Qbdgroup Com en Blog What Is The Gamp 5 V Model in Computeri

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What is the GAMP 5 V-model in

Computerized System
Validation?
 Yanis Soufyani, Life Science consultant at the QbD Group
 Software Services & Solutions  February 28, 2023
Want to introduce robustness into your software validation activities?

In this article, you will learn what the GAMP 5 V-model is and the key
steps within it.
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Using software for your life sciences operations requires high integrity and
security in the data processing. Your computer systems must be designed to
operate in a consistent and reproducible manner and comply with applicable
GxP regulations to ensure the expected nal product quality with certainty.
Validating your systems provides documented evidence that they do
exactly what they were designed to do.
Want to introduce robustness into your software validation activities? Then

you can use the V-model or the Agile approach. Both of these are Computer
System Validation (CSV) methods that can be applied according to GAMP 5 (the
industry guidance on how to validate automated manufacturing equipment
and computerized systems).
In this blog post, we will address the following questions:
What is the Agile approach?

What is the GAMP 5 V-model?
What are the main steps within the V-model?

Why use the V model?
Why use the V-model?
Enjoy reading!
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Agile approach VS GAMP 5 V-model
What is the agile approach in CSV?
The agile approach is based on a continuous exchange between the customer
and the validation team. The phases of the project rely on constant feedback
from the client to make progress and is an agile approach to achieve a system
that meets end-user expectations. With an agile approach, you have less
control over the overall budget and timelines for implementing an automated
system.
What is the GAMP 5 V-model in CSV?

Is managing time and budget important to your organization? If so, use
the GAMP 5 V-model. The V-model summarizes the key steps to be taken in
conjunction with associated deliverables within the context of computerized
systems validation or project lifecycle development.
The GAMP 5 V-model describes the activities to be performed and the

deliverables to be produced during product development. The name refers to
the shape of its common graphical representation: a V.
It is a variant of the Waterfall model of software development, which describes

a sequential procedure in which each step must be completed before the next
can be started. Since cycles are possible here, the V-shape appears.
Figure 1 – V-model scheme from the GAMP 5 guide
The GAMP 5 V-model strategy has a descending (planning, speci cation,

con guration) and ascending (con guration, veri cation, reporting) phase,
going back and forth from the customer to the supplier.
First, in the descending phase, input from the customer helps the
validation vendor implement the requirements at the bottom of the V-
model.
Then, in the ascending phase, the resulting development is compared to
the original input statement to verify that the customer’s requirements
have been met.
5 main steps of the GAMP 5 V-model

Each of the 5 main steps of the GAMP 5 V-model has di erent deliverables.
Let’s look at their purpose in detail below
1. Planning
The planning phase aims to de ne the strategy for validating the
computerized system. The strategy is essential and will be de ned in
the validation plan, but there are more deliverables than the validation
plan in the planning phase.
Validation project plan. Boundaries and interfaces are de ned

with the software scope, leading to a risk analysis to evaluate
criticality. To complete the description of the validation strategy, a
list of documents and responsibilities and a list of applicable
procedures, responsibilities, and required documentation are
created. Finally, tasks and roles are assigned to members of the
validation team.
Description of the system. In accordance with EU GMP Annex 11,
clause 4: “An up-to-date description of every GxP regulated
computerized system should be available.” Any authorized person,
new user, or auditor must have access to this information.
User Requirements Speci cations (URS). Users’ needs are
described from their point of view. They guide the development
activities and the functional controls that are implemented later.
Requirements can be categorized as operational, process,
regulatory, quality, performance, etc.
Risk analysis. Using common risk assessment techniques, risks
are identi ed, quali ed, and quanti ed to provide a response to
ultimately control them. Based on statistics, matrices are created
to determine risk classes by crossing severity and probability.
Priorities are then determined by crossing risk classes and
Priorities are then determined by crossing risk classes and
detectability.
2. Speci cation
The user requirements speci cations, which correspond to the end
users’ expectations of the computerized system, are translated into
functions, system interfaces, and system descriptions.
To ensure traceability between user requirements, functions,

con gurations, and later test activities, a traceability matrix is
required to establish the link between user requirements speci cations
and functional, design, con guration, and unit speci cations.
Such a matrix considers both the hardware and software sides.

References are given to procedures (e.g.: SOP and change controls) and
the criticality of the requirements.
3. Con guration/coding
This is the step in which the supplier relies on its expertise to
implement the customer’s requirements. All functionalities
documented in the previous steps are implemented.
4. Veri cation
According to the test procedure, the results in the test reports are
obtained from the previously performed con guration/coding. They are
compared with the expected values from the speci cations.
Veri cation tests consist of
unit and integration testing (integration quali cation, IQ: the

system is built as intended);
functional testing (operational quali cation, OQ: the system
works as intended).
as well as user acceptance testing (process quali cation, PQ: the
systems meet users’ needs).
5. Reporting
The validation report is a summary of the previous results and
activities of the project. It is the nal documented evidence that the
automated system has been validated.
Furthermore, all types of events that occur during the validation

process are documented. This includes scope changes, references to
the vendor review, a list of various activities, deliverables, deviations
and corrective actions, statements: “Fit for intended use,” training, and
others.
Why use the GAMP 5 V-model?

We started by explaining the main di erences between the Agile approach and
the GAMP 5 V model Both approaches have their strengths and pitfalls but
the GAMP 5 V-model. Both approaches have their strengths and pitfalls, but
summarized below are the advantages of a V-model approach:
Design that meets end-user expectations of

User Requirement Speci cations (URS)
End users clearly de ne their needs in a URS document approved by
the parties involved (users, validation team, quality assurance). There is
always an opportunity to modify them, preferably early in development
to save costs.
Quality & Compliance

The V-model approach relies on documented steps, either
requirements (URS) or development and validation (Unit & Integration
Testing, Functional Testing, User Acceptance Testing,). This ensures a
high level of data integrity.
Project planning. Manpower and time are easily managed as each step
has a predetermined duration.
Reliability
In the descending phase of the V-model, testing is done gradually until
development. Together with the control of the ascending phase, any
errors can thus be easily detected and corrected.
In conclusion, why would you opt for
the GAMP 5 V-model?
Does your software need validation for a speci c activity? The V-model of CSV
can be an approach, which will help you to ensure:
Goal, scope, and limitations of software use are de ned

Little to no place is made for mistakes
Tied budget
Data integrity related to patient health security
Do you wish to implement a V-model validation process within your company?

Our experts in QbD will be happy to help you! Please do not hesitate to
contact us.
Expert knowledge in Computer Systems

Validation
Our validation solution guarantees maximum return on investment.
Check our o -the-shelf validation solution for you.
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Life Sciences Insights

Sharing expert knowledge via our latest blog posts

What is the GAMP 5 V-model in

Want to introduce robustness into your software validation activities?

Want to introduce robustness into your software validation activities? Then

In this blog post, we will address the following questions:

What is the Agile approach?

What are the main steps within the V-model?

A complete guide to Computer System Validation

What is the GAMP 5 V-model in CSV?

The GAMP 5 V-model describes the activities to be performed and the

It is a variant of the Waterfall model of software development, which describes

The GAMP 5 V-model strategy has a descending (planning, speci cation,

5 main steps of the GAMP 5 V-model

Validation project plan. Boundaries and interfaces are de ned

To ensure traceability between user requirements, functions,

Such a matrix considers both the hardware and software sides.

Veri cation tests consist of

unit and integration testing (integration quali cation, IQ: the

Furthermore, all types of events that occur during the validation

Why use the GAMP 5 V-model?

Design that meets end-user expectations of

Quality & Compliance

Goal, scope, and limitations of software use are de ned

Do you wish to implement a V-model validation process within your company?

Expert knowledge in Computer Systems

ICH Q2(R2) Validation of Analytical Procedures: An Overview of the

Qualifying a New GMP Facility: From Pitfalls to Best Practices

Mastering Cleanroom Quali cation: navigating the latest regulatory

Subscribe to the Blog

Read more experts content

Stay up to date with life

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