Computer system validation

Submitted to - Dr. Mymoona Akhtar
Submitted by – Shameer
Subject - PHARMACEUTICAL
VALIDATION (MPA 103T)
Course/year/sem – M.Pharm/1 yr./1
sem.
Session – 2020 - 2021

Introduction to
validation
Computer system
validation
FDA definition of CSV
Who needs CSV
How to do it
Benefits
References

Computer system validation
 What is computer system validation?
 Computer system validation (CVS) is often refers
to as software validation.
 By Rodrigo Perez dated 11/Apr./2018
 (regulated companies perform validation projects to
prove and ensure that their software or system is
performing the way it is supposed to work, and not
performing in ways that it isn’t intended to work.
 *FDA definition doesn’t sound like that*

As FDA do not take it so-lightly
it states
“Confirmation by examination and provision of objective evidence that
software specifications conform to user needs and intended uses, and
that the particular requirements implemented through software can be
consistently fulfilled”
General Principle Of Software Validation : Final Guidance For Industry
and FDA Staff

 Must have defined user
needs and intended uses.
 Examine the software to
confirm that it functions as
defined in the
requirements and that it
will be suitable for its
intended use.
 (The user can be a patient,
someone in the hospital, a
lab tech, a QA engineer, a
manufacturing person)

there must be defined
software requirements.
Document all validation
activities and test
results.

Examine the software to
ensure that it meets the user
needs and defined
requirements
This could include:-
 Design reviews
 Code reviews
 Testing, etc.
Define what the user needs
to do with the software and
how they will use the
software.

Confirm that the
requirements can be
consistently fulfilled (keep
in mind that not just in a
single situation).
This could include:-
 Stress testing multiple
data sets,
 Performance testing with
many users in many
locations,
 Testing with multiple
browsers or web apps,
 Testing from multiple
devices (and even mobile
apps), etc.
this Define how the
software needs to work to
enable the intended use.

 Need to have objective
evidence of this
confirmation ( this is done
for inspections).
 Document all validation
activities and test results
 The examination needs to
confirm that the software
will work in all anticipated
situations.

 Pharmaceutical companies. In the
US and most developed companies,
pharmaceutical businesses have to
undergo CSV. In particular, you need
to validate your system if your
business produces or distributes drugs
used for diagnosing or treating
diseases.
 Storage and distribution providers.
Businesses that store
pharmaceuticals, biological, or cell-
and-tissue products are obliged to
complete CSV. Otherwise, the
penalties might be as high as
debarment or a criminal prosecution.
 Products that sell biological. A
product can be defined
as biological if it’s made from a
therapeutic serum or a virus and used
for injury or disease prevention and
treatment. Vaccines are biological too.
 Medical devices distributors. By
definition, medical devices comprise of

 The classical V diagram is one of type methodology that is used for the
purpose of computer system validation
 The classic “V Diagram” was popularized by industry organizations
such as ISPE via GAMP Guides.

 A validation plane define the
approach and what to be
validated
 It define the role and
responsibilities along with the
acceptance criteria

The User Requirements
Specification describes what the
user needs from the software and
how they will use it. It also
contains any critical constraints
such as regulations, safety
requirements, operational
requirements, etc.
 System must track training of
lab analysts on lab
methods/techniques
 System must track samples
coming into the lab
 System must comply with 21
CFR 11

 The Functional Specification
document describes how the
software needs to work and look
to meet the user needs.
 The document might include
descriptions of how specific
screens and reports should
look, or describe data that
needs to be captured.
 For example, the Part 11
compliance requirements might
detail how passwords or the
audit trail should work.

The Design Specification document is
one that contains all of the technical
elements of the software or systems.
This includes:
 Database Design – file structures, field
definitions, data flow diagrams, entity
relationship diagrams
 Logic/Process Design – pseudo code
for logic and calculations
 Security Design – virus protection,
hacker protection
 Interface Design – what data will move
from one system to another; how and
how often, and failure handling
 Architecture Design – required
hardware, operating systems,
application versions, middleware, etc.
 Network Requirements
 Specific peripheral devices – scanners,
printers, etc.

 In the System Build step, you
develop or purchase your
software and then configure it to
the previous specification
documents.
 This step includes unit testing
and integration testing

 The Installation Qualification
tests provide confirmation that
the software or system is
installed and setup according to
the Design Specification.
 Usually the software is first
installed in a test or validation
environment, but there can be
exceptions in situations such as
manufacturing.

 Operational Qualification testing
is often referred to as Functional
Testing or System Testing.
 OQ tests confirm that all
functionality defined in the
Functional Specification is
present and working correctly,
and that there are no bugs.
 OQ tests can also include
confirmation of any design
elements not tested during IQ,
such as configuration, are
working as specified.

 Performance Qualification
testing is often called User
Acceptance testing. PQ testing
confirms that the software will
meet the users’ needs and is
suitable for their intended use,
as defined in the User
Requirements Specification.
 Testing can follow Use Cases,
SOPs, user-defined scenarios,
etc. For simple software like
reports or spreadsheets, OQ
and PQ testing are often
combined.

 The last step in this validation
method is to write the Validation
Report, often called the
Validation Summary or System
Certification.
 This report provides
confirmation that all activities
specified in the validation plan
have been completed.
 The Validation Report
summarizes the testing results
and provides confirmation that
all acceptance criteria have
been met and the software is
ready for deployment.

 Computer system validation helps
to ensure that both new and
existing computer systems
consistently fulfill their intended
purpose and produce accurate and
reliable results that enable
regulatory compliance, fulfillment
of user requirements, and the
ability to discern invalid and/or
altered records.
 CSV utilizes both static and
dynamic testing activities that are
conducted throughout the
software development lifecycle
(SDLC)

 www.astrixinc.com
 www.validationcenter.com
 www.pharmaguideline.com
 www.performancelabus.com
 www.wikipedia
 www.synopsys.com

Computer system validation

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