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Qualification For Walk In Chamber ( STABILITY DATA ACQUSITION SOFTWARE)

Qualification For Walk In Chamber ( STABILITY DATA ACQUSITION SOFTWARE)

Introduction

Purpose

The purpose of this Qualification Plan (QP) is to define the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Testing activities for the qualification of WALK IN CHAMBER, STABILITY DATA ACQUSITION SOFTWARE to be deployed at Quality Unit, for the users in the Quality Control/ Stability department.

Objectives

The objectives of this QP are to ensure that all Qualification Testing (IQ, OQ, and PQ) will challenge the requirements defined in the User Requirements Specification (URS) document for WALK IN CHAMBER; STABILITY DATA ACQUSITION SOFTWARE.  The results of the Qualification Tests will ensure that WALK IN CHAMBER; STABILITY DATA ACQUSITION SOFTWARE will satisfactorily perform the required functions and behave correctly, consistently, and reliably in its operating environment.

System Overview

Background

The STABILITY DATA ACQUSITION SOFTWARE  system is a Configurable Commercial-Off-The-Shelf (COTS) system . The STABILITY DATA ACQUSITION SOFTWARE packages, are designed to monitor and control the temperature and humidity data received from Enviro/Scanner of the Walk in Type Chamber. This software has the facility to generate envirowise/scannerwise report of temperature and humidity in graphical/tabular form.

Expected Business-Related Benefits

The system is expected to provide the following business-related benefits:

  1. The software will generate secure, integrated and traceable data.
  2. The time of analysis will reduce.
  3. Full audit trial support and compliance to regulatory requirements will be addressed.
  4. Relevant tests which were sent for testing to other laboratories will be conducted In-House.

Scope

Assumptions

There are no assumptions that apply to this QP.

Exclusions

There are no exclusions that apply to this QP.

Limitations

There are no limitations that apply to this QP.

Roles and Responsibilities

The roles and responsibilities associated with this project are defined in the Project Validation Plan (PVP).  This section defines the additional roles and responsibilities that are specific to the Qualification Testing of the system, as follows:

Role Responsibilities
Management i.      Responsible for the completion of the Qualification Tests.

ii.    Responsible for the appointment of Qualification Test resources.

iii.   Reviews and approves the Qualification Plan.

iv.   Responsible for the closure and/or acceptance of all discrepancies that occur during test execution.

v.    Reviews and approves the results of the Qualification Tests summarized in the Validation Summary Report (VSR).

Tester(s)

& Vendor

i.      Prepares the Qualification Test Scripts / Protocols for Hardware IQ, OQ and PQ for software.

ii.    Co-ordinate with vendor for software IQ and OQ Test script/ Protocol

iii.   Creates prerequisite test data prior to test execution.

iv.   Executes the Qualification Test Scripts / Protocols.

v.    Documents discrepancies that occur during test execution.

vi.   Assists in the resolution of discrepancies that occur during test execution.

Technical Reviewer(s) i.      Accountable for the technical aspects of the Qualification Tests.

ii.    Reviews Qualification deliverables, including pre-executed Qualification Test Scripts / Protocols, Discrepancy Forms and Qualification Test Reports.

iii.   Performs Technical Reviews on the Qualification deliverables which focus on the completeness and accuracy of the technical aspects of the project to ensure that the deliverables are technically correct and meet the technical requirements of the project.

iv.   Assists in the resolution of discrepancies that occur during test execution.

v.    Reviews the resolution of discrepancies that occur during test execution.

vi.   Assists in the development of the Discrepancy Log

Subject Matter Expert(s) (SME) i.      Accountable for the business aspects of the Qualification Tests.

ii.    Reviews Qualification deliverables, including pre-executed Qualification Test Scripts/Protocols, Discrepancy Forms and Qualification Test Reports.

iii.   Performs Subject Matter Expert (SME) Reviews on the Qualification deliverables that focus on the completeness and accuracy of the business aspects of the project to ensure that the deliverables are functionally correct and meet the user requirements of the project.

iv.   Assists in the resolution of discrepancy that occurs during test execution.

v.    Reviews the resolution of discrepancies that occur during test execution.

vi.   Assists in the development of the Discrepancy Log.

Validation (s)

 

 

 

 

 

i.      Accountable for the quality aspects of the Qualification Tests.

ii.    Assists team members in the use of the Qualification strategy.

iii.   Assists the team members in the development of the Qualification Plan.

iv.   Reviews Qualification deliverables, including Qualification Test Scripts/ Protocols, Signature Identification Log, Discrepancy Forms, Discrepancy Log and Qualification Test Reports.

v.    Performs Quality Reviews on the Qualification deliverables which focus on the completeness and accuracy of the quality aspects of the project to ensure that the deliverables are complete, consistent, clear, grammatically correct, and adhere to Good Documentation Practices (GDP), as well as comply with applicable policies, standards, and procedures.

vi.   Assists in the resolution of discrepancies that occur during test execution.

vii.  Reviews the resolution of discrepancies that occur during text execution.

viii. Assists in the development of the Discrepancy Log.

 Test Environments

 Production Environment

The Production environment will be configured with the following application software, hardware, operating system software, and utilities:

Component Type Specification
Minimum Requirements
Memory 2 GB
Hard Disk 160GB
Video 256 colors, 800X600
OS Windows XP Professional Version 2007 with

Service Pack 3

Qualification Strategy

Installation Qualification (IQ) for Hardware System

IQ Test Approach

The results of the IQ will ensure that the system will satisfactorily perform the required installation functions and behave correctly, consistently, and reliably in its operating environment.  That is, it will ensure that the system meets the installation needs of the users.

IQ Test Procedures

The following IQ Test Procedures will be executed during the IQ for the system:

Test Script ID Test Script Title Test Description Test Environment(s)
Configuration Testing The objective of this test is to check and document the configuration of the hardware. Production
Utility Testing Objective of this test script is to check the utility testing. Production

Operational Qualification (OQ) for hardware system

OQ Test Approach

The results of the OQ will ensure that the system will satisfactorily perform the required operational functions and behave correctly, consistently, and reliably in its operating environment.  That is, it will ensure that the system meets the operational needs of the users.

OQ Test Procedures

The following OQ Test Procedures will be executed during the OQ for the system:

Test Script ID Test Script Title Test Description Test Environment(s)
Hardware Component and Software Component Testing Objective of this test script is to check the operation of the Hardware and Software Components of the system Production

Installation Qualification (IQ) and Operational Qualification for Software System

IQ and OQ Test Approach

The IQ and OQ will be executed by the Vendor of the Equipment.  The results of the IQ and OQ will ensure that the system will satisfactorily perform the required installation functions and behave correctly, consistently, and reliably in its operating environment.  That is, it will ensure that the system meets the installation needs of the users.

Performance Qualification (PQ)

PQ Test Approach

The PQ will challenge the requirements defined in the User Requirements Specification (URS) document for the system.  The results of the PQ will ensure that the system will satisfactorily perform the required performance/business functions and behave correctly, consistently, and reliably in its operating environment.  That is, it will ensure that the system meets the performance/business needs of the users.

PQ Test Procedures

The following PQ Test Procedures will be executed during the PQ for the system:

Test Script ID Test Script Title Test Description Test Environment(s)
To check Business Activity/Functionality Requirements To check the functionality of the system as per User Requirements Production
To check User ID/Password and audit trail Requirements To check the User ID/Password and system audit trail of the system as per user requirements. Production

Qualification Test Execution

Using Testing Tools and Techniques

Testing tools will not be used during the Qualification Tests for the system.

Creating/Defining Test Data

All Test Data will be created/defined prior to test execution and will be identified in the Test Setup Data section and/or Test Data column of each application Qualification Test Script.

Recording Test Results

Qualification Test results will be recorded on test script forms as follows:

  1. All entries will be recorded in permanent black or blue ink.
  2. All entries will be recorded legibly.
  3. All entries will be recorded in printed handwriting, including test results, notes, and tester initials.
  4. All Testers, Technical Reviewers, and Quality/Validation Reviewers will print and sign their full names with the current date, where appropriate.
  5. The date format will be consistent to indicate the current date (where required), as dd/mmm/yyyy.
  6. Corrections to entries will be crossed out using a single line so that the original text is readable, corrected, initialed, and dated by the person performing the correction. It is recommended that a reason for the change or correction should be stated. The following reason codes can be used for minor corrections where applicable:
    1. Spelling Error – misspelling of a word or phrase
    2. Date Error – entering wrong date
  • Entry Error – data results or system information incorrectly entered
  1. All test scripts and test supporting documentation will be signed and/or initialed and dated by the person recording the data at the time of test execution.
  2. All comments will be summarized in the appropriate Comments sections of each test script.
  3. White out, erasures, checkmarks, highlighters, and asterisks will not be used during test execution.
  4. Test procedures, test results, and page number will not be written over during test execution.
  5. The actual test results or references to attached printouts will be recorded in the Actual Results column.
  6. When the actual result is exactly as indicated in the Expected Results column, then the Test Step will be recorded as Pass. Otherwise, if the result is not exactly as indicated in the Expected Results column, then the Validation personnel will assist the Tester in determining whether the Test Step failed and/or whether there is a discrepancy associated with the Test Step.
  7. When the result is not exactly as indicated in the Expected Results column, then Fail will be recorded in the Pass/Fail column for the Test Step and the sequential number of the discrepancy from the Discrepancy Form created for the failed Test Step will be recorded in the Discrepancy Number column.

Reviewing Test Results

The Qualification Test results will be reviewed, as follows:

  1. A Technical Review of the IQ and OQ Test results will be performed by the Vendor or Technical Reviewer which will focus on the completeness and accuracy of the technical aspects of the project to ensure that the deliverables are technically correct and meet the technical requirements of the project.
  2. A Technical/Business Review of the PQ Test results will be performed by the Subject Matter Expert (SME) which will focus on the completeness and accuracy of the business aspects of the project to ensure that the deliverables are functionally correct and meet the user requirements of the project.

Qualification Test Deliverables

The following Qualification Test deliverables will be produced during the Qualification Tests for the system:

Qualification Deliverable Template/Form Description
Qualification Plan This document, which defines the IQ, OQ, and PQ Testing activities for the qualification of the system.  In addition, this document ensures that all Qualification Testing will challenge the requirements defined in the URS documents for the system.
Installation Qualification Test Scripts (Hardware) The Installation Qualification Test Scripts identify the test script ID, test script title, description, test objective, acceptance criteria, execution instructions, prerequisites, and test setup data for each installation test procedure.  They also list the installation test procedures, test data, and expected results for each test step.  In addition, each IQ Test Script contains pre-execution and post execution approval signatures.
Operational Qualification Test Scripts (Hardware) The Operational Qualification Test Scripts identify the test script ID, test script title, description, test objective, acceptance criteria, execution instructions, prerequisites, and test setup data for each operational test procedure.  They also list the operational test procedures, test data, and expected results for each test step.  In addition, each OQ Test Script contains pre-execution and post execution approval signatures.
Installation and Operational Qualification Test Protocol Number : The Installation Qualification and Operational Qualification Test Scripts of the Walk in chamber (Thermolab), Stability Data Acquisition Software, version 7.4T,application software will detail the environmental and facilities requirements necessary for proper installation and qualification.
Performance Qualification Test Scripts (Software System) The Performance Qualification Test Scripts identify the test script ID, test script title, description, test objective, acceptance criteria, execution instructions, prerequisites, and test setup data for each business test procedure.  They also list the business test procedures, test data, and expected results for each test step.  In addition, each PQ Test Script contains pre-execution and post execution approval signatures.
Signature Identification Log The Signature Identification Log provides a record of each individual who signs and/or initials the Qualification Plan (as well as any page of the pre-executed and executed Qualification Test Scripts) for the qualification of the system.
Discrepancy Form The Discrepancy Forms record information about a specific Discrepancy that occurs during execution of the Qualification Tests, including the Discrepancy number, type, severity, description, and resolution.
Discrepancy Log The Discrepancy Log records all of the discrepancies that occur during the execution of the Qualification Tests.
Screen Print Attachments The Screen Print Attachments provide a tool on which to capture the screen images and test results

Discrepancy Resolution

Discrepancy Forms/Log

All discrepancies reported during Qualification Testing will be documented on Discrepancy Form, which will identify the Discrepancy number, type, severity, description, and resolution.  The details of the discrepancy forms generated during the testing will be recorded on Discrepancy Log, which will summarize the status of all the discrepancies reported during the Qualification Testing.

Discrepancy Types

All discrepancies that occur during Qualification Testing will be assigned a discrepancy type, as follows:

Discrepancy Type Description
System The discrepancy is due to a failure of the application software.
Environmental/Setup The discrepancy is due to environmental and/or configuration parameters being set up improperly.
Script The discrepancy is due to the test script being incorrect.
Tester The discrepancy is due to an error on the Tester’s part when executing the test script.
Other The discrepancy is due to causes not covered by the other Discrepancy types.

Discrepancy Severity Levels

All discrepancies that occur during Qualification Testing will be assigned a severity level, as follows:

Severity Level Description
Low Discrepancies which are cosmetic in nature and do not impact planned procedures.
Medium Discrepancies that result in a momentary interruption in processing or discrepancy from planned procedures which can be documented and justified through a workaround.
High Discrepancies that result in a sustained interruption in processing, loss/corruption of data, or discrepancy from a regulatory requirement for which a workaround would not be an acceptable practice.  These Discrepancies must be corrected in order to accept the testing.

Acceptance Criteria

The Qualification Tests will be considered acceptable when all of the following conditions are met:

  1. The Qualification Test Scripts identified in this Qualification Plan have been successfully executed and the results are as expected.
  2. The modifications made to resolve any discrepancies have been successfully re-tested.
  3. Workarounds for outstanding failures have been identified.
  4. All discrepancies have been closed and/or open discrepancies have been accepted and fully explained and documented in the VSR.

Qualification Test Summary

After completion of Qualification Testing, the Qualification Test results will be summarized in the VSR.

Attachments

There are no attachments in this QP.

 

 

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