Skip to content

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.

What exactly do we do?

  • Risk analysis of each new version
  • Monitoring new versions of serialization systems
  • E2E validation of serialization systems
  • Continuous revalidations of the serialization systems
  • Compliance of systems with applicable regulations

Other services:

Registrations

Registrations

We help our customers with registering the company and products in NMVO(s) and EMVO, gain access to national systems, and actively support drug verification from the IT perspective.

Learn more >>

IT system implementation

IT system implementation

We offer a range of services related to the implementation of information systems for drug serialization; starting from the system selection support, through implementation at all levels (L1-5), as well as integration with external systems.

Learn more >>

System administration

System administration

We manage the administration of serialization systems, user access, Master Data (MD), as well as reports and verification alerts.

Learn more >>

Customer Support/ Helpdesk

Customer Support/ Helpdesk

We offer customer support in the form of Tier 1 helpdesk. We agree on hours, languages and scope of support directly with customers. We also offer this service to customers for whom we have not implemented the serialization systems.

Learn more >>

Serialization management in drug supply chains

Serialization management in drug supply chains

We can communicate on behalf of our customers with their contractors, trade partners, national organizations. We support our customers not only with deep industry expertise, but also language skills.

Learn more >>
We are hAppy to help

Contact form