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.

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