CSV (Computerized System Validation) is a formalized process in industrial production to verify and document a regulated hardware or software how it meets a set of predefined end-user requirements and regulatory compliance. This approach ensures the equipment does exactly what it is designed to do in a consistent, traceable manner.
Whether it is about the implementation of a new computer system or just an upgrade of an existing one, validation is a mandatory part of the process. It is required in many industries, such as the production of food, beverages, medicine, vehicles or weapons.
The process of validation is throughout GxP-based, which means that Good Practices (documentation, engineering, manufacturing, clinical, etc.) are applied in each phase. Using all these approaches, patient health, product quality, and data integrity are ensured.
Documentation is crucial for validation activities. If any document is incomplete or deficient, an inspector (e.g. FDA, EMA) may prohibit the use of equipment in the manufacturing process. When an error is suspected to be more extensive, an entire production line can be shut down. It probably does not need to be emphasized that this can lead to the closure of a production site, the loss of multiple jobs, and the destruction of a pharmaceutical company's reputation.
Each validation phase in the pharmaceutical industry requires the expertise of a consultant who understands the relevant market regulations, GxP compliance, and equipment functionality. Imagine yourself about to undergo a complex surgery. Would you entrust your health to someone without formal education, proper surgical tools, or experience with advanced techniques? Now, you should understand why every piece of equipment used in pharmaceutical manufacturing must be validated, and why it is essential for a consultant to have knowledge required by a pharmaceutical company.
What is my role in CSV field? Depending on project and business needs I provide either consultation or execution of validation activities. This includes review and preparation of formal documents, in some cases participating in equipment qualification as well. In scope of the entire project, the following documents needs to be prepared or reviewed:
- System or security impact analysis (SIA);
- Risk analysis and assessment (e.g. FRA, LRA);
- User requirement specification (URS);
- Validation or qualification plans (VP, QP etc.);
- Design specification (e.g. HDS, SDS, FDS);
- Commissioning protocols (e.g. FAT, SAT) and test results;
- Qualification protocols (e.g. IQ, OQ, PQ) and test results;
- Change control management (CC);
- Validation or qualification reports and releases (VR, QR etc.).
