PHARMA DEVILS

IT DEPARTMENT

USER REQUIREMENT SPECIFICATION

Name of Item: Computer System Protocol No.:.........................
Functional Area: IT Page No.: 1 of 13

Instrument Name Computer System

System ID. .................

System Used For High Pressure Liquid Chromatography

Make Waters

HPLC ID. ..................

Application Software Type Chromatographic  Non Chromatographic 

Application Software Empower

Software Version 3.0

Make Waters

System Type New System  Existing system 

Location Instrument Room – I

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IT DEPARTMENT

USER REQUIREMENT SPECIFICATION

Name of Item: Computer System Protocol No.:.........................
Functional Area: IT Page No.: 2 of 13
1.0 CONTENTS:

1.0 CONTENTS ......................................................................................................................... 2

2.0 OBJECTIVE: ........................................................................................................................ 3

3.0 SCOPE: ................................................................................................................................ 3

4.0 RESPONSIBILITIES: .......................................................................................................... 3

5.0 REFERENCES: .................................................................................................................... 4

6.0 SYSTEM OVERVIEW:........................................................................................................ 4

7.0 CONFIGURATION:............................................................................................................. 5

8.0 TECHNICAL REQUIREMENTS: ........................................................................................ 6

9.0 OPERATIONAL/FUNCTIONAL REQUIREMENTS .......................................................... 8

10.0 DATA REQUIREMENTS: ................................................................................................... 9

11.0 CONSTRAINTS: ................................................................................................................ 10

12.0 LIFE CYCLE REQUIREMENTS: ...................................................................................... 10

13.0 ABBREVIATIONS: ........................................................................................................... 11

14.0 APPROVAL PAGE ............................................................................................................ 13

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IT DEPARTMENT

USER REQUIREMENT SPECIFICATION

Name of Item: Computer System Protocol No.:.........................
Functional Area: IT Page No.: 3 of 13

3.0 OBJECTIVE:
This document is prepared to provide user requirement specification for the system from a user,
functional, and technical perspective. It includes the business, system, data, performance, configuration,
environmental/operational, security and audit trail capabilities that the system shall provide to meet the
business needs of the users in the QC Lab at Site.

4.0 SCOPE:
This Document is limited to Computer System and installed Application Software for HPLC in QC Lab
at Site.
This Document is Applicable to Workstation and Applicable Software which covers the following
requirements.
 Configuration Requirements
 Technical Requirements
 Operational / Functional Requirements
 Data Requirements
 Lifecycle Requirements

5.0 RESPONSIBILITIES:
The validation group comprising of the representative from each of the following departments shall be
responsible for overall compliance with the validation plan.
Role Responsibility

Validation Agency  To prepare user requirement specification.

System owner, IT (Site)  To provide necessary documents / support required for user
requirement specification.
 To help in preparation for user requirement specification.
 To review user requirement specification.
QA (Site)  To provide necessary support required for user requirement
specification.
 To review user requirement specification.
QA Head (Site)  To approve user requirement specification.
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IT DEPARTMENT

USER REQUIREMENT SPECIFICATION

Name of Item: Computer System Protocol No.:.........................
Functional Area: IT Page No.: 4 of 13
6.0 REFERENCES:
Document Description

Code of Federal Regulations : Electronic Records; Electronic

CFR Title 21, Part 11
Signatures.
Good Manufacturing Practice; Medical Products for Human and
EU GMP Annexure 11 Veterinary use,Annex 11; Computerized Systems; Volume 4

GAMP5 A Risk – Based Approach to Compliant GxP Computerized

Systems(Good Automated Manufacturing Practices Version 5.0)

7.0 SYSTEM OVERVIEW:

The System used for HPLC (High Pressure Liquid Chromatography) consists of Computer System
Workstation with operating system and Installed Application Software this includes the following:
 Installed Hardware and Operating System Software Configuration.
 Application Software Installation and Configuration.
 Administration and User Access Controls and Configuration for Workstation and
Application Software.
 Operational And Functional Requirements of Workstation and Application Software.
 Interface Between Third Party Software and Hardware.
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IT DEPARTMENT

USER REQUIREMENT SPECIFICATION

Name of Item: Computer System Protocol No.:.........................
Functional Area: IT Page No.: 5 of 13
8.0 CONFIGURATION:
7.1 System security

Req. No. Requirement Description

7.1.1 The System/ Software should provide the facility to creation of new user account.

7.1.2 The Software should not allow to create duplicate user account.

7.1.3 The Software should provide the facility to Modification in user account.

The System/ Software should not allow user to login without correct combination of
7.1.4
User Name/ ID and Password.

7.1.5 The System/ Software must mask password entry.

7.1.6 The System/ Software should allow administrator to reset user account.

7.1.7 The System/ Software should provide the facility to Disable/ Remove user accounts.

7.1.8 The System/ Software should be locked after pre-defined time.

7.1.9 The Software should configured to define the password age.

7.1.10 The Software should configured to define minimum password length

7.1.11 The Software should configured to define complexity requirement.

7.1.12 The Software should configured to define auto lockout duration

7.1.13 The Software should configured to define invalid login attempts

7.1.14 The Software should configured to change own password.

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IT DEPARTMENT

USER REQUIREMENT SPECIFICATION

Name of Item: Computer System Protocol No.:.........................
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7.2 User Role / Authorization Control Requirements:
7.2.1 Application Software:

Req. No. Requirement Description

The Application software must support at least the following user roles but not limited
to:
7.2.1.1 1. Analyst
2. Reviewer
3. Administrator
Access to the system function shall be control based on user roles and privileges.
7.2.1.2
Privileges should be verified with respect to SOP.

8.0 TECHNICAL REQUIREMENTS:

8.1 HARDWARE REQUIREMENTS:
8.1.1 Workstation Specification:

Req. No. Description Minimum Requirement

8.1.1.1 Make Any Reputed
8.1.1.2 Model As specified
8.1.1.3 Processor As specified
8.1.1.4 RAM As specified
8.1.1.5 Capacity of HDD As specified
8.1.1.6 Operating System As specified
8.1.1.7 License of OS Should be Available

8.2 Software Requirements:

Req. Description Software Specification

No.
Application Software
8.2.1 Software Name Empower

8.2.2 Version Version 3.0

8.2.3 License Should be Available
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USER REQUIREMENT SPECIFICATION

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8.3 Environmental Condition:

The Environmental Condition for Workstation should be in specified range as follows:

Req. No. Description Specified Requirement

8.3.1 Operating temperature (˚C) Below 30℃
8.3.2 Operating Relative humidity (%) Below 60%

8.4 Electrical Supplies:

The electrical supply requirements for the configuration hardware system should be within
specified as follows:

Req. No. Description UPS Specification

8.4.1 UPS UPS should be available
110-240 VAC or as per system
8.4.2 Power Supply
recommendation

8.5 Communication/Power Failure And Recovery:

Req. No. Requirement Description

8.5.1 Communication failure indication should be displayed in the software.

After reestablishing the communication, the set parameters / process activity should
8.5.2
remain unchanged. OR No any error message shall display.
8.5.3 In case of power failure, system should be normally start after power resume

8.5.4 In case of power failure; Method Parameters / sequence should not be affected.
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IT DEPARTMENT

USER REQUIREMENT SPECIFICATION

Name of Item: Computer System Protocol No.:.........................
Functional Area: IT Page No.: 8 of 13
9.0 OPERATIONAL/FUNCTIONAL REQUIREMENTS
9.1 Operational Requirements:

Req. No. Requirement Description

9.1.1  The software should be controlled by username and password.

 The software should allow user to fill the required details to start the sample.
 The Software should allow user to view analysis result on the display.
9.1.2  The Software should allow user to view report of generated data.
 The Software should allow user to print the report in predefined format.
 The software should generate data/report in unalterable way.

9.2 Functional Requirements:

Req. No. Requirement Description

9.2.1  Software should allow authorized personnel to access the existing records.
9.2.2  E-records should not be deleted by users.
9.2.3  Report templates should not be editable by unauthorized users.
 The Software shall not allow to manipulate/ change any parameter in existing
9.2.4
Batch/ Project.

9.3 Report Output Requirements:

Req. No. Requirement Description

 Printed report from software should be match with displayed in application
9.3.1
software.
 Report must have the following parameters but not limited to:
 Test Info
9.3.2
 Sample Info
 Results Data
9.3.3  The software should generate data/report in unalterable way.
9.3.4  Report should be printable in pre-defined format.
 The software shall be capable to producing accurate and complete copies of
9.3.5 electronic records in both human readable and electronic form for inspection,
review and copy.
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IT DEPARTMENT

USER REQUIREMENT SPECIFICATION

Name of Item: Computer System Protocol No.:.........................
Functional Area: IT Page No.: 9 of 13
10.0 DATA REQUIREMENTS:
10.1 Audit Trail Requirements:
10.1.1 Application Software:
Audit trail shall be generated as per requirements outlined below:

Req. No. Requirement Description

The system audit trail must track the creation, modification, and deletion of records,
Including the time, date, person, and reason for the change. E.g.
 User login/ logout.
10.1.1.1
 Change in parameters.
 Incorrect login attempts
 Change in user authorization of application software
The audit trail must be viewable, and can be exported in protected non-editable
10.1.1.2
format.
10.1.1.3 The audit trail must be protected from intentional or accidental modification.
10.1.1.4 It must not be possible to modify or delete audit reports / audit trails.
10.1.1.5 Generated Audit Trail should be printable. Print should be in human readable format.

10.2 Data Backup Requirements:

Req. No. Requirement Description

10.2.1 All GxP Critical data should be backup as per procedure.
10.2.2 Data Backup mechanism should be available.
10.2.3 Backup schedule should be available

10.3 Data Restoration Requirements:

Req. No. Requirement Description

10.3.1 Data restoration policy should be define as per the procedure.
10.3.2 Data restoration mechanism should be available.

10.4 Data Migration Requirements:

NA
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IT DEPARTMENT

USER REQUIREMENT SPECIFICATION

Name of Item: Computer System Protocol No.:.........................
Functional Area: IT Page No.: 10 of 13
11.0 CONSTRAINTS:
11.1 Compatibility:
The URS document primarily covers the requirements of Workstation/ Software and related services
(e.g. OS, Equipment, Instrument, Power requirements etc.) While the compatibility may not be a
major constraint, the following points should be addressed during design and installation:
 Operating system and application software.
 Third party interfaces
 Compatibility of Application Software with Devices which captures Data (e.g.
Instruments, Equipment, Data Entry terminals)
11.2 Availability:
The System data flow requirements high availability of the system due to its critical nature
following points should be addressed during design and installation:
 Workstation hardware
 Network
 Reference documentation
 Service provider support
 Trained Man power for operation and maintenance.
 Application backup with configuration
 Data backup
11.3 Reliability:
The system is being installed should be treated as highly critical due to its novelty and
complexity. following points should be addressed during design and installation:
 Design review by Subject Matter Experts for end to end data flow
 Supplier Qualification
 Training records of development engineers
 Comprehensive risk assessment

12.0 LIFE CYCLE REQUIREMENTS:

12.1 Documentation Requirements:

Req. No. Description

12.1.1 Software Manual
12.1.2 Vendor documents
12.1.3 Application Software License Copy/ Media
12.1.4 Training Records

12.2 Standard Operating Procedures:

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IT DEPARTMENT

USER REQUIREMENT SPECIFICATION

Name of Item: Computer System Protocol No.:.........................
Functional Area: IT Page No.: 11 of 13

Req. No. Description

12.2.1 SOP for Computer System Operation

12.2.2 SOP for Change Control

12.2.3 SOP for Access Control

12.2.4 SOP for User Creation/Deletion/ Role and Authorization.

12.2.5 SOP for Preventive Maintenance

12.2.6 SOP for Data Backup and Restoration

12.2.7 SOP for Disaster recovery Plan and Policy

12.2.8 SOP for Group Desktop and Security Policy

12.2.9 SOP For Training and Evaluation

13.0 ABBREVIATIONS:
Abbreviation Full form
AAT Validation Agency
CSV Computerized System Validation
QM Quality Management
QC Quality Control
QA Quality Assurance
Generic acronym for pharmaceutical regulations, Good Manufacturing
GxP Practice (GMP), Good Laboratory Practice (GLP) & Good Clinical Practice
(GCP)
URS User Requirement Specification
GAMP Good Automated Manufacturing Practices
GMP Good Manufacturing Practices
mA Milli Ampere
EU European Union
IT Information Technology
LAN Local Area Network
NA / N/A Not Applicable
No. Number
QA Quality Assurance
Ref. Reference
QC Quality Control
Req. Requirement
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USER REQUIREMENT SPECIFICATION

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Abbreviation Full form
SOP Standard Operating Procedure
Sr. Serial
UPS Uninterrupted Power Supply
USFDA United States Food and Drug Administration
Y/N Yes/ No
GB Gigabytes
GHz Giga Hertz
CAT Category
VAC Voltage - Alternating Current
RH Relative humidity
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USER REQUIREMENT SPECIFICATION

Name of Item: Computer System Protocol No.:.........................
Functional Area: IT Page No.: 13 of 13
14.0 APPROVAL PAGE

Department Name Designation Signature Date

Prepared by: M/s. ..................

ENGINEERING

Reviewed by: M/s. ..................

QUALITY
ASSURANCE
Reviewed by: M/s. ..................

ENGINEERING

Reviewed by: M/s. ..................

IT DEPARTMENT

Reviewed by: M/s. ...................

QUALITY
CONTROL

Approved by: M/s. ...................

QUALITY
ASSURANCE