What Is Computer System Validation And Why Is It Important?

Computer system validation is a software upgrading system that helps to keep your system up to date with modern times.

What is a computer system?

A computer is an electric hardware and software device which stores your information and data. A computer is made of CPU, memory, and its operating system. The working method of a computer is to store, retrieve, and process data. The computer has the capability of creating information or data and can store or output them.

You can also do many other entertaining things on a computer like typing, sending emails. Browsing on the internet, playing video games, listening to music, watching videos, and many more. A computer system has two main parts. They are hardware and software. 

Hardware means any part of the computer system which has a physical form like Keyboard, Mouse, Monitor, CPU. It comprehends all the things that have a physical structure you can touch including the internal parts of the device. 

Software is a program that is used in computers to run the system. For example games, web browsers, word processors, etc. The software instructs hardware when and what to do in the system.  

What is a computer system validation?

The main purpose of computer system validation is to do the software validation. A computer mainly organizes and run by software. So software validation is a must to keep your computer system updated. Validation is a process of updating your computer system with a valid set of defined system requirements.

It’s a critical system to ensure the quality of your computer’s performance. There is an advantage of the computer is to reduce the long term service and project costs. The validation of the computer system does-

Specify users’ requirements.
Define the functional requirements specs.
Create a validation plan.
Maintain all the system release data and information.

Who Needs Computer System Validation?

Computer system validation is a process where you can avoid all the expenses and business risks. Different high rated business companies need to validate their computer system. They legally enforce to do their computer validation system.

Pharmaceutical companies:

Many pharma companies developed in the USA needs to do their computer validation system if their company provides or produces drugs due to treatment purpose.

Storage and distribution providers:

Which companies store or distribute products like pharmaceuticals or biological cells and tissues are strictly resisted to complete their computer system validation. Otherwise, their work considers as criminal activities. And for this reason, they will have to bear a big amount of penalty.

Companies that sell biological:

A product made from therapeutic serum or any viruses and used for injury or vaccine can be a biological product. Companies containing these types of products need to validate their computer system immediately. 

Medical device distributors:

Our medical system uses many electric devices. These devices know as medical devices or instruments. Companies providing these machines have to finish their computer validation system on time due to security issues. 

How do you validate a system?

There is one type of method to validate your system called V-Model or V Diagram. This is a popular method used to validate a computer system through ISPE via GAMP-5. Here is a complete picture of the V-Model:

Computer System Validation

Validation Plan:

This step describes the whole process method of Computer System Validation. The total plan of a system that what validated and how long it will go on. It defines the deadline and the budget for the validation. It also breaks down all the roles and responsibilities of the validation and their time and monitoring maintenance. 

Defining Requirements Specification:

At this stage, it clarifies all the software and functions the system needs to validate. And it also describes how this can be used. This step comprises many critical situations like rules and regulations, safety, and operational requirements. 

Function Specification:

This document provides the details of the software working process according to the user’s need. This includes specific screens and reports on how they work and also logic and predictions of requirements on how passwords or audit trails should work.

Design Specification:

Here this step gives a dedicated look to the entire system via a professional design team. All the functions how they work and how they organize all the tasks with the rhythm of the previous step are designed here. This also includes all the technical issues of the software or system.

Configuring a System Build:

This step is all about building up the system with writing. You will develop your software by written configuration scripts that include unit testing and integration testing. 

IQ Tests:

Installation Qualification test which is known as the IQ test is to confirm the successful installation of the software or system. If the correct installation of the system in the user environment following the design specification has happened is confirmed by this test. 

OQ Test:

Operational Qualification Test which is called OQ test provides Functional or system updates. This test defines all the functional issues that if they are working accurately without any bugs or errors. 

PQ Tests:

The process of the system is working properly or not, testing this method is Performance Quality Test. This PQ test confirms the system’s performance. This test follows user-defined scenarios to know that the system performance is running well. OQ test and PQ test are quite similar. 


All the working process of this model are reviewed in this stage. The total validation report is written in this last step which is also called validation summary or system certification. The report indecision about the whole validation process in a brief discussion. 

Why is it important?

There are so many reasons for computer system validation. This validation process is mainly used for the products that have been made for patients. We can not take risks with our patient’s lives. That’s why it’s very important to validate the system regularly. The FDA codes of regulations mainly require computer system validation. Especially 21 CFR 11 needs the process for all FDA regulated industries. Four main reasons for validation are mentioned here-

  1. Safety: Due to patient safety with the medicines it’s very important to validate the system.
  2. Effectiveness: Software needs to detect the illness potentially without any mistakes. In order to detect the disease effectively, the system needs proper validation. 
  3. Accuracy: The whole information of the patients about their diseases must be accurate. The software controlling this information validated in time. 
  4. Integrity: Software must be allowed to detect the data if the data are false and to prevent deletion of the records. For this reason, the system has to validate. 

Benefits of Computer System Validation:

Computer system validation is a very good practice for any computer system. It keeps the system updated. For a pharmaceutical company, it’s a very supreme opportunity for an effective business. Due to validation, the company keeps the ability to provide all the required documents by FDA easily.

It increases the value of the computer system. There is one big advantage of the validation. It reduces the extra cost of labor to checking the validity manually. This process saves both money and time. And also it diminishes the risk of legacy and privacy policies. Overall it’s an effective, no-hassle method for computer systems. 


For health care companies computer system validation is a must. This provides a legally verified and effective system to give services. This validation system maintains all product quality in modern laboratories. It prevents projects from high expenses and works within a low budget with the regards of FDA.

The most important part is that a computer system validation will be effective when a professional team will look after the entire process of validation. A computer system validation can be fruitful financially.

1 Comment

  • thank you Students of Honours 3rd year BSC group from now find their result from nubd official website and our website also. National University’s authority published a notice today about Honours BSC
    nu result

Leave a Comment

19 − 12 =