and Development
USER REQUIREMENT SPECIFICATION FOR
TITLE
REFRACTIVE INDEX DETECTOR

URS No. URS/D-AD/003-02 Page No. 5 of 13

8.0 USER REQUIREMENT SPECIFICATION

REQUIREMENT
URS-ID DESCREPTION/SPECIFICATIONS
S

DESIGN AND ENVIRONMENTAL REQUIREMENTS


System shall be available with standard hardware and
DR-01
software to perform various operations.
DR-02 System shall be stable in ambient environmental
System
condition.shall be connected with Uninterrupted Power
DR-03 Design
Supply.
System settings and set parameters shall remain Requirements
DR-04 unchanged when power & communication failure occurs
and restored.
System shall be connected with dedicated servers for
DR-05
database storage and applications.
Validation shall be performed with validation server and
DR-06 the same configurations extended to the production
servers.
REGULATORY REQUIREMENTS

RR-01 VALIDATION REQUIREMENTS

Functional design specifications.


Software PVP (pre-validated protocols) / validation
documents. User and
Functional, Operational & configurations Risk Regulatory
Assessment.
Electrical drawing/ system network architecture /network Requirements
architecture.
Validation procedures
Steril-Gene Life Sciences (P) Ltd.,
Puducherry
Analytical Research and Development
USER REQUIREMENT SPECIFICATION FOR
TITLE
REFRACTIVE INDEX DETECTOR

URS No. URS/D-AD/003-02 Page No. 6 of 13

REQUIREMENT
URS-ID DESCREPTION/SPECIFICATIONS
S

Operational procedures

Change management procedures

Data backup and restore procedures

Password policy procedures

Disaster management procedure User and

Deviation management Procedure Regulatory


Requirements
RR-02 BUSINESS PROCESS REQUIREMENTS
System shall be available with the graphics screen to
perform various operations. User and
System shall not allow settings of parameter outside the Regulatory
specified range. Requirements
System/business continuity with adequate engineering or
administrative controls.

RR-03 SECURITY REQUIREMENTS

System shall have auto logoff feasibility when system is


in inactive / idle condition. User and
System Users passwords shall have specified character Regulatory
with complexity. Requirements

System shall enforce user to change the password after


specified days.
Steril-Gene Life Sciences (P) Ltd.,
Puducherry
Analytical Research and Development
USER REQUIREMENT SPECIFICATION FOR
TITLE
REFRACTIVE INDEX DETECTOR

URS No. URS/D-AD/003-02 Page No. 7 of 13

REQUIREMENT
URS-ID DESCREPTION/SPECIFICATIONS
S

User’s password shall be masked.


System shall have feasibility to lock/deactivate the user
IDs after specified consecutive unsuccessful login
attempts.
System administrator shall have ability to create a new
user/level.
System administrator shall have ability to edit/modify
user/level.
System administrator shall have ability to Lock/deactivate
user/level.

System must have various access levels (e.g. Operator,


Supervisor, Administrator and Manager).
System shall have unique user ID’s and password
feasibility.

System shall allow users to change their own password.

Systems and servers connected with proper IT network


securities (i.e. firewall, antivirus, domain defenders but
not limited too).

RR-04 REPORTING REQUIREMENTS


System shall generate different types of reports in non- User and
editable format. Regulatory
System shall have facility to generate audit trail report Requirements
with necessary details.
Steril-Gene Life Sciences (P) Ltd.,
Puducherry
Analytical Research and Development
USER REQUIREMENT SPECIFICATION FOR
TITLE
REFRACTIVE INDEX DETECTOR

URS No. URS/D-AD/003-02 Page No. 8 of 13

REQUIREMENT
URS-ID DESCREPTION/SPECIFICATIONS
S

Printer shall be connected to system for reports printing.

RR-05 INTERFACE REQUIREMENTS


System shall have proper communication between
network components.
System shall have proper communication between the
clients and network connected computers. User and
System shall display the message when communication
Regulatory
failure occurred and system shall work normal when
Requirements
communication failure is restored.
After restoring power and communication, the server
application and database shall be auto-synchronize.
ELECTRONIC RECORDS & ELECTRONIC SIGNATURES
RR-06
REQUIREMENTS
Electronic records & Electronic signature shall be
available only in non-editable format. Electronic records
and electronic signatures must define the date, time, User and
operations performed and name of the person who Regulatory
performed the activity. Requirements
System shall generate full copies of electronic records
and their audit trail report in human readable form.
System shall prevent users from changing or deleting
audit trail report entries.
Steril-Gene Life Sciences (P) Ltd.,
Puducherry
Analytical Research and Development
USER REQUIREMENT SPECIFICATION FOR
TITLE
REFRACTIVE INDEX DETECTOR

URS No. URS/D-AD/003-02 Page No. 9 of 13

REQUIREMENT
URS-ID DESCREPTION/SPECIFICATIONS
S
As per below requirements the E-sign shall be considered
legally valid,
Adopted by the signer with the intent to sign the
document.
Attached to or logically associated with the document.

Unique to the signer and able to verified.

Time stamped and audit trails shall be available.

If not meet the above requirements of E- sign, the user


credentials shall read as E-sign but it shall not be consider
legally valid.

RR-08 DATA BACKUP REQUIREMENTS


System shall have provision to take data backup and data
User and
restoration.
Regulatory
System shall have permission only for authorized users to
Requirement
take data backup and data restoration.

SERVICE REQUIREMENTS
Software and service Agreements like AMC,QTA,SLA
SR-01
but not limited too
Service
SR-02 Software release notes.
Requirements
Software and service manuals like operational manual,
SR-03
user manual, data sheets but not limited too
Steril-Gene Life Sciences (P) Ltd.,
Puducherry
Analytical Research and Development
USER REQUIREMENT SPECIFICATION FOR
TITLE
REFRACTIVE INDEX DETECTOR

URS No. URS/D-AD/003-02 Page No. 10 of 13

9.0 OPERATIONAL REQUIREMENTS


DESCREPTION/
URS-ID REQUIREMENTS
SPECIFICATIONS
PHYSICAL SPECIFICATION

OR-01 Weight 15 kg (33 lbs)


Dimensions 180 x 396 x 436 mm
(height × width × depth) (7.1 x 15.6 x 17.2 inches)
Line voltage 100 – 240 V~, ± 10 %
Line frequency 50 or 60 Hz, ± 5 %
Power consumption 80 VA / 70 W
Ambient operating
4–55 °C (39–131 °F)
temperature
Ambient non-operating
-40 – 70 °C (-40 – 158 °F)
temperature
Humidity < 95 % r.h. at 40 °C (104 °F)
Operating altitude Up to 3000 m (9842 ft)

Non-operating altitude Up to 4600 m (15092 ft)

Safety standards: IEC,


Installation category II, Pollution degree 2
EN, CSA, UL
ISM Classification ISM Group 1 Class B

PERFORMANCE SPECIFICATION

OR-02 Detection type Refractive Index


Refractive index range 1.00 – 1.75 RIU, calibrated
Measurement range ±600·10-6 RIU
Steril-Gene Life Sciences (P) Ltd.,
Puducherry
Analytical Research and Development
USER REQUIREMENT SPECIFICATION FOR
TITLE
REFRACTIVE INDEX DETECTOR

URS No. URS/D-AD/003-02 Page No. 11 of 13

DESCREPTION/
URS-ID REQUIREMENTS
SPECIFICATIONS
Optical zeroing via set screw
Optics temperature
5 °C above ambient to 55 °C
control
Volume: 8 µL Maximum pressure: 5 bar (0.5 MPa)
Sample cell
Maximum flow rate: 5 mL/min
Valves Automatic purge and automatic solvent recycle
Inlet port to sample cell 62 µL,
Volumes
inlet port to outlet port 590 µL
Liquid contact materials 316 stainless steel, PTFE and quartz glass
pH range 2.3 – 9.5
Performance Short term noise: <±1.25·10-9 RIU
specifications Drift: <200·10-9 RIU/hr
Time programmable
polarity, peak width
parameters
Maximum data rate 74 Hz
Detector zero automatic zero before analysis
Lab Advisor B.02.07 or above
Instrument Control
LC and CE Drivers A.02.12 or above
Local control Agilent Instant Pilot (G4208A)
Recorder/integrator: 100 mV or 1 V,
Analog outputs
output range selectable, one output
LAN, controller-area network (CAN), ERI: ready,
Communications
start, stop and shut-down signals
Steril-Gene Life Sciences (P) Ltd.,
Puducherry
Analytical Research and Development
USER REQUIREMENT SPECIFICATION FOR
TITLE
REFRACTIVE INDEX DETECTOR

URS No. URS/D-AD/003-02 Page No. 12 of 13

DESCREPTION/
URS-ID REQUIREMENTS
SPECIFICATIONS
Extensive diagnostics, error detection and display,
leak detection, safe leak handling, leak output signal
Safety and maintenance
for shutdown of pumping system. Low voltages in
major maintenance areas.
Early maintenance feedback (EMF) for continuous
tracking of instrument usage with user-selectable
GLP features limits and feedback messages. Electronic records of
maintenance and errors. Automated operational
qualification/performance verification (OQ/PV).
Housing All materials recyclable.

10.0 DELIVERY
To be delivered at the following site address,
Steril-Gene Life Sciences (P) Ltd.,
No.45, Mangalam main road,
Mangalam village, Villianur Commune,
Puducherry- 605 110

11.0 ABBREVIATIONS

S. No. Acronym Definition


1. AD Analytical research and development
2. URS User requirement specification
3. RID Refractive Index Detector
4. IQ Instrument Qualification
5. OQ Operation Qualification
Steril-Gene Life Sciences (P) Ltd.,
Puducherry
Analytical Research and Development
USER REQUIREMENT SPECIFICATION FOR
TITLE
REFRACTIVE INDEX DETECTOR

URS No. URS/D-AD/003-02 Page No. 13 of 13

S. No. Acronym Definition


6. QA Quality Assurance
7. (P) Private
8. Ltd. Limited

12.0 REFERENCES
12.1 Standard Operating Procedure “Equipment Qualification” QA/124
12.2 EU Annexure 11.
12.3 21 CFR part 11 and sub parts.

13.0 ATTACHMENT
13.1 Specification of Agilent 1260 Infinity II Refractive Index Detector (G7162A).

14.0 REVISION HISTORY

S.No. Approved date Version Reason for changes

01 01 New URS

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