Everything You Need to Know on Computer System Validation


Computer system validation increases the reliability of systems, resulting in fewer errors during processes. It also reduces long-term system and project costs by avoiding costly rework, maintenance, and data integrity issues.

FDA requires all regulated industries to validate software systems that touch products or generate, collect, analyze, transfer, or report data regulated by the FDA. 

Requirements Analysis

Requirement analysis is the first step in computer system validation and helps define what the system should be able to do. This process phase includes gathering user requirements, testing, and documenting the results of those tests.

In a highly regulated industry like life sciences manufacturing, CSV ensures that a new or existing computer-based system does precisely what it was designed to do consistently and accurately. It’s also essential to ensure that standard operating procedures are created and documented, along with any other documentation needed for the system.

CSV is a critical component of any pharmaceutical or medical device company that must meet FDA and other regulatory requirements. It’s also a requirement for companies that distribute medical devices used for diagnosis or treatment or that store biological products such as therapeutic serums and vaccines. These companies must follow the FDA’s Good Manufacturing Practices (GMP) norms for their systems.


Computer system validation (CSV) is a process that ensures that a regulated computerized system does what it is designed to do in a consistent and reproducible manner. It is a process performed in regulated industries worldwide to meet regulatory compliance and reasonable manufacturing practice requirements.

What is computer system validation ensures? CSV is an ongoing activity and a vital part of any GxP-compliant business. It involves planning, removing irrelevant and modifying essential aspects, test selection, defining acceptance criteria, and documentation services. It also includes a risk assessment and identifying the required controls.

The design phase is crucial to computer system validation, as it sets the foundation for the whole process. The design phase should ensure the system is fit for purpose and will comply with all applicable regulations. It should also address the intended use of the system. The test results should verify that the system is designed according to the User Requirements Specifications, while IQ testing verifies that the system’s installation meets those specifications. This will help to prevent problems and reduce the likelihood of unanticipated issues occurring during the testing, configuration, and implementation phases.


Computer configuration refers to how hardware and software components are arranged to form a system. It is a crucial phase of the computer system validation process as it helps ensure all components work well together to meet the user requirements identified in the design stage.

The configuration phase also includes evaluating and controlling all change requests, proposals, and their subsequent approval or disapproval. It is crucial to computer system validation because it helps document and control all changes.

Businesses operating in a GxP environment, like the pharmaceutical industry, have stringent computer system validation requirements. CSV helps reduce compliance risk, data integrity concerns, and business liability.


The testing phase is a crucial aspect of computer system validation. It is where you verify that the software functions as intended. It also confirms that the software follows user needs and proposed uses.

This is a vital aspect of computer system validation, especially for companies in the pharmaceutical industry. These industries depend highly on computers for clinical trials, research and development activities, and production and distribution processes. In addition, these companies must meet strict regulations set by the FDA and Global Healthcare Protection Organization inspections.

A validation plan helps guide the project and provides a roadmap for the team. It will identify the scope of the work, expected deliverables, resources, and budget. It will also outline timelines and milestones.

A validation V-Model is a common way to represent the testing process. The requirements and specifications document the design, while IQ, OQ, and PQ tests verify that the software complies with those specifications. This is a critical part of computer system validation and can help you avoid costly mistakes like this. This is one of the reasons it’s essential to get your CSV services from a professional company.


The documentation phase of computer system validation involves creating and maintaining all necessary documents that describe the computer system, including hardware and software. Documents include system boundary documents, validation plans, configuration specifications, and validation testing reports. Documents must be organized to make it easy for regulatory authorities to review them at any point during or after the system is in use.

During this phase, the company should also develop a data archiving and retirement plan that moves any old or unneeded data to a separate area for long-term storage. This step can help companies meet record retention requirements and avoid compliance issues.

The global computer system validation market is experiencing strong growth owing to the growing need for technology in regulated environments. For example, the pharmaceutical industry relies on computers to achieve an effective manufacturing process and record product data. This is essential to meet rigorous regulations in the pharma industry and comply with global healthcare protection organization inspections. Without computer system validation, a small error could have catastrophic consequences. The FDA requires regulated industries to validate their computer systems and associated procedures to minimize this risk.