We have a solution for everything – and the corresponding experience. In our current seven areas of expertise, we are at your disposal with our comprehensive know-how.

All Solutions

Software solutions

Software solutions

With our Werum PAS-X MES - on premise or cloud-based - and our software solutions for analysis, track & trace, networked factories, and intelligent packaging, we are the world's leading supplier and partner to the pharmaceutical and biotech industries.

Overview Software solutions

Handling systems

Handling systems

We are specialists for complete handling systems for pharmaceutical and medical products. Our solutions are decisive in the field of contactless and safe transport of e.g. glass syringes.

Overview Handling systems

Inspection machines


As the world's leading inspection expert, we develop solutions for the pharmaceutical and biotech industries. Our range of products extends from high-performance machines and semi-automatic machines to laboratory units and inspection applications for in-process control.

Overview Inspection

Machine finder

Packaging machines

Packaging machines

We are a leading supplier of packaging machines for liquid and solid pharmaceutical and medical products. With our blister, sachet and stick packaging machines we offer solutions for primary packaging. Our side and topload cartoners set standards worldwide for secondary packaging.

Overview Packaging machines

K.Pak Topload Case Packer

Introducing our latest solution from Körber; the K.Pak Topload Case Packer! Created specifically for the pharmaceutical industry, the K.Pak solution provides operator-friendly machines to complete any production line. Our solution focuses on innovative technology, high-quality design and expert handling and packaging of your product. It’s time to start connecting the dots with Körber!

Packaging solutions

Packaging solutions

As long-standing specialists, we develop packaging solutions for innovative and high-quality secondary pharmaceutical packaging made of cardboard. We offer you solutions for counterfeit protection, standard folding boxes and much more.

Overview Packaging solutions



Our experts will advise you during the analysis of your requirements, show you optimisation potential and support you during the implementation of projects in all areas of the pharmaceutical, biotech and medical device industry.

Overview Consulting


The role of MES for data integrity

To successfully transfer the process development based control strategy to the commercial production through technology transfer and scale-up, pharmaceutical and biopharmaceutical manufacturers need a best practice methodology. To ensure data integrity, this transfer has to follow a “Data Integrity by Design” approach applying process maps and process data maps. The goal is to create a flexible and robust production process with a well-documented lifecycle management. This result is also called production control strategy.

Data integrity is not a new regulatory requirement – inspectors are only looking more closely to what the industry is supposed to do. Relevant specifications are outlined for example in the FDA guidelines 21 CFR Part 11 and 21 CFR Part 211 and in the EU guidelines EudraLex Vol. 4 including Annex 11. This legislation is complemented by guidance documents issued by the MHRA, WHO, PIC/S, ISPE, and other regulatory bodies.

To successfully approach these issues pharmaceutical and biopharmaceutical manufacturers can rely on manufacturing execution systems (MES). The MES provides predefined data and process flows, which are executed by the right first time execution engine of an MES. The strict user guidance and the equipment interfaces are assuring that the data is defined and captured accurately according to the ALCOA+ principles. The data integrity will be designed in the Master Batch Records (MBR) management libraries. These libraries follow proven best practice approaches, are predesigned by the MES user community and come with MES content packages. Through its built-in data integrity an MES leads to a flexible and robust production control strategy assuring quality and compliance. This structured approach saves manufacturers time to market.


No comments

Write comment

* These fields are required

Back to top
Back to top