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V Model & Validation Process-in
the Pharmaceutical Industry -
FDA Perspective
Applies to:
Any standard SAP R/3 System and Software Development Life Cycle (SDLC). For more information, visit the
Enterprise Resource Planning homepage.
Summary
The objective of this paper is share Conceptual clarity while working on Life science SAP projects ( End to
end, Solution Rollout, Development & Support etc) and try to take best practices out of this to other domain
projects. To bring the importance of Validation, Compliance from Quality System point of view.

Author: Girish Deshpande
Company: Satyam Computer Services Ltd
Created on: 30 December 2008
Author Bio
Girish Deshpande has worked in leading Automobile manufacturing for eight years in area of Quality
Assurance and has extensively worked as Senior Consultant in Quality Management, Plant Maintenance,
and Document Management System for global clients in Pharmaceuticals giants in Europe, Steel
Manufacturing units, Beverage bottler in China from eight years. The aim of this paper is to share V model &
validation in Pharma from FDA point of view.

V Model & Validation Process-in the Pharmaceutical Industry - FDA Perspective
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Table of Contents
Introduction ......................................................................................................................................................... 3
GxP Overview ..................................................................................................................................................... 3
Key Regulatory Bodies.................................................................................................................................... 3
What is CSV (Computer System Validation)................................................................................................... 4
V Model Concept ............................................................................................................................................. 6
Validation Process .......................................................................................................................................... 6
Document Tractability ..................................................................................................................................... 7
Conclusion .......................................................................................................................................................... 7
Related Content .................................................................................................................................................. 7
Disclaimer and Liability Notice ............................................................................................................................ 8

V Model & Validation Process-in the Pharmaceutical Industry - FDA Perspective
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Introduction
The primary aim of this article is to share key concepts while one work with Life science SAP projects in
particular to Pharmaceutical, Beverage, and Health care domain. Under stand and implement universally
formed model while executing projects. Following are key theme
 GxP overview
 Know Important Regulatory bodies
 V model
 Importance of Validation
 Document Tractability

As most of you know that entire Pharmaceutical Industry (Finished goods, Intermediate products, Drugs &
Substance manufacturing) deals with human & animal life, saving human. The pharmaceutical industry
undertakes the development, production and supply of pharmaceutical products needed to save lives,
prevent disease and otherwise assist in maintaining quality of life.
This industry is governed by Regulatory authorities and lot of emphasis on documentation. There is huge
Research & Development investment with long lead time for product to come into market for commercial
purpose once regulatory approvals are in place.
GxP Overview
The term GxP means GMP ( Good Manufacturing Practices) „x‟ includes
 GCP ( Good Clinical Practices )
 GLP ( Good Laboratory Practices )
 GDP ( Good Distribution Practices )

The pharmaceutical industry is regulated industry means pharmaceutical. Preparations must be safe and
effective for patients & the general public. It must protect consumer. Adhere to GxP for compliance & Proof
that any systems and activities are “fit for purpose”.
In nutshell the GMP covers all business functions which are closely associated with business process in
major category People who follow certain Processes to make required Products with the help of
administrative, Quality, regulatory Procedures & related paper work.
Key Regulatory Bodies
In major continents across globe, we have International reputed agencies who has worldwide presence who
acts as Regulated bodies for Pharmaceuticals industry
 Food & Drug Admirations (FDA) –Relevant for US Market mainly
 European Medicines Evaluation Agency (EMEA) –For European Region
 Drug Controller General of India –For India
Refer website for country specific regulatory bodies mentioned in reference.

V Model & Validation Process-in the Pharmaceutical Industry - FDA Perspective
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What is CSV (Computer System Validation)
 Computerized system validation (CSV) is the documented process of assuring that a computerized
system does exactly what it is designed to do in a consistent and reproducible manner.
 The validation process begins with the system proposal / requirements definition and continues until
system retirement and retention of the e-records based on regulatory rules.
 System definition artifacts that reflect these requirements can include, but are not limited to, the
following:
o User Requirements Specification: What the system needs to do for its user(s)?
o Functional Requirements Specification: How each feature of the system functions?
o Design Requirements Specification: How each feature of the system is built?
o Hardware Requirements Specification: Minimum hardware required to support the system.

FDA Definition: “Establishing documented evidence which provides a high degree of assurance that a
specific process will consistently produce a product meeting its pre-determined specifications and quality
attributes.” (Source: FDA Guidelines on General Principles of Process Validation, 1987)

Significance of CSV
Main business reason behind CSV is to deliver as per requirements and to have minimum maintenance cost
for a computer system. Documentation is one of the most important requirements of CSV. It is important for
Pharma Systems to be CSV compliant to:
 Minimize regulatory actions.
 Maintain positive relationship with regulatory bodies.
 Expediting submissions to FDA / other regulatory and faster approvals by FDA.
 Avoiding product recalls and negative publicity.

Key FAD Regulations applicable for SAP Projects
Following are key FDA Regulations which are closely related with SAP Software development cycle.
CFR : Code of Federal Regulations ,Title 21 mainly deals with Food & Drugs published by US FDA
 21 CFR Part 11 ( Electronic Records, Electronic Signature )*
 21 CFR Part 210 (Current GMP in Manufacturing, processing, packaging)
 21 CFR Part 211(Current GMP for finished pharmaceuticals)
* The 11 th sub part is related with all kinds of electronic records & Signature for software project
documentation.
V Model & Validation Process-in the Pharmaceutical Industry - FDA Perspective
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Audit trail of changes
 What type of changes ( Creation, Modification, deletion )
 What record was & what it is now
 Who did it ( Unique identities)
 When it was done

Electronic Signature
 Irrevocable legal signature
 2 Elements ( User ID and Password)
 Password not viewable ( even by system administration )

Access Control
 User Profile
 Password
 Password encryption

Main Benefits of 21 CFR Part 11 are
 Increased speed of information exchange
 Cost savings
 Reduced data entry and errors
 Improved process control
 More efficient data transmission to FDA for review and approvals

V Model & Validation Process-in the Pharmaceutical Industry - FDA Perspective
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V Model Concept
Below is Universally accepted model popularly known as V model The left arm of the V always deals with
defining the requirement and detailing the change and the right arm of the V ensure that for each item in the
left arm, There is a corresponding activity which verifies that the change done is as per the requirement,
design etc. Each Pharma company, IT Department, Implementation partner (System Integrator) makes its
tailored made Quality System to adhere to this. (both Verification and Validation process )


Validation Process
Definition: Confirmation by examination and provision of objective evidence that the particular requirements
for a specific intended use are fulfilled.
To ensure integrity, the system has to perform in a consistent manner and should give consistent
performance as expected. Validation of the system has to be done to ensure the system behaves in the
intended way as per the documented requirements.
Which Computer system should be validated
As a general rule computer systems used for or performing regulated operations should be
validated. These could include
 System used to control the quality of regulated products during various life cycle stages of the
product (development, testing, manufacture etc).
 Systems that create, modify, store, transmit regulated data such as product safety data, clinical trial
data, product efficacy data etc.
 Systems that maintain decision making data.
 Systems used to maintain data to be made available for agency inspection.
 Systems used to submit electronic records to the agency.

Validation Plan
System Build
Validation report
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Functional Specifications
Design Specifications
Operational Qualification
Installation Qualification
User Requirement Specifications Performance Qualification
V Model & Validation Process-in the Pharmaceutical Industry - FDA Perspective
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What is Qualification?
Organized efforts in project quality planning, Data Collection, documenting qualification plan and executing
qualification steps as per qualification plan. Finally reporting qualification results.
The major type of Qualification processes are
 Installation Qualification
 Operational Qualification
 Performance Qualification

Document Tractability
Documentation is a very important topic in the Pharma world, “In documentation we trust, everything
else is a rumor”. This is how the importance of documentation in validation could be stated. Documented
evidence of all the qualification activities is a must and these documents should follow documentation life
cycle described in the Documentation plan.
Traceability matrix simplifies the process of proving if and where the requirements or specifications are
tested, or conversely what each test case challenges. It is thus an aid to efficient test specification design. It
is a regulatory expectation that all requirements and specifications are demonstrably and appropriately
challenged, and traceability matrix is the best tool for achieving this.
 It is a must to record what is done and when it is done.
 Documentation should be able to gives complete end to end view of a drug history.
 Documentation helps in root cause analysis.
 Good documentation is a pre-requisite to achieve GxP.
 Documentation helps in achieving CAPA (Corrective Action – Preventive Action) schedules.
 It acts a Ready – Recokner
 Documentation is a key requirement for any compliance audits.

Conclusion
I assume that content of this paper will help most of reader to get more conceptual understanding with SAP
Project in Pharma, health care and other verticals to bring best practices from Life sciences. Your suggestion
are welcome for future improvement perspective.
Related Content
For more details please refer following reference material
http://www.pharmweb.net/pwmirror/pwk/pharmwebk.html (Country specific regulatory bodies)
http://www.fda.gov/ora/compliance (21 CFR Part 11: Electronic Records; Electronic Signatures)
www.fda.gov/ohrms/dockets/dockets/00d1538/00d-1538_c000031_03_vol7.pdf - 08-08-2002
(Guidance for industry 21 CFR Part 11; Electronic Records)
SAP White Paper “Complying with U.S. FDA Title 21 CFR Part 11 for the Life Sciences Industry”
For more information, visit the Enterprise Resource Planning homepage.

V Model & Validation Process-in the Pharmaceutical Industry - FDA Perspective
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Disclaimer and Liability Notice
This document may discuss sample coding or other information that does not include SAP official interfaces and therefore is not
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