Computer system validation is an essential process used in regulated industries. It ensures that both new and existing computer systems meet their intended purpose and consistently produce accurate data that enables regulatory compliance and fulfillment of user requirements. Validation is a requirement in most industrialized countries and a standard expectation worldwide. It reduces legal liability and improves overall business operations.
Scope of the Validation
In some cases, CSV can be life-saving – for example, it can detect medication defects that could otherwise cause unwanted side effects for drug consumers. But what is computer system validation? Computer System Validation (CSV) is an integral part of the quality assurance processes in regulated industries that impact patient health and safety. To validate a computer system, it is first necessary to identify the requirements. This step is known as characterization and determining the scope and strategy of the validation process. It can be done in several ways. For example, a high-level project plan can be created that includes vendors, costs, resource allocations, timelines and benefits, restrictions, and risks. A list of all the tasks that need to be accomplished can also be established at this stage.
The next step is determining what software needs to be used in the validation process. It is usually done by examining the system’s user needs and intended uses. A list of requirements and specifications can then be compiled for the software. It is important to understand that computer systems must be continuously monitored, tested and maintained. It’s true when there are updates to the hardware or software. Changes to these systems can cause the system to deviate from its validated state, resulting in errors that may not be immediately apparent.
Requirements
When a company decides to validate a computer system, the first step is defining what the system must do. It is called the requirements phase. It involves identifying user requirement specifications, designing the system and developing its documentation. It also involves creating test procedures and a Traceability Matrix. It is a crucial part of the process, and this must be done accurately and thoroughly. Once the requirements for a computer system are defined, a risk assessment is carried out to determine how serious the impact of any failures would be. It allows the company to understand which parts of the system are critical and what risks should be mitigated or avoided at all costs. Failures of computer systems can have a major impact on the production of pharmaceutical products and patient safety.
At this stage, a detailed project plan is drawn up with time and cost estimates and responsibilities are assigned to the different business departments involved in the validation process. The project manager coordinates the computer system validation and oversees the operation. The validation committee, which comprises people from the different departments involved in the process, should meet regularly to discuss progress and issues.
Methodology
Computer system validation is the process of testing, certifying and formally documenting that a regulated computer system does what it’s supposed to do in a secure, reliable and accurate manner. It is how regulated industries like pharmaceuticals, medical devices and cosmetics replace paper records, handwritten signatures and manual processes with electronic data and information systems. A comprehensive validation program is the best way to ensure that any regulated computer system works as intended. Controlled computer systems that affect product quality, safety and good manufacturing practices (GMP) must be validated. It includes systems that serve the production processes, storage of inputs and outputs, insurance quality, documentation management, record keeping and more.
Depending on the type of system, you can use a variety of methodologies to validate it. For example, you can follow the GAMP 5 Guide ISPE V Diagram, commonly used in the industry. This model begins with the Planning stage, then the System Build phase and ends with the Operating Qualification phase. It allows you to track the progress of each project, ensuring that all activities are completed and the results are documented. Moreover, you can also perform continuous validation studies to prove that updates to the hardware or software maintain the system’s validated state. It helps you avoid errors that “magically” appear after software upgrades or hardware changes.
Risks
Computer system validation involves identifying and quantifying the risks associated with a particular computer system. The risk assessment process includes analyzing the impact of potential damages or failures and developing methods to control them. It can be done in several ways. A common approach is brainstorming sessions where users, process and system owners, suppliers and subject matter experts can contribute their experience to determine the likelihood of damage or failure within a specific context. It can also be done using historical or statistical data to provide a basis for estimating the frequency of this type of damage or failure within a given context.
The responsibilities of the personnel involved in computer system validation must also be defined. The personnel must be trained and qualified to ensure that they will not introduce or transfer any viruses, worms or malware into the system. Additionally, they must be able to recognize and handle errors during data production. The steps involved in computer system validation are complex and vary depending on the nature of the system. For example, some systems may require developing a traceability matrix and creating an operational qualification plan. In contrast, others may need the result of a quality assurance manual. In addition, some systems may need to undergo a performance test protocol and PQ tests.
