System validation and revalidation in the serialization process
One of the most important elements of GMP is a correct validation and continuous revalidation of systems used for the production and distribution of medicines. Ensuring that the system meets all customer expectations and specifications is key. Key due to the reliable functioning of the system and stability of production processes. System validation at the end of the implementation is necessary, but it is only the first step in the continuous process of maintaining the system in accordance with applicable regulations. Each system is upgraded, and new versions are implemented, in some cases even several times a year. This creates the need to monitor new system versions, document risk analysis, and formal revalidation.
Our services related to system validation and revalidation
JRC conducts continuous validation and monitoring compliance with regulations for the customers, and also supports the technical parts of the audits.