Computer system validation process is described as the documented procedure which assures that a computer system performs the exact functions it is intended to reproducibly, consistently and verifiably. The computer system validation process covers every function and milestone of the computer system:

Development of the system

Operation of the system

The system’s maintenance

Its retirement

Archiving it

Documenting the computer system validation process is of critical importance, since this is what establishes that the computer system validation process is meeting its intended purpose.

The need for a computer system validation process

The computer system validation process is necessary for a number of important reasons:

The computer system validation process requirements

The organization carrying out the computer system validation process must do so keeping in mind its responsibility, which covers the following areas:

Standard Operating Procedures (SOPs)

Assessment of the inventory relating to the computer

Validation protocols that are specific to the system

Documentation of the validation protocols

In which areas is the computer system validation process necessary?

The computer system validation process is necessary to determine if the system requires to be validated for the following:

Computer system validation process relating to the hardware and software

The hardware and software are two important sections in which computer system validation process is needed. Good business practice requires that the organization designate a person entrusted with ensuring compliance with the computer system validation process for the hardware and software parts of a computer system.

Chalking up the Validation Master Plan

The computer system validation process gets crystallized into what is called the Validation Master Plan (VMP). This VMP consists of a plan to carry out the computer system validation process and includes:

Locating the set components during the validation process

Ranking and arranging the tasks according to their importance

Assigning responsibilities to the team

Identifying and forming procedures that are peculiar to the computer system validation process of the facility.

Steps for computer system validation process

The computer system validation process requires the following steps: