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Type of software

Source software

☑Application software

☐System software

☐Programing software

☐Driver software

☑Closed source software

☐Open source software

  1. Software life cycle overview

    1. Version 1.0-1.1

...

Version

...

Activity

...

Requirements and system acceptance test specification

...

Date/ Initials

...

V1.0 – V1.1

...

Task

...

Requirements specification

...

ThangVX

AnhMTV

...

Method

...

Peer review

...

Check

...

Requirements specification approved

...

HieuDD

...

Design and implementation

...

Task

...

Design and development planning

HieuDD

...

Method

...

Peer review

...

Task

...

Design

...

DuongMT

...

Method

...

Peer review

...

HieuDD

...

Check

...

Design approved

...

HieuDD

...

Coding

...

Task

...

Coding

...

AnhMTV

ThangVX

LinhTM

TienLQ

...

Method

...

Peer review

...

AnhMTV

ThangVX

LinhTM

TienLQ

...

Task

...

Unit test

...

AnhMTV

ThangVX

LinhTM

TienLQ

...

Method

...

Peer review

...

AnhMTV

ThangVX

LinhTM

TienLQ

...

Check

...

Deploy to test environment

...

ThangVX

...

Inspections and testing

...

Task

...

Test plan

...

ThaoVT

...

Method

...

Peer review

...

ThangVX

ThaoVT

...

Check

...

Test plan approved

...

ThangVX

...

Task

...

Test case

...

ThaoVT

...

Method

...

Peer review

...

ThangVX

...

Check

...

Test report/ Test approved

...

ThaoVT

...

Installation and system acceptance test

...

Task

...

Installation plan

...

ThangVX

...

Method

...

Peer review

...

AnhMTV

HieuDD

LinhTM

TienLQ

...

Check

...

Installation plan approved

...

HieuDD

...

Method

...

Verification and test of installation

...

ThaoVT

...

Task

...

System acceptance test preparation

...

ThangVX

ThaoVT

HieuDD

...

Method

...

System acceptance test

...

ThaoVT

...

Check

...

System acceptance test approved

...

HieuDD

...

Performance, servicing, maintenance, phase out

...

Task

...

Phase out

...

ThangVX

...

Method

...

Peer review

...

HieuDD

  1. Version 1.2

...

Version

...

Activity

...

Requirements and system acceptance test specification

...

Date/ Initials

...

V1.2

...

Task

...

Requirements specification

...

ThangVX

AnhMTV

...

Method

...

Peer review

...

Check

...

Requirements specification approved

...

HieuDD

...

Design and implementation

...

Task

...

Design and development planning

HieuDD

...

Method

...

Peer review

...

Task

...

Design

...

DuongMT

...

Method

...

Peer review

...

HieuDD

...

Check

...

Design approved

...

HieuDD

...

Coding

...

Task

...

Coding

...

AnhMTV

ThangVX

LinhTM

TienLQ

...

Method

...

Peer review

...

AnhMTV

ThangVX

LinhTM

TienLQ

...

Task

...

Unit test

...

AnhMTV

ThangVX

LinhTM

TienLQ

...

Method

...

Peer review

...

AnhMTV

ThangVX

LinhTM

TienLQ

...

Check

...

Deploy to test environment

...

ThangVX

...

Inspections and testing

...

Task

...

Test plan

...

ThaoVT

...

Method

...

Peer review

...

ThangVX

ThaoVT

...

Check

...

Test plan approved

...

ThangVX

...

Task

...

Test case

...

ThaoVT

...

Method

...

Peer review

...

ThangVX

...

Check

...

Test report/ Test approved

...

ThaoVT

...

Installation and system acceptance test

...

Task

...

Installation plan

...

ThangVX

...

Method

...

Peer review

...

AnhMTV

HieuDD

LinhTM

TienLQ

...

Check

...

Installation plan approved

...

HieuDD

...

Method

...

Verification and test of installation

...

ThaoVT

...

Task

...

System acceptance test preparation

...

ThangVX

ThaoVT

HieuDD

...

Method

...

System acceptance test

...

ThaoVT

...

Check

...

System acceptance test approved

...

HieuDD

...

Performance, servicing, maintenance, phase out

...

Task

...

Phase out

...

ThangVX

...

Method

...

Peer review

...

HieuDD

  1. Version 1.3

...

Version

...

Activity

...

Requirements and system acceptance test specification

...

Date/ Initials

...

V1.3

...

Task

...

Requirements specification

...

ThangVX

AnhMTV

...

Method

...

Peer review

...

Check

...

Requirements specification approved

...

HieuDD

...

Design and implementation

...

Task

...

Design and development planning

...

ThangVX

HieuDD

...

Method

...

Peer review

...

Task

...

Design

...

ThangVX

...

Method

...

Peer review

...

HieuDD

...

Check

...

Design approved

...

HieuDD

...

Coding

...

Task

...

Coding

...

AnhMTV

ThangVX

LinhTM

TienLQ

...

Method

...

Peer review

...

AnhMTV

ThangVX

LinhTM

TienLQ

...

Task

...

Unit test

...

AnhMTV

ThangVX

LinhTM

TienLQ

...

Method

...

Peer review

...

AnhMTV

ThangVX

LinhTM

TienLQ

...

Check

...

Deploy to test environment

...

ThangVX

...

Inspections and testing

...

Task

...

Test plan

...

NhungPTT

...

Method

...

Peer review

...

ThangVX

...

Check

...

Test plan approved

...

ThangVX

...

Task

...

Test case

...

NhungPTT

...

Method

...

Peer review

...

ThangVX

...

Check

...

Test report/ Test approved

...

NhungPTT

...

Task

...

Test performance

...

N/A

...

Method

...

Test report

...

ThaoNT

...

Installation and system acceptance test

...

Task

...

Installation plan

...

ThangVX

...

Method

...

Peer review

...

AnhMTV

LinhTM

TienLQ

NhungPTT

HieuDD

...

Check

...

Installation plan approved

...

HieuDD

...

Method

...

Verification and test of installation

NhungPTT

...

Task

...

System acceptance test preparation

...

ThangVX

...

Method

...

System acceptance test

...

NhungPTT

...

Check

...

System acceptance test approved

...

NhungPTT

HieuDD

...

Performance, servicing, maintenance, phase out

...

Task

...

Phase out

...

ThangVX

...

Method

...

Peer review

...

HieuDD

  1. Version 1.4

...

Version

...

Activity

...

Requirements and system acceptance test specification

...

Date/ Initials

...

V1.4

...

Task

...

Requirements specification

...

ThangVX

...

Method

...

Peer review

...

Check

...

Requirements specification approved

...

HieuDD

...

Design and implementation

...

Task

...

Design and development planning

...

MinhVD

LinhTM

...

Method

...

Peer review

...

Task

...

Design

...

ThangVX

...

Method

...

Peer review

...

ThangVX

MinhVD

LinhTM

...

Check

...

Design approved

...

ThangVX

...

Coding

...

Task

...

Coding

...

LinhTM

MinhVD

...

Method

...

Peer review

...

LinhTM

MinhVD

ThangVX

...

Task

...

Unit test

...

LinhTM

MinhVD

ThangVX

...

Method

...

Peer review

...

ThangVX

...

Check

...

Deploy to test environment

...

ThangVX

...

Inspections and testing

...

Task

...

Test plan

...

NhungPTT

...

Method

...

Peer review

...

NhungPTT

...

Check

...

Test plan approved

...

NhungPTT

...

Task

...

Test case

...

NhungPTT

...

Method

...

Peer review

...

NhungPTT

...

Check

...

Test report/ Test approved

...

NhungPTT

...

Task

...

Test performance

...

N/A

...

Method

...

Test report

...

NhungPTT

...

Installation and system acceptance test

...

Task

...

Installation plan

...

ThangVX

...

Method

...

Peer review

...

NhungPTT

LinhTM

MinhVD

HieuDD

...

Check

...

Installation plan approved

...

HieuDD

...

Method

...

Verification and test of installation

NhungPTT

...

Task

...

System acceptance test preparation

...

ThangVX

...

Method

...

System acceptance test

...

NhungPTT

...

Check

...

System acceptance test approved

...

NhungPTT

HieuDD

...

Performance, servicing, maintenance, phase out

...

Task

...

Phase out

...

MinhVD

LinhTM

...

Method

...

Peer review

...

HieuDD

  1. Version 1.5

...

Version

...

Activity

...

Requirements and system acceptance test specification

...

Date/ Initials

...

V1.5

...

Task

...

Requirements specification

...

ThangVX

...

Method

...

Peer review

...

Check

...

Requirements specification approved

...

HieuDD

...

Design and implementation

...

Task

...

Design and development planning

...

HieuDD

ThangVX

...

Method

...

Peer review

...

Task

...

Design

...

HieuDD

...

Method

...

Peer review

...

ThangVX

...

Check

...

Design approved

...

HieuDD

...

Coding

...

Task

...

Coding

...

ThangVX

LinhTM

...

Method

...

Peer review

...

ThangVX

LinhTM

...

Task

...

Unit test

...

ThangVX

LinhTM

...

Method

...

Peer review

...

ThangVX

LinhTM

...

Check

...

Deploy to test environment

...

ThangVX

...

Inspections and testing

...

Task

...

Test plan

...

NhungPTT

...

Method

...

Peer review

...

NhungPTT

...

Check

...

Test plan approved

...

NhungPTT

...

Task

...

Test case

...

NhungPTT

...

Method

...

Peer review

...

NhungPTT

...

Check

...

Test report/ Test approved

...

NhungPTT

...

Task

...

Test performance

...

N/A

...

Method

...

Test report

...

NhungPTT

...

Installation and system acceptance test

...

Task

...

Installation plan

...

ThangVX

...

Method

...

Peer review

...

NhungPTT

HieuDD

...

Check

...

Installation plan approved

...

HieuDD

...

Method

...

Verification and test of installation

NhungPTT

...

Task

...

System acceptance test preparation

...

ThangVX

...

Method

...

System acceptance test

...

NhungPTT

...

Check

...

System acceptance test approved

...

NhungPTT

HieuDD

...

Performance, servicing, maintenance, phase out

...

Task

...

Phase out

...

ThangVX

NhungPTT

...

Method

...

Peer review

...

HieuDD

  1. Version 1.6

...

Version

...

Activity

...

Requirements and system acceptance test specification

...

Date/ Initials

...

V1.6

...

Task

...

Requirements specification

...

ThangVX

...

Method

...

Peer review

...

Check

...

Requirements specification approved

...

HieuDD

AnhMTV

NhungPTT

...

Design and implementation

...

Task

...

Design and development planning

...

HieuDD

AnhMTV

...

Method

...

Peer review

...

Task

...

Design

...

HieuDD

...

Method

...

Peer review

...

AnhMTV

ThangVX

NhungPTT

...

Check

...

Design approved

...

HieuDD

...

Coding

...

Task

...

Coding

...

AnhMTV

ThangVX

...

Method

...

Peer review

...

AnhMTV

ThangVX

...

Task

...

Unit test

...

AnhMTV

ThangVX

...

Method

...

Peer review

...

AnhMTV

ThangVX

...

Check

...

Deploy to test environment

...

ThangVX

...

Inspections and testing

...

Task

...

Test plan

...

NhungPTT

...

Method

...

Peer review

...

NhungPTT

...

Check

...

Test plan approved

...

NhungPTT

...

Task

...

Test case

...

NhungPTT

...

Method

...

Peer review

...

NhungPTT

...

Check

...

Test report/ Test approved

...

NhungPTT

...

Task

...

Test performance

...

N/A

...

Method

...

Test report

...

NhungPTT

...

Installation and system acceptance test

...

Task

...

Installation plan

...

HieuDD

ThangVX

...

Method

...

Peer review

...

AnhMTV

HieuDD

...

Check

...

Installation plan approved

...

HieuDD

...

Method

...

Verification and test of installation

...

NhungPTT

...

Task

...

System acceptance test preparation

...

ThangVX

AnhMTV

NhungPTT

...

Method

...

System acceptance test

...

NhungPTT

...

Check

...

System acceptance test approved

...

NhungPTT

HieuDD

...

Performance, servicing, maintenance, phase out

...

Task

...

Phase out

...

AnhMTV

...

Method

...

Peer review

...

HieuDD

  1. Software life cycle activities

Version 1.0-1.1

...

Version

...

Requirements and system acceptance test specification

...

Document/ Initials

...

V1.0 – V1.1

...

Features:

  • Setup Study

Create Study

Create CRF

Create Visit Definition

Create Subject Group Classes

Create Rules

Create Site

Assign User

  • Discrepancy Note

  • Data Set

  • Submit Data

  • Manage Rule

  • Manager User Schedule Visit

  • Manage User

...

Requirements specification

...

Software Requirement Specification: https://bit.ly/3vjcqJ9

...

Peer review

...

Requirements specification approved

...

Design and implementation

...

Design and development planning

...

Software Design Specification: https://bit.ly/3vhNDFk

...

Peer review

...

Design input

...

N/A

...

Peer review

...

Design approved

...

Coding

...

Coding

...

Build: xx – Build: xx

...

Peer review

...

Unit test

...

Peer review

...

Deploy to test environment

...

Inspections and testing

...

Test plan

...

https://bit.ly/3OQ8fMS  

...

Peer review

...

Test plan approved

...

Test case

...

https://bit.ly/3OHFge4  

...

Peer review

...

Test report/ Test approved

...

Test performance

...

N/A

...

Test report

...

https://bit.ly/3vkUwWk  

...

Installation and system acceptance test

...

Installation plan

...

https://bit.ly/3KdWPit  

...

Peer review

...

Installation plan approved

...

Installation summary

...

Installation procedure

...

Verification and test of installation

...

System acceptance test preparation

...

System acceptance test

...

System acceptance test approved

...

Performance, servicing, maintenance, phase out

...

Phase out

...

N/A

...

Peer review

Version 1.2

...

Version

...

Requirements and system acceptance test specification

...

Document/ Initials

...

V1.2

...

New features:

  • Login

Forgot password

Access home với các User

  • My Profile

  • Manage Study Subject 

  • Manage Study Visit

  • Manage Data

Source Data Verification 

Study Audit Log

Rules

Groups

CRFs

  • CRF History

  • Notes and Discrepancies Note: Action for View within record

  • Extract Data: 

Export Dataset

Export Case Book

...

Requirements specification

...

Requirement: https://bit.ly/3kdIkAv  

State changes: https://bit.ly/37Q5zhn  

...

Peer review

...

Requirements specification approved

...

Design and implementation

...

Design and development planning

...

Design requirement: https://bit.ly/37KiT6U  

...

Peer review

...

Design approved

...

Design changes

...

N/A

...

Peer review

...

Coding

...

Coding

...

Build: xx – Build: xx

...

Peer review

...

Unit test

...

Peer review

...

Deploy to test environment

...

Inspections and testing

...

Test plan

...

https://bit.ly/3EQ5iHj  

...

Peer review

...

Test plan approved

...

Test case

...

https://bit.ly/3vi740F  

...

Peer review

...

Test report/ Test approved

...

Test performance

...

N/A

...

Test report

...

https://bit.ly/3LnHrRZ  

...

Test case changes:

  1. Update Status of the Study Visit

  2. Update status of the Study Subject

...

  1. Update Status of the Study Visit: https://bit.ly/3LgIlj0  

  2. Update status of the Study Subject: https://bit.ly/3vlJFvG  

...

Peer review

...

Test approved

...

Installation and system acceptance test

...

Installation plan

...

https://bit.ly/3KdWPit  

...

Peer review

...

Installation plan approved

...

Installation summary

...

Installation procedure

...

Verification and test of installation

...

System acceptance test preparation

...

System acceptance test

...

System acceptance test approved

...

Performance, servicing, maintenance, phase out

...

Phase out

...

N/A

...

Peer review

Version 1.3

...

Version

...

5.1. Requirements and system acceptance test specification

...

Document/ Initials

...

V1.3

...

New features:

V1.3.1:

  • Task summary

V1.3.2:

  • eCRF Builder

  • Unit Dictionary

  • Response Set

V1.3.3

  • Randomization module

...

Requirements specification

...

V1.3.1: https://bit.ly/3EO5Cqh  

V1.3.2: https://bit.ly/3KlFX9w  

V1.3.3: https://bit.ly/3rTCvMT  

...

Peer review

...

Requirements specification approved

...

Design and implementation

...

Design and development planning

...

N/A

...

Peer review

...

Design approved

...

Design changes

...

N/A

...

Peer review

...

Coding

...

Coding

...

Build: xx – Build: xx

...

Peer review

...

Unit test

...

Peer review

...

Deploy to test environment

...

Inspections and testing

...

Test plan

...

https://bit.ly/3LswjDu  

...

Peer review

...

Test plan approved

...

Test case

...

https://bit.ly/3LjIy4Y  

...

Peer review

...

Test report/ Test approved

...

Test report

...

https://bit.ly/36P5om2  

...

Test case changes:

  1. Update Manage CRFs

...

https://bit.ly/38x5xv6  

...

Peer review

...

Test approved

...

Installation and system acceptance test

...

Installation plan

...

https://bit.ly/3KdWPit  

...

Peer review

...

Installation plan approved

...

Installation summary

...

Installation procedure

...

Verification and test of installation

...

System acceptance test preparation

...

System acceptance test

...

System acceptance test approved

...

Performance, servicing, maintenance, phase out

...

Phase out

...

N/A

...

Peer review

Version 1.4

...

Version

...

Requirements and system acceptance test specification

...

Document/ Initials

...

V1.4

...

New features:

V1.4.0:

  • Payment Module

  • Two-step verification

  • Visual Report Page

  • Data Notification

V1.4.1:

  • Update Export Dataset

  • Update Discrepancies Note

  • Update SDV to Item Level

...

Requirements specification

...

V1.4.0: https://bit.ly/3vlpIVL  

V1.4.1: https://bit.ly/3vNY1E0  

...

Peer review

...

Requirements specification approved

...

Design and implementation

...

Design and development planning

...

N/A

...

Peer review

...

Design approved

...

Design changes

...

N/A

...

Peer review

...

Coding

...

Coding

...

Build: xx – Build: xx

...

Peer review

...

Unit test

...

Peer review

...

Deploy to test environment

...

Inspections and testing

...

Test plan

...

https://bit.ly/3LB8s4B 

...

Peer review

...

Test plan approved

...

Test case

...

https://bit.ly/3ODwvBI  

...

Peer review

...

Test report/ Test approved

...

Test report

...

https://bit.ly/3MszcUG  

...

Test case changes:

  1. Update Export Dataset

  2. Update Discrepancies Note

  3. Update SDV

...

https://bit.ly/3OAlW2p  

...

Peer review

...

Test approved

...

Installation and system acceptance test

...

Installation plan

...

https://bit.ly/3KdWPit  

...

Peer review

...

Installation plan approved

...

Installation summary

...

Installation procedure

...

Verification and test of installation

...

System acceptance test preparation

...

System acceptance test

...

System acceptance test approved

...

Performance, servicing, maintenance, phase out

...

Phase out

...

N/A

...

Peer review

Version 1.5

...

Version

...

Requirements and system acceptance test specification

...

Document/ Initials

...

V1.5

...

New features:

  • Basic features on Tablet App

Log in

Log out

Personal settings

  • Subject Matrix

  • Home Page

  • Discrepancies Note

  • Entry Data

...

Requirements specification

...

https://bit.ly/3vJcTTX  

...

Peer review

...

Requirements specification approved

...

Design and implementation

...

Design and development planning

...

https://bit.ly/3EYvIXG 

...

Peer review

...

Design approved

...

Design changes

...

N/A

...

Peer review

...

Coding

...

Coding

...

Build: xx – Build: xx

...

Peer review

...

Unit test

...

Peer review

...

Deploy to test environment

...

Inspections and testing

...

Test plan

...

https://bit.ly/3rT7ito  

...

Peer review

...

Test plan approved

...

Test case

...

https://bit.ly/3OIE4XF  

...

Peer review

...

Test report/ Test approved

...

Test performance

...

N/A

...

Test report

...

https://bit.ly/3MBkACn  

...

Test case changes

...

N/A

...

Peer review

...

Test approved

...

Installation and system acceptance test

...

Installation plan

...

https://bit.ly/3KdWPit  

...

Peer review

...

Installation plan approved

...

Installation summary

...

Installation procedure

...

Verification and test of installation

...

System acceptance test preparation

...

System acceptance test

...

System acceptance test approved

...

Performance, servicing, maintenance, phase out

...

Phase out

...

Peer review

Version 1.6

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Version

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Requirements and system acceptance test specification

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Document/ Initials

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V1.6

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New features:

  • Enable ePRO module

  • ePRO App

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Requirements specification

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https://bit.ly/3KlrTgf  

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Peer review

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Requirements specification approved

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Design and implementation

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Design and development planning

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https://bit.ly/3Kj7aJV 

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Peer review

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Design approved

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Design changes

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N/A

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Peer review

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Coding

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Coding

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Build: xx – Build: xx

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Peer review

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Unit test

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Peer review

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Deploy to test environment

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Inspections and testing

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Test plan

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https://bit.ly/3KdZCrX  

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Peer review

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Test plan approved

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Test case

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https://bit.ly/3EOwTso 

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Peer review

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Test report/ Test approved

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Test performance

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N/A

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Test report

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https://bit.ly/3xUbwoc  

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Test case changes

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Peer review

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Test approved

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Installation and system acceptance test

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Installation plan

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https://bit.ly/3KdWPit  

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Peer review

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Installation plan approved

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Installation summary

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Installation procedure

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Verification and test of installation

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System acceptance test preparation

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System acceptance test

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System acceptance test approved

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Performance, servicing, maintenance, phase out

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Phase out

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Peer review

Conclusion

Conclusion: The modules are working as planned.

Signature: 

HieuDD

ThangVX