Computer system validation (CSV) in Pharmaceutical Industry !! Introduction

Computerized
systems used in the various stages in pharmaceutical Industry.
In the modern era Automation / computerization is the become trend
or we can say necessity to achieve accuracy / precision in the various tasks. In
pharmaceutical Industry computerized systems are being used at various stages of Drug substance / Drug Product
manufacturing including Research and Development; Production, clinical trials,
Analytical Testing and Distribution of Drug substance / Drug Products and medical devices.

Fig. 1: Computer System Validation (CSV) Introduction

WHAT IS COMPUTER SYSTEM…..?

Computerized
systems include hardware, software, and firmware components
that must be validated throughout their lifecycle. When we talk about the Lifecycle approach then it involves the process right from design and
development to retirement phase. (i.e. End to End approach)

WHAT IS LIFE-CYCLE APPROACH FOR COMPUTER SYSTEM…..?

The lifecycle approach for computer system is defining
and performing the activities in a systematic way from conception,
understanding the requirements, via development phase and finally release the
system for operational use followed by system retirement.

According to GAMP® 5 guidelines there are four life cycle phases in a computer system
and each phase have a number of individual activities.

Concept – Includes a high-level
overview of the system and design considerations
Project – this phase includes detailed
description of the system and objectives
Operation – how the
system will be managed during operations
Retirement
– how to retire the system.

WHAT IS COMPUTER SYSTEM VALIDATION…..?

Computer
system validation (CSV) is a critical and important
process in the pharmaceutical industry that ensures that computerized systems used
in these functions are reliable, accurate, and comply with regulatory requirements.

CSV is the activity which is the part of Project Phase of computer system lifecycle approach.

It is a process which is implied to test, validate and
formally document that a regulated computer system does exactly what it is designed to do
in a consistent and accurate manner with data security, reliability and Traceability.

Fig. 2: Computer System Validation

WHAT IS OBJECTIVE OF COMPUTER SYSTEM VALIDATION?

The objective of CSV is to prevent errors, data loss,
data breaches, and regulatory violations that could be harmful for the desired
Quality and ultimately harmful to the patients. Considering the criticality and
its importance various regulatory bodies (including U.S. FDA, EMA and other national
regulatory bodies) enforced some requirements of CSV to ensure the safety and
efficacy of drug substance, drug products and medical devices.

The Process of Computer system validation (CSV) involves;

Creation of Validation Plan (i.e. Planning)
Testing and verification of system functionality
Execution (Validation protocol, validation report)
Performance

General Consideration

Documented evidence required to be generated at each
of these stages and must be reviewed and approved by qualified personnel, and
any discrepancies or issues must be addressed and resolved before the system
can be released for use.

The FDA defines;

Computer system validation as “a
documented process for assuring that a computer system does what it is designed
to do in a consistent and reproducible manner.” This means that the
computer system must be validated to ensure that it achieve the requirements of
its intended use, is reliable, and produces accurate and consistent results.

WHY TO VALIDATE COMPUTER SYSTEM?

The computerized systems that have an impact on
product quality, patient health, and good practices must be validated

To demonstrate that any procedure / process /
equipment / material handling activity or system actually performing accurately
and leads to the expected results.
To meet regulatory requirements
To ensure the integrity and traceability of
information and product quality

Failure to validate computer systems can result in
regulatory action, such as warning letters or product recalls, and can have
serious concerns for public health and safety.

This was a brief introduction to the computer system
and Computer system validation (CSV) Overall, CSV is a critical process to ensure
the safety and efficacy of drug substance / Drug products and medical devices during
its production, testing, and distribution, and complying with the regulatory
requirements in the pharmaceutical industry.

Learn More…………..

What is Validation study- Basic Overview?

Process Validation study- Types of validation
and advantage

Validation study: Why Three batch for validation
study?

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