Computer System Validation, commonly known as CSV, is a documented process that can be used in the regulatory industry all over the world in order to cross-check that a computerized system performs exactly what is designed to do. This industry needs the process of computer system validation to confirm the exactness as well as the integrity of data in the computerized system with the aim to ensure the safety and effectiveness of the product.
In the United States, the Food and Drug Administration needs pharmaceutical companies in order to perform CSV that can support the production of the various products, including Blood and Blood Components, Pharmaceuticals, Biologicals, Infant Formulas, Human cell and tissue products, Medical Devices, and so on.
Computer System Validation is required when configuring a new system or making any changes in a validated system. The processes of CSV are usually based on applicable regulations as well as guidance, best practices for the domain, the features of the system are validated, and so on. This post helps you understand best practice recommendations for effective risk-based CSV assessment and testing. Let’s scroll down and read on:
When it comes to Computer System Validation, in a Food and Drug Administration regulated lab, a “computer system” includes computer hardware, software, and any equipment or instruments connected to the system along with users that operate the system and equipment with the help of Standard Operating Procedures and manuals. In addition to this, it ensures that both new and existing computer system meets their planned purpose and produce accurate as well as reliable results that enable regulatory compliance, meet the needs of users, and the ability to discern invalid or altered records. It uses static as well as dynamic testing activities that conduct throughout the software development lifecycle from system implementation to retirement.
According to the Food and Drug Administration, software validation can be defined as “Confirmation by examination and provision of impartial evidence that software specifications follow user needs as well as proposed uses, and that the precise requirements implemented through software can be consistently achieved.” Computer systems can be defined to confirm that the system will work accurately in every situation. Moreover, each validation activity and test result needs to be documented. All computer system validation activities should be documented along with:
- System inventory and assessment
- User requirement specifications
- Functional need specifications
- Validation Plan
- Network and Infrastructure qualification
- Validation Risk assessments
- Validation Traceability Matrix
- Operational Qualification Scripts and Results
- Performance Qualification Scripts and Results
- Installation Qualification Scripts and Results
- Validation Report
- System Release Documentation
In a nutshell, effective, accurate, and risk-based validation of computerized systems plays an important part when it comes to maintaining regulatory compliance as well as product quality in modern labs. Ineffective or inefficient computer system validation processes prevent projects from being delivered on time as well as within budget and can result in regulatory action. With regards to the Food and Drug Administration, for instance, regulatory action due to failure in order to perform accurate CSV can be legally as well as financially devastating to an organization.
If you have any questions about computer system validation or you are looking for consulting and outsourcing, simply get in touch with the right experts that hold years of consulting experience in the life science industry. You can use the internet to find the right service provider that can guarantee that these systems are running efficiently as well as accurately when you with them.
