Computerized System Validation (CSV) refers to the process of verifying and assuring that computerized systems used in pharmaceutical manufacturing operate correctly as intended and consistently produce the expected results.
Quality assurance is an essential requirement in the pharmaceutical manufacturing field because the products directly impact people’s lives and health. Even minor quality issues can lead to serious health risks for patients. Therefore, the term validation has been used in the pharmaceutical industry. For example, assessment of temperature control and mixing time during the formulation process constitutes an essential part of this validation.
Today, computerized systems are integrated into all aspects of manufacturing, production control, and quality control. Issues such as system design flaws, misconfiguration, and programming errors can have a serious impact on the quality and safety of pharmaceutical products. The concept of Computerized System Validation (CSV) was introduced to mitigate these risks in advance. In other words, while traditional validation focuses on verifying manually performed processes, CSV focuses on validating processes that are automatically executed by computerized systems. Despite the difference in focus, the objective is the same: to ensure consistent quality.
In the pharmaceutical industry, products are manufactured under especially strict regulations. This is because pharmaceuticals directly affect human health and lives, and even the slightest flaw in the manufacturing process is unacceptable. Therefore, countries around the world enforce strict controls not only on operational processes but also on the computerized systems that support them in order to ensure the quality and safety of pharmaceutical products.
The following are representative regulations and guidelines.
Since these regulations and guidelines also have an impact on the import and export of products, domestic compliance alone is not sufficient. To distribute products globally, it is essential to implement CSV in accordance with the regulatory requirements of each country.
The computerized system subject to CSV refers not only to software and hardware alone, but to the entire series of processes in which they are used to conduct business operations. In other words, verification also covers connection to business operations, including how users interact with the system and what kinds of deliverables are produced.
Representative systems subject to CSV in pharmaceutical industry settings include:
GAMP5 divides the lifecycle of a computer system into the following four phases and provides guidelines for validation in each phase. The phases and their main activities are as follows:
One of the most common concerns regarding CSV is the question: Do all systems have to be validated to the same extent? As it turns out, this is not necessary.
The key concept here is the risk-based approach. This method determines the scope and depth of CSV based on the importance and risk level of the system and is strongly recommended in GAMP 5.
For example, it is natural that the level of CSV required for an auxiliary system that is not directly involved in the manufacturing process differs from that required for a core system responsible for product shipment decisions and manufacturing records. Attempting to uniformly validate all systems would lead to a significant increase in both time and cost.
Adding CSV support requires extensive expertise and experience in multiple specialized fields, including expertise in pharmaceutical field operations, IT and system construction, validation processes, and relevant laws and regulations. Therefore, when delivering manufacturing equipment and systems, vendor selection must be approached differently than in other industries.
When selecting a vendor based on CSV compatibility, it is essential not only to compare product features and prices but also to assess the vendor’s risk-based approach in accordance with GAMP 5 and determine how effectively they can support users' validation activities. In particular, the availability of documentation for IQ/OQ/PQ and the level of support for data integrity will play a crucial role in ensuring the introduction of a reliable system.
Please feel free to contact us with our extensive experience for GAMP5-compliant CSV support at the time of system implementation.