Table of Content
- Introduction
- Purpose
- Scope
- Reference Documents
- System Description
- Role & Responsibilities
- General Instructions
- Pre-requisite
- Installation Qualification Strategy
- Installation Qualification Procedure
- Installation Qualification Error/Incident Reporting
- Error/Incident Log
- Attachment/Annexure
- Revision History
- Approval & Authorization
Introduction
In today's technologically-driven world, computer systems play a pivotal role in numerous industries, providing the backbone for data management, information processing, and decision-making. The reliability and functionality of these computer systems are of paramount importance, particularly in sectors where regulatory compliance, data integrity, and operational efficiency are critical. To ensure that a computer system is installed correctly and functions as intended, an Installation Qualification (IQ) report is an essential component of the validation process.
The Installation Qualification report is a structured and systematic documentation that outlines the rigorous verification and validation procedures undertaken during the installation of a computer system. By rigorously evaluating the installation process, the IQ report helps organizations demonstrate compliance with industry regulations, quality standards, and best practices.
In this report, we will explore the key elements and considerations involved in the Installation Qualification of a computer system, from the initial planning and execution phases to the comprehensive documentation of the installation process. The report will also highlight the significance of the IQ report in maintaining data integrity, regulatory compliance, and the overall functionality and reliability of computer systems.
As we delve into the specifics of the Installation Qualification process, we aim to provide a comprehensive understanding of the steps involved, the critical parameters assessed, and the importance of adhering to industry-specific guidelines. Through this report, organizations can gain valuable insights into how to effectively manage the installation of computer systems and ensure they meet the requisite quality and regulatory standards.
Ultimately, the Installation Qualification report serves as a testament to an organization's commitment to quality assurance and data integrity, reinforcing the trust and confidence placed in the computer systems upon which modern businesses and industries rely.
Purpose
The purpose of this document is to provide documentary evidence to ensure that the Installation qualification completed successfully.
Scope
The scope of this document is to provide summary and details of attachments of the Performed installation qualification for PC use in Warehouse.
Reference Documents
SOP for Validation of Computerized System.
System Description
- The system is a PC that provides server based security and interface to the use of software connected to an analytical instrument to execute their function.
- In Installation Qualification, the system is used to check proper installation of components (Hardware & Software) of the system with proper utility.
ALSO READ: Checklist for Supplier Qualification
Roles & Responsibilities
The following department personal involving in activity shall be responsible:
|
Roles |
Responsibilities |
|
QC/IT (Executive/Officer) |
Preparation
of this report |
|
QC (Operating
Manager) |
Review of
this report |
|
QA (Operating
Manager) |
Review of
this report |
|
QA (Head) |
Approval
of this report |
General Instruction
- Good documentation practices shall be followed during documentation.
- Do not leave any blank spaces. Use NA where ever applicable.
Pre-requisite
- Annexure I “Installation Qualification Test Script for PC” should be executed.
- All attachments related to execute document should be available.
Installation Qualification Strategy
Not Applicable
Installation Qualification Procedure
The Installation Qualification (IQ) procedure is a structured and methodical approach to ensuring that a computer system is installed correctly and complies with industry regulations and quality standards. It is a critical phase in the validation process, safeguarding data integrity and system reliability.
Installation Qualification Error/Incident Reporting
- The installation qualification for PC has been successfully executed and no discrepancy found during execution. All tests have been executed and evidence is captured and attached.
- Overall Test Status: Pass.
Error/Incident Log
|
Sr. No. |
Test Script
Number |
Incident/Deviation |
Description
of the Incident/Deviation |
Incident/Deviation
Number |
Status
(Open/Closed) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Attachment
Attachment 1 - Installation Qualification Test Script for PC
Attachment 2 - Installation Qualification Test Script for PC
Revision History
Nil
Tags
Qualification
