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VALIDATION PLAN FOR <PROJECT NAME>

Validation Plan
For
<Project Name>

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VALIDATION PLAN FOR <PROJECT NAME>

Table of Contents

1. INTRODUCTION.....................................................................................................................................................4
1.1 SYSTEM OVERVIEW...................................................................................................................................................4
1.2 DEFINITIONS & ACRONYMS.......................................................................................................................................4
1.3 PURPOSE..................................................................................................................................................................4
1.4 PROJECT OBJECTIVE AND SCOPE.................................................................................................................................4
1.4.1 Exclusions....................................................................................................................................................4
1.4.2 System Interfaces..........................................................................................................................................4
1.4.3 Entry and Exit Criteria for Testing..............................................................................................................4
1.5 ROLES, RESPONSIBILITIES, AND PROJECT DELIVERABLES................................................................................................4
1.6 VALIDATION PLAN UPDATES......................................................................................................................................5
1.7 DEVIATIONS FROM QUALITY.......................................................................................................................................5
2. MANAGEMENT PROCESSES DURING VALIDATION..................................................................................5
2.1 ASSUMPTIONS, DEPENDENCIES & CONSTRAINTS............................................................................................................5
2.2 USE OF TOOLS.........................................................................................................................................................5
2.3 PROJECT RISK MANAGEMENT & CONTINGENCY PLANNING............................................................................................5
2.4 SYSTEM RISK ANALYSIS............................................................................................................................................6
2.5 TESTING APPROACH..................................................................................................................................................6
2.6 VALIDATION METHODOLOGY AND QUALITY APPROACH.................................................................................................7
2.7 CHANGE MANAGEMENT.............................................................................................................................................7
2.8 PROBLEM MANAGEMENT...........................................................................................................................................7
2.9 SYSTEM CONFIGURATION MANAGEMENT......................................................................................................................7
3. MANAGEMENT PROCESS AFTER VALIDATION.........................................................................................7
3.1 MAINTAINING VALIDATED STATE...............................................................................................................................7

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VALIDATION PLAN FOR XXXX

Document History

Version Author Date of Release Summary of Changes


Number
See Header See Header Original Release

Applicable Documents and References

• <Name of the documents >

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VALIDATION PLAN FOR XXXX

1. Introduction
1.1 System Overview
<Describe the system overview>

1.2 Definitions & Acronyms

Term Definition
SRS System Requirements Specification

1.3 Purpose
<Describe the purpose of Validation Plan>

1.4 Project Objective and Scope


<Describe the Objectives and scope of the Project>

1.4.1 Exclusions
<Mention the list of items which shall not be explicitly tested as a part of this validation effort>

1.4.2 System Interfaces


<Mention the interfaces to the application>

1.4.3 Entry and Exit Criteria for Testing


<Describe the Entry and Exit criteria for the testing of the system>:

Entry Criteria:

Exit Criteria:

1.5 Roles, Responsibilities, and Project Deliverables


<Describe the different documents prepared for testing, who is responsible to create those
documents and who all will approved those>
The activities and responsibilities for the validation exercise are tabled as follows:

Validation Deliverable and Validation Develop Approval Signatory


Activities
Validation Plan SV BA, IT, SV
Software Requirements Specification BA BA, IT, SV

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VALIDATION PLAN FOR XXXX

Acronym Functional Group


BA Business Area
PM Project Manager
SV Systems Validation

1.6 Validation Plan Updates


<Describe the rule for updating the Validation Plan for eg. If needs updating it should go through
Change Control request>

1.7 Deviations from Quality


<Describe how the defect handling will be done>

2. Management Processes During Validation


2.1 Assumptions, Dependencies & Constraints
 <Mention different assumptions, dependencies &constraints for testing

2.2 Use of Tools


<Mentions what all tools will be used for testing>

2.3 Project Risk Management & Contingency Planning


The scope of this Project Risk Analysis is the identification of specific conditions that may
negatively impact the execution of this validation project and the mitigation of that risk. This
analysis examines the project-based risks.

Number Risk Severity Probability Mitigation


1. IT resources not High Low Have a backup IT resource
available identified.
2. Client resources not High Low Provide as much lead time as
available possible for this activity to facilitate
scheduling
3. Testing resources not High Low Establish project schedule early and
available locate resources
4. Schedule slippage High Low Project should be monitored daily
due to complexity of for progress and missed deadlines
effort
5. Deliverables from High Low Inform Vendor about the validation
Vendors not available deliverables and provide timelines
for their delivery.

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VALIDATION PLAN FOR XXXX

2.4 System Risk Analysis


The scope of this System Risk Analysis is to identify specific internal or environmental
conditions that may cause risks to a system and the mitigation of that risk. The analysis
examines the functional requirements of the system to determine how failure affects operation
and integrity.

Number Risk Severity Probability Mitigation


1. Security: High Low The system will be configured
 Unauthorized to address these issues.
user access. Please refer to security SOP,
 Inactive user still IT-SOP-207, Computer
on the list. Systems Physical and Logical
 User password Security.
does not age allowing Please refer to Corporate
for stolen and used Password Policy.
passwords.
2. Failure of Server High Low All the servers are located at
MasterControl’s site. As the
servers are backed up on a
regular basis, vendor will
follow backup and restore
procedures.
3. Servers are powered off Moderate Low All the servers are located at
due to loss of power. MasterControl’s site and the
servers are backed up by un-
interruptible power supply,
4. Production environment High Low A full backup will be
configuration does not performed prior to the move
match validation from Validation to Production.
environment Use existing configuration
information to rebuild the
application.

2.5 Testing Approach


<Mention the process of testing>

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VALIDATION PLAN FOR XXXX

2.6 Validation Methodology and Quality Approach


2.6.1 Requirements Testing Approach:
<Describe the approach of requirements testing>

2.6.2 User Acceptance Testing Approach:


<Describe the approach of User Acceptance testing>

2.6.3 Quality Approach:


<Describe the reviews done for quality>

2.7 Change Management


<Describe the process of change management>

2.8 Problem Management


<Describe how the defects record will be maintained>

2.9 System Configuration Management


<Describe about System Configuration Management>

3. Management Process After Validation


3.1 Maintaining Validated State
<Describe the process of maintenance of the application >

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