Case

Serialization

International compliance and full third-party integration are part of every delivery

When a global player in the pharmaceutical industry looks for a supplier to provide their serialization solution, it is not a task taken lightly. Especially when the company has production sites across Denmark, Hungary, China and the U.S, and the specification calls for a solution that can live up to every international standard in the book – as well as integration with a third-party site server and database.

When CIM Pharma was chosen to deliver just that, it was because the customer felt confident that CIM Pharma’s proven track-record in software development was what they needed to get the job done.

Robust integration for maximum OEE

“CIM Pharma is highly competent at integrating level three software with the reality of how the line is controlled – and this is no trivial piece of work to execute”, says Andy Cumming, head of Manufacture Change. Andy Cumming was an external consultant for the pharmaceutical company and co-responsible for the quality and success of the final solution. “Maintaining a perfect synchronization between the line controller and the database is of the essence in serialization, and CIM Pharma’s integration solution proved very robust. Seamless integration with other systems is one of the factors that keeps OEE high and reduces the total cost of ownership of a system – so that’s always crucial to customers”.

CIM Pharma delivered a complete serialization solution that:

  • Covered all levels of the packaging hierarchy: from product to carton to shipper to pallet
  • Was fully integrated and connected the relevant dataflows from level 1-4
  • Was ready for compliance with all international standards including CFR21 part 11
  • Included a complete documentation package including functional description, design description, IQ and OQ for validation
  • Was implemented, qualified, and validated by own system consultants

“CIM Pharma is highly competent at integrating level three software with the reality of how the line is controlled – and this is no trivial piece of work to execute.”

Andy Cumming
Consultant in Manufacture Change

Plug-and-play at all levels

“One of the key benefits of our solution is that we are able to integrate it with any existing site server, line controller or inspection system”, says Michel Seidelin, CEO of CIM Pharma. “Our standard solution is compatible with any printer or machine control out there, and it is based on pre-defined modules with minimal need for customization. In essence, we have a plug-and-play system that is easy to fit into any existing solution. It also means that we really don’t care who the other suppliers are – and in this case that was important since the customer had three different suppliers for machine control, serialization and inspection”.

“We are strong believers in simple, agnostic, yet robust software solutions”, says Michel Seidelin. “If you can make it easy to operate a complex serialization solution by using advanced software that builds on decades of experience – then why not do it?”

Do you want us to deliver a fully integrated and CFR21 part 11 compliant serialization solution for you? Get in touch now.

Anders Meister

CIM Pharma delivers plug-and-play technology for serialization and inspection in pharmaceutical production. We are born out of the software industry and create solutions that are compatible with any pre-existing system.
Contact
Jegstrupvej 96A
DK-8361 Hasselager
Denmark