Oracle r12 Opm VMP 0.1

<Company Name>
Document Title
Oracle R12 e-Business Suite OPM Validation (Master) Plan
Filename/Document Identifier
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Type
System
<Doc ID>
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Oracle OPM for < Site >
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Oracle R12 Process e-Business suite
Validation (Master) Plan

for
Oracle Process Manufacturing
Approval
Completion of the following signature blocks signifies the approver has read, understands, and agrees with the
content of this document and that the document has been produced in accordance with applicable <Company>
Quality Standards.
Name
Job Title
Signature
Date
(dd-mmm-yyyy)
Prepared by:
Validation Consultant
Approved by:
Project Manager
Approved by:
Quality Assurance Manager
OPM Validation Master Plan
<Company Name>
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Revision History
Date
Version
Revised By
Reason For Revision
12 Apr 2011
0.1
Laila Rasmy
First Draft
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Table of Contents
1.
1.1.
1.2.
1.3.
1.4.
1.5.
1.6.
Introduction ........................................................................................................ 4
Purpose ............................................................................................................... 4
Objectives ............................................................................................................ 4
Scope .................................................................................................................. 4
System Description .............................................................................................. 4
OPM Overview .................................................................................................... 5
Oracle Methodology ............................................................................................ 5
2.
Vendor Status .................................................................................................... 6
3.
3.1.
Validation Lifecycle ........................................................................................... 7

Design Phase ...................................................................................................... 8
3.1.1.
3.1.2.
3.1.3.
3.1.4.
3.1.5.
3.1.6.
Validation Master Plan (VMP) ........................................................................................ 8

User Requirement Specification (URS) .......................................................................... 8
Functional Specification (FS) ......................................................................................... 9
Hardware Design Specification (HDS) ........................................................................... 9
System Design Specification (SDS) ............................................................................... 9
Code Review (CR) ....................................................................................................... 10
3.2.
3.3.
Risk Management .............................................................................................. 10

Testing Phase .................................................................................................... 11
3.3.1.
3.3.2.
3.3.3.
3.3.4.
3.3.5.
3.3.6.
3.3.7.
3.3.8.
3.3.9.
System Acceptance Test Specification (SATS)............................................................ 11

Hardware Acceptance Test Specification (HATS) ........................................................ 11
Functional Test Specification (FTS) ............................................................................. 12
User Acceptance Test Specification (UATS) ................................................................ 12
Hardware Acceptance Testing (HAT) .......................................................................... 12
System Acceptance Testing (SAT) .............................................................................. 13
Functional Testing (FT)................................................................................................ 13
User Acceptance Testing (UAT) .................................................................................. 13
Validation Reporting (VR) ............................................................................................ 14
4.
4.1.
4.2.
4.3.
4.4.
4.5.
4.6.
4.7.
On-going Operational Phase .......................................................................... 14

Maintenance Plan .............................................................................................. 14
Change Management ........................................................................................ 14
System Administration, Security and Access..................................................... 14
System Backup, Restore and Archiving ............................................................ 14
Training and Operating ...................................................................................... 14
CAPA Management ........................................................................................... 15
Performance Monitoring .................................................................................... 15
5.
Periodic Reviews ............................................................................................. 15
6.
Glossary ........................................................................................................... 15
7.
Regulations and Guidelines ........................................................................... 16
Appendix A - Specific Project Roles, Responsibilities and Key Deliverables Table . 17
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Introduction
This document is the <Company, Site> Validation Master Plan (VMP), containing all key
validation activities for the implementation of the Oracle R12 Process Manufacturing
System (OPM).
1.1.
Purpose
The purpose of this document is to detail the scope of validation activities that are to be
undertaken on the OPM System. In particular the boundaries of the validation and the
work content of the various activities will be detailed.
This document has been written in accordance with Appendix M1 in ISPE GAMP5* [1].
1.2.
Objectives
The prime objective of this document is to provide an organised and logical approach,
which helps to demonstrate a fully working, validated and compliant system.
In addition, documentation produced as a result will assist internal <Site> Management
and Regulatory Inspectors with future audit processes in order to ensure that the system
complies with all the latest relevant regulatory practices for example FDA, EU and GMP
practices.
1.3.
Scope
The scope of this document is to identify deliverables and responsibilities required for the
Oracle R12 Process Manufacturing (OPM) system validation.
1.4.
System Description
Oracle E-Business Suite is a complete set of business applications enabling you to cut
costs; increase revenues across front and back-office functions; and access current,
accurate, and consistent data.
The applications in Oracle E-Business Suite are built on a unified information architecture
that consolidates data from Oracle and non-Oracle applications and allows a consistent
definition of customers, suppliers, partners, and employees across the entire enterprise.
The result is a suite of integrated business applications, covering Financials, Logistics,
Manufacturing, and ancillary departments that can give you current performance metrics,
financial ratios, profit and loss summaries, and other types of information that roll up
across all departments, products, and geographies.
*GAMP is a registered trademark of the ISPE www.ispe.org
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1.5.
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OPM Overview
Oracle Process Manufacturing (OPM) automates the entire product lifecycle for recipebased manufacturing, from new product development, recipe management and
production, to cost, quality, and regulatory management.
It enables you to formulate products to individual customer specifications, manage
variability, optimize capacity, and drive continuous process improvement.
1.6.
Oracle Methodology
Oracles uses its own implementation methodology (AIM). The diagram below denotes the
format for the Alfa prefix for the document identification number & at what time the
relevant document is generally used during an implementation.
Definition
Operations
Analysis
Solution
Design
Build
Transition
Production
Business Process Architecture (BP)

Business Requirements Definition (BR)
Business Requirements Mapping (RD)
Application & Technical Architecture (TA)
Module Design & Build (MD)
Data Conversion (CV)
Documentation (DO)
Business System Testing (TE)
Performance Testing (PT)
Application & Learning (AP)
Production Migration
During Definition phase the Oracle project team plan the project, review the organizations
business objectives, analyze the business processes, and evaluate the feasibility of
meeting those objectives under time, resource and budget constraints.
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Vendor Status
Oracle is an industry renowned supplier of computerised systems software founded in
1977 and currently estimated to be employing over 118,000 personnel globally with its
main headquarters in Redwood Shores, California USA.
Oracle Corporation (NASDAQ: ORCL) is recognised as the worlds largest enterprise
software company, providing enterprise software to more than 390,000 customers
including 100 of the Fortune 100and with deployments across a wide variety of
industries in more than 145 countries around the globe. With annual revenues of more
than $37 billion, the company offers its database, tools and application products, along
with related consulting, education, and support services.
Oracle Egypt has been involved with over 170 E-Business Suite system implementations,
which includes pharmaceutical companies in Egypt either directly or through one of its
officially approved and trained partners.
Oracle Egypt is a branch office of Oracle, which also operates one of the Oracle global
support centres.
Due to the strong global position of Oracle and its wide usage of its software in the global
market place, <Company> consider it a low risk in line with ISPE GAMP5 Appendix M2
and therefore unnecessary to conduct a formal audit on the company in either USA or
Egypt at this stage.
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Validation Lifecycle
Below is the Validation Lifecycle Model adopted for the <site> Oracle OPM system.
PQP
Project Quality Plan
(Standards Applied)
VR
Validation
Report(s)
VMP
Validation Master
Plan
SOP
Risk Analysis
FS
Functional
Specification
Standard
Operating
Procedures
UAT
Training
User Acceptance
Testing
Combined
RA 1
RA 2
FT
Risk Analysis
Functional Testing
HDS
HAT
Hardware Design
Specification
Hardware Acceptance
Testing
SDS
SAT
System Design
Specification
System Acceptance
Testing
TESTING PHASE
(IQ\OQ\PQ)
URS
User Requirements
Specification
DESIGN PHASE
(DQ)
3.
Page No
CR
Code Review
The deliverables specified in the above model are covered in the following sections of this
plan. Deviations will be reported on within the Validation Report(s).
This section therefore defines the validation programme. The programme is divided into
phases according to the validation life cycle.
Each phase is divided into tasks and for every task there are actions, responsibilities and
associated procedures. The personnel identified, according to the procedures will
undertake the actions.
In the following tables R denotes prime responsibility for ensuring that a task is
completed according to the indicated procedure, and * denotes involvement with the task.
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The following roles are identified by the action plan:

PM:
USER:
ORC:
IT:
CV:
QA:
Project Management
User Representative(s)
Oracle Specialists and/or Oracle Project Manager
IT Specialist(s)
Computer Systems Validation Representative
Quality Assurance Representative(s)
Each activity should be conducted in accordance with a specified procedure from ISPE
GAMP 5[1], as appropriate.
3.1.
Design Phase
This phase covers planning and production of documentation required to support the
system.
Oracle documentation standards and\or internal <site> policies or procedures are
adopted, where appropriate.
3.1.1.
Validation Master Plan (VMP)

The VMP (this document) identifies key activities, roles and responsibilities.
Responsibility
Action
PM
USER
ORC
IT
CV
Prepare
R
3.1.2.
QA
Review
Approve
User Requirement Specification (URS)

The URS will consist of High-level User Requirements outlined listing GMP and Non GMP
within each Functional Business Area; it will be produced using ISPE GAMP 5 Appendix
D1 [1].
Oracle documentation standards referred to in RD030, BP080 and BP090 will be adopted
where appropriate.
Responsibility
Action
PM
USER
ORC
IT
CV
QA
Prepare
R
*
Review
Approve
*
*
R
*
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3.1.3.
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Functional Specification (FS)

The Functional Specification describes the core functions of the system.
Oracle documentation standards to support the functional deliverables of the system will
be adopted where appropriate , referring to BR030
Action
Prepare
PM
Review
Approve
3.1.4.
USER
Responsibility
ORC
IT
*
R
CV
*
QA
Hardware Design Specification (HDS)

This document will define the design of the Hardware including Network and any
Infrastructure requirements in order to support the system.
Action
Prepare
Review
PM
USER
*
Approve
3.1.5.
Responsibility
ORC
IT
R
CV
QA
System Design Specification (SDS)

Any bespoke developments, as part of the system or its interfaces to other systems, will
be documented in an appropriate SDS.
Oracle documentation standards to support development of specific deliverables of the
system for <site> will be adopted where appropriate. Referred to in MD050 and MD070 (if
appropriate)
Responsibility
Action
PM
USER
ORC
IT
CV
QA
Prepare
*
R
*
Review
Approve
*
*
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3.1.6.
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Code Review (CR)

This section will focus upon bespoke software developments, which will be subject to
Code Reviews and will focus on GMP critical bespoke developments
Action
Prepare
3.2.
PM
USER
Responsibility
ORC
IT
R
Review
Approve
CV
QA
Risk Management
Risk Management is defined as Risk Assessment plus Risk Control.
An effective FMEA risk based approach to elements of Design and Testing as per ISPE
GAMP 5 [1] will be adopted throughout.
<Company> risk assessment guide in place will be updated to include procedure for
Conducting a Failure Mode Effect Analysis as per ISPE GAMP5.
Results from the FMEA assessment will be utilised to focus validation-testing effort at a
sub-process level during implementation.
Each specific element identified is therefore assessed for its risk and its controlling
identifier and tested\checked accordingly.
Action
Prepare
PM
USER
*
Review
Approve
Responsibility
ORC
IT
CV
R
QA
A TRACEABILITY MATRIX for the URS>FS>SDS which also has GxP criticality will be
produced and refer to risks identified.
Particular reference to key regulatory requirements such as US FDA 21 CFR Part 11
covering Electronic Records, Electronic Signatures and recent proposed updates to EU
Directives 2003/94/EEC Annex 11 Computerised Systems will be taken into consideration
during the Risk Assessment process.
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3.3.
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Testing Phase
Specifications will be produced and testing conducted against them accordingly, in
conjunction with previously approved documentation specified in the Design Phase in
section 3.1
In addition, consideration will be given to aligning or combining tests (for example
Functional Testing or User Acceptance Testing) to the project methodology as specified in
the V-model diagram in section 3.
Installation Qualification (IQ) is a combination of Hardware and System Configuration
testing. Operational Qualification (OQ) is a combination of System design and Functional
testing. Performance Qualification will represent the User Acceptance Testing.
3.3.1.
System Acceptance Test Specification (SATS)

This section will cover all aspects of system acceptance testing and will be conducted in
accordance with test specifications (SATS) exclusively on bespoke developments defined
in the corresponding SDS document.
Test scripts within the SATS will refer to the details contained in the SDS document.
All bespoke developments, as part of the system or its interfaces to other systems,
deemed to be of a GxP critical nature or to have an impact on the GxP or regulatory
aspects of the system will be tested.
Action
Prepare
Review
PM
USER
R
*
Responsibility
ORC
IT
CV
*
QA
Approve
3.3.2.
Hardware Acceptance Test Specification (HATS)

This section will cover Hardware (and system software) acceptance tests will be
conducted in accordance with a test specification (HATS) against the details within the
HDS.
Responsibility
Action
PM
USER
ORC
IT
CV
QA
Prepare
R
*
Review
Approve
*
R
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3.3.3.
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Functional Test Specification (FTS)

Functional Testing will be conducted against Functional Specification(s) to challenge the
delivered functionality required by the Users.
Responsibility
Action
PM
USER
ORC
IT
CV
QA
Prepare
R
*
Review
Approve
3.3.4.
User Acceptance Test Specification (UATS)

User Acceptance Testing will verify that all requirements of the system have been met.
This will include Business Scenario Testing, where appropriate.
Responsibility
Action
PM
USER
ORC
IT
CV
QA
Prepare
R
*
*
Review
Approve
3.3.5.
Hardware Acceptance Testing (HAT)

Hardware Acceptance Testing verifies the installation of all computer systems and any
input/output links or interfaces.
Action
Prepare
Review
Approve
PM
USER
*
Responsibility
ORC
IT
R
CV
*
QA
R
*
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3.3.6.
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System Acceptance Testing (SAT)

System Acceptance Testing verifies all bespoke system software functions as specified.
Action
Prepare
PM
USER
Responsibility
ORC
IT
R
Review
CV
QA
Approve
3.3.7.
Functional Testing (FT)

Verifies that all core functionality of the system meets it specification.
Responsibility
Action
PM
USER
ORC
IT
CV
Prepare
R
*
*
Review
Approve
3.3.8.
QA
User Acceptance Testing (UAT)

Verifies that all business processes have been comprehensively tested and that relevant
SOPs are operational.
Responsibility
Action
PM
USER
ORC
IT
CV
QA
Prepare
R
*
*
Review
Approve
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3.3.9.
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Validation Reporting (VR)

There will be validation report for the project, which includes the validated status of the
system.
Responsibility
Action
PM
USER
ORC
IT
CV
QA
Prepare
R
4.
Review
Approve
*
R
On-going Operational Phase

The following elements will be assessed as part of the process that determines the ongoing validated status of the system:
4.1.
Maintenance Plan
The maintenance plan for the control of the system, data and supporting activities will be
created / reviewed.
4.2.
Change Management
Changes to the system will be conducted in accordance with <site> procedure reference
<SOP ref> which should include change control , patch management and configuration
management and will be subject to review.
4.3.
System Administration, Security and Access

All aspects of system administration including security and access to the system will be
conducted in accordance with a <site> defined procedure.
4.4.
System Backup, Restore and Archiving

All aspects of system backup, restore and archiving will be conducted in accordance with
<Site> procedure reference <SOP ref> and will be subject to review.
4.5.
Training and Operating

All users will be trained in accordance with <site> company requirements and training
records will be maintained as per requirements detailed in procedure reference <SOP
ref>.
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4.6.
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Incident , Deviation and CAPA Management

Any incident or deviation raised against Oracle OPM R12 functionalities will be conducted
in accordance with <site> procedure reference <SOP ref>.
Corrective and preventive actions (CAPA) will be conducted in accordance with <site>
procedure reference <SOP ref>
(if not exists : A procedure describes the corrective and preventive actions (CAPA)
system including a number of CAPA initiators such as incident management will be
identified and approved. )
4.7.
Performance Monitoring
All aspects of systems performance monitoring based on Key Performance Indicators
(KPIs) will be managed and monitored in accordance with <site> defined procedure.
5.
Periodic Reviews
SOPs and records, produced as a result of system use and support, will be audited on a
regular basis to evaluate the effectiveness of controlling procedures. Details of reviews will
be formally recorded and approved in accordance with procedure reference <sop ref> and
will be subject to review.
Documentation updates are covered within change control reference 4.2
6.
Glossary
Term
Definition
AIM
Application Implementation Method
CAPA
Corrective Action Preventive Action
CFR
Code of Federal Regulation
DQ
Design Qualification
EU
European Union
FMEA
Failure Mode and Effects Management
FS
Functional Specification
FDA
US Food and Drug Administration
FT
Functional Testing
FTS
Functional Test Specification
GAMP
Good Automated Manufacturing Practice
GMP
Good Practice Processes, which must ensure the safe

control of product. These are general processes
associated with the acquisition, conversion, shipment
and tracking of component materials and manufactured
items.
GxP
Good Practices, including Manufacturing etc.
HAT
Hardware Acceptance Testing
HATS
Hardware Acceptance Test Specification
IQ
Installation Qualification
ISPE
International Society of Pharmaceutical Engineering
KPI
Key Performance indicators
OPM
Oracle Process Manufacturing

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7.
Term
Definition
OQ
Operational Qualification
PQ
Performance Qualification
SAT
System Acceptance Testing
SDS
Software Design Specification
SOPs
Standard Operating Procedures
UAT
User Acceptance Testing
UATS
User Acceptance Test Specification
URS
User Requirements Specification
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Regulations and Guidelines

The following guidelines and regulatory requirements are taken into consideration:
[1]
ISPE GAMP 5. Good Automated Manufacturing Practice. Guide for Validation

of Automated Systems in Pharmaceutical Manufacture, Version 5.0 March
2008.
[2]
USA FDA 21 Code of Federal Regulation {CFR} Part 11, 1997.
[3]
USA FDA 21 Code of Federal Regulation {CFR} Parts 210 and 211 GMP.
[4]
2001/83/EC. Manufacture and Importation with European Directives

2003/94/EEC and 91/412/EEC laying down the principles and guidelines of
GMP
[5]
Egyptian Ministry of Health (MOH) regulation and authorities.
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Appendix A - Specific Project Roles, Responsibilities and Key Deliverables Table

The following key personnel have been identified:
Affiliation/Job
Title/Function
Project Manager
Quality Assurance
Computer System
Validation
Oracle
Information
Technology
Acronym
User
USER
Name
Responsibility
PM
QA
CSV
Project Manager and System Owner

Project Quality Assurance
Validation Project Manager
ORC
IT
Software Vendor
Validation Support Co-Ordinator
Validation Project Technical Support
Inventory
Purchasing
Planning
Quality Control
Production
You can add appendices from the project charter ,, like Project team and Gantt Chart

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<Company Name>

Oracle R12 e-Business Suite OPM Validation (Master) Plan

Oracle OPM for < Site >

Oracle R12 Process e-Business suite

Validation (Master) Plan

OPM Validation Master Plan

Oracle R12 e-Business Suite OPM Validation (Master) Plan

Oracle OPM for < Site >

Reason For Revision

OPM Validation Master Plan

Oracle R12 e-Business Suite OPM Validation (Master) Plan

Oracle OPM for < Site >

Vendor Status .................................................................................................... 6

Validation Lifecycle ........................................................................................... 7

Validation Master Plan (VMP) ........................................................................................ 8

Risk Management .............................................................................................. 10

System Acceptance Test Specification (SATS)............................................................ 11

On-going Operational Phase .......................................................................... 14

Periodic Reviews ............................................................................................. 15

Regulations and Guidelines ........................................................................... 16

Appendix A - Specific Project Roles, Responsibilities and Key Deliverables Table . 17

OPM Validation Master Plan

Oracle R12 e-Business Suite OPM Validation (Master) Plan

Oracle OPM for < Site >

*GAMP is a registered trademark of the ISPE www.ispe.org

OPM Validation Master Plan

Oracle R12 e-Business Suite OPM Validation (Master) Plan

Oracle OPM for < Site >

Business Process Architecture (BP)

OPM Validation Master Plan

Oracle R12 e-Business Suite OPM Validation (Master) Plan

Oracle OPM for < Site >

OPM Validation Master Plan

Oracle R12 e-Business Suite OPM Validation (Master) Plan

Oracle OPM for < Site >

OPM Validation Master Plan

Oracle R12 e-Business Suite OPM Validation (Master) Plan

Oracle OPM for < Site >

The following roles are identified by the action plan:

Validation Master Plan (VMP)

User Requirement Specification (URS)

OPM Validation Master Plan

Oracle R12 e-Business Suite OPM Validation (Master) Plan

Oracle OPM for < Site >

Functional Specification (FS)

Hardware Design Specification (HDS)

System Design Specification (SDS)

OPM Validation Master Plan

Oracle R12 e-Business Suite OPM Validation (Master) Plan

Oracle OPM for < Site >

Code Review (CR)

OPM Validation Master Plan

Oracle R12 e-Business Suite OPM Validation (Master) Plan

Oracle OPM for < Site >

System Acceptance Test Specification (SATS)

Hardware Acceptance Test Specification (HATS)

OPM Validation Master Plan

Oracle R12 e-Business Suite OPM Validation (Master) Plan

Oracle OPM for < Site >

Functional Test Specification (FTS)

User Acceptance Test Specification (UATS)

Hardware Acceptance Testing (HAT)

OPM Validation Master Plan