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Minimizing business risk, stabilising manufacturing processes and ensuring product safety? Computer system validation (CSV) plays a key role in the life science industry. It is designed to enable trouble-free processes.
Computer systems play an increasingly important role in the development and production of pharmaceuticals and medical devices. To ensure that all production, development and quality related processes run smoothly, Computer System Validation (CSV) provides proven standards.
What is Computer System Validation?
Computer System Validation (CSV) is a process used to test, validate and formally document that a regulated computerised system is operating correctly. In other words, validation verifies that the system is consistent and accurate, secure, reliable and traceable. In principle, validation covers both hardware and software.
The CSV process is used in many highly regulated industries, such as the pharmaceutical and medical device industries. In these sectors, computer systems are used to operate and record a range of processes and activities.
Importance of Computer System Validation
Part of the duty of pharmaceutical manufacturers is to ensure patient safety. This is the primary objective. However, ensuring product quality and data integrity is also part of the manufacturer’s specification. To achieve this, many complex specifications from national or international standards, laws and guidelines must be complied with. On the one hand, the extensive specifications mean high costs for the regulated companies – but at the same time, they also bring business benefits: Well defined and specified systems are easier to maintain, have less downtime and result in lower operating and maintenance costs. In addition, errors can often be detected earlier and operations can be continuously improved. It is therefore vital that the computer systems you use are reliable in their ability to:
- Capture data accurately and consistently
- Create an indelible electronic record
- Create a transparent, traceable and tamper-proof data trail
- Store all electronic records securely and permanently
Where is Computer System Validation used?
Computer System Validation (CSV) is applied to computerised GxP system applications used at any point in the research, clinical trial, manufacturing, distribution and storage process. Examples include:
- Laboratory Information Management System (LIMS).
- Laboratory Instrumentation Systems (LIS)
- Clinical Trial Monitoring Systems
Standards, Regulations and Guidelines
The requirements for validation are very high and extremely complex. There are strict national and international regulatory requirements that must be met throughout the system lifecycle. In the EU, medical device manufacturers are required to validate their software and systems. This is regulated in EudraLex Volume 4 Annex 11 on computerised systems. Validation of computerised systems is also required by ISO standard 13485 – for medical devices. Internationally, the Food and Drug Administration (FDA) provides detailed controls for electronic records and electronic signatures in the Code of Federal Regulations (CFR) at FDA 21 CFR 11. The FDA requires medical device manufacturers to validate software and systems used in the manufacture of medical devices in accordance with 21 CFR 820.
In practice, validation is usually carried out in accordance with GAMP. This is supported by many regulatory authorities and is now a globally recognised standard. GAMP stands for Good Automated Manufacturing Practice. It provides a pragmatic and practical guide to achieving a GxP compliant computerised system. The guide includes diverse and scalable validation approaches and strategies. However, GAMP is not a standard and therefore not mandatory.
Implementation of Computer System Validation
The process of computer system validation is time consuming and costly, but necessary to ensure data quality is secure and accurate. In practice, it requires highly skilled professionals, known as CSV specialists, to ensure that CSV is carried out efficiently and effectively. Among other things, they ensure a documented validation process that consistently and reproducibly demonstrates that a computerised system performs its processes as required. The entire validation process accompanies the entire lifecycle of the system, from requirements definition through operation to decommissioning. CSV specialists also develop frameworks for CSV according to GAMP guidelines and independently create a CSV master plan – just some of the many tasks performed by highly skilled knowledge workers in this environment.