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INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

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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

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1.0 DOCUMENT PRE-APPROVAL:

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. ................

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QUALITY ASSURANCE

TABLE OF CONTENTS

1.0 DOCUMENT PRE-APPROVAL:......................................................................................... 2

2.0 TABLE OF CONTENTS: ..................................................................................................... 3

3.0 PURPOSE: ............................................................................................................................. 4

4.0 SCOPE: .................................................................................................................................. 4

5.0 DESCRIPTION: .................................................................................................................... 4

6.0 REFERENCES: ..................................................................................................................... 4

7.0 RESPONSIBILITIES: ........................................................................................................... 5

8.0 DEFINITIONS: ..................................................................................................................... 5

9.0 EXECUTION INSTRUCTIONS: ........................................................................................ 7

10.0 INSTALLATION QUALIFICATION: ................................................................................ 8

11.0 RECORDED VERIFICATIONS DURING INSTALLATION QUALIFICATION: ....... 11

12.0 COMPUTER SYSTEM VALIDATION (Hardware and Software) ................................. 16

13.0 DISCREPANCY REPORT: ................................................................................................ 17

14.0 ACCEPTANCE CRITERIA: .............................................................................................. 20

15.0 SUMMARY: ........................................................................................................................ 21

16.0 CONCLUSION: ................................................................................................................... 21

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17.0 ABBREVIATIONS: ............................................................................................................ 21

18.0 LIST OF SUPPORTING DOCUMENTS:.......................................................................... 23

19.0 DOCUMENT POST APPROVAL:..................................................................................... 24

2.0 PURPOSE:
This document covers the Installation Qualification for the Computer System (Hardware and
Software) installed. The purpose of this document is to properly document and evidence that the
Instrument installation (Computer System and installed Software) has been done in accordance
with the given specifications and is operating as desired.

3.0 SCOPE:
Scope of this document is to record and report the execution of IQ of the computer systems and
Software as per there operations in Quality Control, Production and Documentation.

4.0 DESCRIPTION:
The Installation Qualification (IQ) execution; verifies that the Instrument, and its ancillary
systems or Sub-Systems have been installed in accordance with installation drawings and
specifications. It further details a list of all the cGMP requirements that are applicable to this
particular installation qualification. These requirements must be all satisfied before the IQ can be
completed and the qualification process is allowed to progress to the execution of OQ.
The Installation and Operational qualification (IOQ) is a collection of test cases used to verify the
proper functioning status of a system. IOQ is majorly performed in case of:

a. New Installation (When there is fresh installation of Hardware/Software or both)

b. Existing system (When Hardware/ Software is already Installed And running properly)
c. Change in Location of the system (When Hardware is shifted from initially installed
location to new location according to approved change control procedure.

NOTE: This Document covers the reports of IQ for Existing System.

5.0 REFERENCES:
a. Good Automated Manufacturing Practices (GAMP)-5 Guidelines (This guideline is the
latest, upto date thinking in the approach to validation of GxP computerized system.
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b. EU GMP Annexure-11( Annex. -11 is part of European GMP Guidelines and defines the
terms of references for computerized systems used by the organizations in the
pharmaceutical industry.
c. 21 CFR Part 11 (Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal
Regulations that establishes the United States Food and Drug Administration (FDA)
regulations on electronic records and electronic signatures (ERSE).
d. Who Guidelines on Validation- Appendix 5 Validation of Computerized Systems.

6.0 RESPONSIBILITIES:
Department Responsibility
Engineering, Information
Review of IQ Document. Verification of IQ test. Provide support required
Technology, Quality Control.
during operational qualification.

Quality Assurance Review and approval of IQ document. Verification of IQ tests.

Consultant Prepare IQ Document and Performing IQ tests as per IQ Document.

7.0 DEFINITIONS:

Term Definition
Actual Result What a system does when a particular action is performed
Deliverable A tangible or intangible object produced as a result of project execution, as part of an
obligation. In validation projects, deliverables are usually documents.
Deviation When a system does not act as expected
End-User A person who uses the validated system
Expected Result What a system should do when a particular action is performed
Installation Establishing confidence that process Instrument and ancillary systems are compliant with
appropriate codes and approved design intentions, and that manufacturer
Qualification recommendations are suitably considered. In practice, the installation qualification is
the executed test protocol documenting that a system has the necessary prerequisite
conditions to function as expected.
Protocol A collection of Test Cases, used to document the testing of a system.
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Term Definition
Qualification A testing protocol which designates that a system meets a particular collection of
requirements. An Installation Qualification ensures that a system has been properly
installed. An Operational Qualification demonstrates that a system functions as expected
in a controlled environment. A Performance Qualification verifies that a system works
under real-life conditions.

Quality Assurance Members of the organization who are tasked with ensuring the quality of materials
produced at that organization. GxP organizations are required to have robust and
independent Quality Assurance operations. Depending on the organization, this group
may be titled Quality Control or Quality Organization; other organizations have multiple
groups dedicated to quality with their own distinct missions.
Requirement Something a system must be able to do.
Retrospective Validation of an existing system. Retrospective validations are usually performed in
response to a new need for a system to be compliant or an identified gap in GxP
Validation compliance.
Specification A document outlining the requirements for a system. Specifications are usually sub-
divided into User Requirements Specifications, Functional Requirements, and Design
Specifications.
System Object or process undergoing validation. In these pages, system is intended to be a generic
term, meaning computer system, Instrument, method or process to be validated.

System Owner The individual who is ultimately responsible for a system.

Test Case A documented procedure, used to test that a system meets a particular requirement or
collection of requirements.
Test Plan A general testing methodology established to ensure that a system meets requirements. A
Test Plan can also refer to the collection of protocols or qualifications used to test and
document that a system meets requirements.
Test Step An individual line of a Test Case. Each Test Step should include instructions, an expected
result, and an actual result.
Traceability The ability to ensure that requirements outlined in the specifications have been tested.
This is usually recorded in a Requirements Traceability Matrix.
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Term Definition
Validation A documented process, testing a system to demonstrate and ensure its accuracy,
reliability, and consistent intended performance.
Validation A collection of documents produced during a validation project.
Package

8.0 EXECUTION INSTRUCTIONS:

Completion of IOQ will governed by the following procedures:
8.1 Prior to starting any test case, the individual(s) involved must be trained on the particular test
case(s) and any other procedure required in executing the test case(s).
8.2 Within the exception of the protocol approvers, each person who performs or reviews any section of
the tests within this document must complete/verify all information required.
8.3 All tests that are require the person executing the protocol make comparison, Calculation or a
Judgment of satisfactory completion, will Include “Pass” or “Fail” column. This section will
require the person executing the protocol to enter a disposition of each test or test step ass
appropriate.
9.1 If during the execution of the protocol Deviation occur it shall be documented and appropriate
corrective action shall be taken as per the predefined procedure for handling of Deviations.
9.2 Any comments regarding test Case(s) shall be recorded on the test sheet under the comments
section. If there is no comment, the comments shall be marked as NA for “Not Applicable”.
9.3 The “Reviewed by” signature line will be signed by an independent Reviewer who has read and
agrees the respective test case execution and conclusion.
9.4 All protocol entries will be completed using indelible Blue or Black Ink Pen.
9.5 General acceptance criteria:
If all the test case meet the acceptance criteria, the test case is successful and it passes. If a test
case does not meet expected results, a deviation document will be created, an investigation will be
conducted to determine cause of failure, and after the proper deviation form and corrective
action(s) are completed, the test may be repeated if required. The Re-Test data must also be
included as an attachment to the referenced Deviation form. If the corrective actions and re-tests
fail then the protocol approvers may consider and Qualification effort as failed and will determine
other actions necessary to address the impact of the failure; e.g., immediate halt on the use of the
Instrument, additional characterization and re-design, further investigation of root cause(s) etc.
For closure of the protocol, all the test cases must be successfully completed and all deviations
must be addressed and resolved. Once these steps have been accomplished, the IOQ will be
considered completed and closed.
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9.0 INSTALLATION QUALIFICATION:

a. Test Purpose: The purpose of this test is to verify the hardware and software installed in the computer system used for HPLC.
b. Test Method: Record results in the appropriate row of the following table. Where possible, screenshots or other documented
evidence may be included as supporting evidence and attached to this document with appropriate document number and other
sequential information.
c. Acceptance Criteria: All the expected results must match the actual results for each test step.

9.1 TEST TABLE:

S.No. Test Step Expected Results Actual results Pass/Fail Reference
1. Pre Requisites All IQ Pre-Requisite items are System used for HPLC is Protocols And Validation Plan
verification. completed successfully and fully installed as per URS and
approved. Approval for all the Pre-
Requisite is successful and fully
approved.
2. Manuals and All required manuals and technical All manuals and Technical SOP for Operation Of
Technical documentation relating to the Information related to Computer System.
Documents computer system Hardware, Operating system,
and installed software found
available for the system.
3. System Each of the identified system After running system Report of System Information
Instrumentation instrumentation components has information Software, all Software.
verification been installed and range / resolution, system instrumentation Annexure-I
manufacturer and model no. meet Components found installed
specification. within predefined range/
resolution. Manufacturer and
model no information. Meets
the specification.
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S.No. Test Step Expected Results Actual results Pass/Fail Reference

4. Preventive The Instrument shall be included on Schedule for Preventive
maintenance, sparethe site PM system record and have Maintenance and record for the
and significant been maintained as per schedule. same and list of all the
Parts List Recommended spare parts and recommended spares found
Verification significant parts list are included in available.
the PM system record.
5. Software/Hardware The Software and Hardware All the genuine Software and
computer installed meets the design Hardware used in the System
Installation specifications and are under change are as per Pre –Defined
control. Specifications as per URS. And
are under change control.
6. Security User Shall not Access the system Access to system is properly
Verification configuration. System is properly password protected, User
password protected. cannot access to configuration
of the System, Only
Administrator have the rights to
do so.
7. Loss of Utility Upon loss and restoration of utility Upon Loss and Restoration of
Verification the Instrument will respond as Utility. The Instrument will
expected. When the utility is respond as expected as the
restored, the Instrument /system will backup policy is applied.
retain critical parameters or settings
and return to a pre-defined safe state
or in the event where parameters
change, procedures are in place to
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S.No. Test Step Expected Results Actual results Pass/Fail Reference

address recovery of operational
parameters.
8. Alarms, Interlocks Safety and ergonomics assessment Safety Ergonomics assessment
and Safety form has been completed and form is completed and
Ergonomics approved. Alarms/ Interlocks/ and approved.
Verification Safety functions meet design Safety functions meets the
specification. design specifications.
9. Sequence of The sequence operation Meets the Sequence of Operations meets
Operations design specification. design specifications

Acceptance criteria:
 The Documents listed in the test result sheet should be available, readable and complete.
Actual result meets acceptance criteria:
 (Yes/No) __________

Tests performed By: Date Sign

Tests Reviewed By: Date Sign

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Comments / Deviations:

10.0 RECORDED VERIFICATIONS DURING INSTALLATION QUALIFICATION:

a. Test Purpose: The purpose of this section of the report is to record the data in the test table of IQ and is intended to:
 Describe the system to be validated.
 Verify and document that each major /Critical component is installed as specified.
 Measure and record temperature and humidity of the room where the computer system is installed.
 Verify that the electrical utility has been installed and is available as specified/Required.
 Verify physical and logical security available in the Computer System and Installed Software.
 Verify that the operating system software, antivirus software and other required software are installed in the
computer system.
 Verify user operation training record.

b. Test Method: Record the results in the appropriate row of test table, where possible, screenshots or other documented
evidence may be included as supporting evidence and attached to this document with appropriate document number and
other sequential information.
c. Acceptance Criteria: All expected results must match the Actual result.
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10.1 TEST STEPS: Hardware, Software and Documentation requirement.

S.No. Test Step Description Expected Results Actual Results Pass/Fail

1. Clint Station Computer Name .........
Identification Location of System INSTRUMENT ROOM
Purpose of system For HPLC
Manufacturer Hewlett-Packard
User Administrator
2. Verification of Computer Type Desktop PC
System Hardware CPU Type Intel Core i5-8500 @ 3.00GHz
and Interface Motherboard Name .........
Components System Memory/ 8+8 GB/ DDR4 SDRAM/ 1333.3 MHz
Type/Speed
Monitor Compaq 8191
Keyboard ..........
Mouse HP USB Optical Mouse
Drive Capacity Toshiba DT01ACA100 1000GB/7200 RPM
Primary IP Address ...........
BIOS Version DMI Based Version 3.2
Wake-Up Type Normal
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S.No. Test Step Description Expected Results Actual Results Pass/Fail

Boot-Up State Secure Boot
Power Supply State Ok
Thermal State Ok
Error Detection/ Ok
Correction
Current Power Source AC
Battery NO
Battery Type NA
Chassis Cooling Fan OK
Power Supply Fan OK/1559 RPM
Automatic Clock control OK
3. Verification of Physical Security System Should be Installed in lock and key
System Physical and Room
Logical Security Logical Security System Usage Should be as per User And
Administrator Level

4. Verification Of OS Name Windows 10 Professional

Operating System- OS Provider Microsoft Corporation
Software OS Version Microsoft Windows 64 bit OS
Virus/ Malware Integrated Windows Defender
Detection software
5. Verification of User User Training Record Proper Training records shall be available.
Training Records For Operation
6. Environmental Temperature 10°C to 25°C
Conditions Relative Humidity 55% ±5%
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S.No. Test Step Description Expected Results Actual Results Pass/Fail

7. Power Utilities Computer system Power AC 220 V
Supply
Earthing Voltage Less than 3 volt.
Power Backup UPS Supply Available
HPLC SOFTWARE REQUIREMENTS
8. Name of Clint Identification of Empower
Application Software Software Used HPLC
For HPLC
9. Version No. Identification Current 3.0
Version of the Software
used.
10. Manufactured By Identification of Waters
Manufacturer of
Software
DOCUMENTATION REQUIREMENTS
11. Hardware and Manuals contain critical Manuals of Hardware , Operating System and
Software Manual details of the Instrument Application Software shall be available.
and Application
Software.
12. Vendor Document Purchase Order and All the documents provided by the vendor
Vendor Approval and shall be available and reviewed.
DQ,IQ,OQ Documents.
13. Application Software Copy of genuine license All the Software used must have a current and
License Copy /Media of software and media in genuine license of software shall be available
which application along with the available along with the Media
in which Software is Stored.
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S.No. Test Step Description Expected Results Actual Results Pass/Fail

software in available
and stored.
14. Training Records Training of operation of Each User of the Software and Hardware shall
all the related users of be Trained for the operation and handling of
the Instrument and the Computer system and applicable Software.
Software.

Comments/Remarks:
 Data recorded from the system and room tag plates matches with the data specified in test data table.
 All the required records are available and found in place.
 Physical Installation of the computerized system is verified and details are recorded. Observed results are found
satisfactory.
 The computerized system room environmental conditions measured ad found within the limit.
 Power supply to the computerized system is within the limit.
 At least Two access level groups are available to login and access the computer system and Application software.
 User training for the system operation is available.
Actual result meets acceptance criteria:
 (Yes/No) __________

Tests performed By: Date Sign

Tests Reviewed By: Date Sign

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Comments / Deviations:

11.0 COMPUTER SYSTEM VALIDATION (Hardware and Software):

Qualification Test Test Result Meet
Acceptance Initial &
Date
Criteria

Verification of System Identity

Verification of System Documents
Verification of System Hardware and Interface Components
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Installation Verification of Environmental Conditions

Qualification
Verification of Utilities Requirements
Verification of System and Software Physical and Logical Security
Verification of Application Software Installed in System
Verification of User Operation Training Records

12.0 DISCREPANCY REPORT:

12.1 Discretion of Deficiency and its Classification:

S.No. Discrepancy/ Category

Deficiency
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13.1 Recommended Corrective Action Plan And Person Responsible:

S.No. Discrepancy/Deficiency Responsibility Category
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Provisional approval to proceed further with ibid Corrective Action(s) for Category B deficiency:

Initiated By User Department I.T. Quality Assurance

(Sign and Date) (Sign and Date) (Sign and Date) (Sign and Date)

13.2 Corrective Actions Taken:

Sr. No. Corrective Action Sign Date
Taken
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Closure Remarks: Allowed/ Not Allowed to Proceed Further

Reviewed and Approved by Projects:
Reviewed and Approved by Quality Assurance:

13.0 ACCEPTANCE CRITERIA:

Installation Qualification shall be considered acceptable when actual result/ observed results of all the conditions
specified in various data sheets as mentioned prior in this document matches with corresponding expected results.

Any deviation from the acceptance criteria of the specific check point shall be reported and decision should be taken for
the rejection, replacement or rectification of the computer system.
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14.0 SUMMARY:
All the installation and Operational Qualification tests for computerized system are performed as per written procedures
and protocols. The results observed during complete process are recorded and reviewed.

Observed results are found meeting acceptance criteria. During execution no discrepancies were found.

15.0 CONCLUSION:
The computer System Hardware and Operating System are tested and verified as per the guidelines described in
this document on the basis of approved protocols and other corresponding references.

The computer system stands Qualified as per the tests performed and observed results therein.

16.0 ABBREVIATIONS:
Acronym Description
°C Degree Celsius
21 CFR 11 Code of Federal Regulations, Title 21, Part 11 contains regulations with regards to electronic records and
signatures
AC Alternating Current
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Acronym Description
ALU Arithmetic and Logical Unit
AMD Advanced Micro Devices
API Application Programming Interface
AuthIP Authenticated Internet Protocol
AV Antivirus
BIOS Basic Input Output System
CD Compact Disc
CFR Code of Federal Regulations
CGI Common Gateway Interface
CGMP Current Good Manufacturing Practices
CMOS Complementary Metal-Oxide Semiconductor
CPU Central Processing Unit
CSV Computer System Validation
DC Direct Current
DMI Direct Media Interface
DVD Digital Versatile Disc
GAMP Good Automated Manufacturing Practices
GMP Good Manufacturing Practices
ID Identification
IQ Installation Qualification
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Acronym Description
NA Not Applicable
OQ Operational Qualification
OS Operating System
PC Personal Computer
RAM Random Access Memory
PH Relative Humidity
SOP Standard Operating Procedure
TCP/IP Transmitted Control Protocol/ Internet Protocol
UPS Uninterrupted Power Supply
V Volts
VAC Volts Alternating Current
VDC Volts Direct Current

17.0 LIST OF SUPPORTING DOCUMENTS:

Checked By
S.No. Description of Attachment Annexure No.
Sign. / Date
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18.0 DOCUMENT POST APPROVAL:

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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