Solutions

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

Software

With our PAS-X Manufacturing Execution System (MES) and 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

Handling

Handling

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

Inspection

Inspection

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

Packaging materials

Packaging materials

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 materials

Services

You need help with a specific product or have questions about one of our areas of expertise? Take advantage of our extensive range of services, we will support you quickly and easily.

All Services

Packaging materials

Packaging materials

The demands on pharmaceutical packaging are high: it should be forgery-proof and childproof, but also compact and sustainable. Find out here how we make packaging future-proof.

Overview Packaging materials Services

About us

We at Körber in the Pharmaceuticals business area are the people to contact when it comes to pharmaceutical products. As a leading system provider, we advise our customers from the development and production to the inspection and packaging of their products.

All about us

Christian Wölbeling

Blog

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.

Comments

No comments

Write comment

* These fields are required

Back to top
Back to top