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

Deep learning with Seidenader Eject-X

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

Consulting

Validation: Consistent and reproducible

Do you want to minimize your business risks, stabilize your manufacturing processes, and improve your product safety?

At Körber, we support you with a broad-based validation team. Our experts are at home in the pharmaceutical, biotechnology, and medical devices industry and are masters of both traditional and agile processes. The flexible validation services are user-oriented, efficient, and scalable to meet the requirements of any size company.

Pharmaceutical industry
Medical devices industry

lOur consulting services also extend beyond the validation services to cover strategic and organizational aspects of your areas of business.r

Stefan Münch, Business Director Validation & QM

Our validation consultants are experts when it comes to compliance with national and international guidelines.

We support you with all regulatory challenges, such as:

  • Risk management with a risk-based validation approach
  • Analysis of the Quality Management System (QMS) with regard to the validation processes
  • Creation of a validation plan as a definition of the project and validation strategy
  • Performance of Computer System Validation (CSV), including equipment and system qualification
  • GAMP®5 based solutions and use of the V-model or alternative procedures (further customer-specific compliance solutions are possible)
  • Creation of Standard Operating Procedures (SOPs) and training management
  • Consulting on data integrity
  • Complete audit management and support
  • Support for validation of the cloud solutions Infrastructure as a Service (laaS), Platform as a Service (PaaS), and Software as a Service (SaaS)

Our experts are happy to support you on-site!

We take on responsibility for the optimal progress of your project implementation with our extensive expertise, industry knowledge, practical orientation, and wide range of professional services.

We also support you with special expert knowledge for validation

Your advantages for the pharmaceutical and biotech industry

A perfect partner

We are specialists in the pharmaceutical validation area, with customers from small SMEs up to global players in the pharmaceutical industry’s top 10

Custom configurations

Scalable to meet the requirements of all company sizes

Individual adaptation

Customer-specific validation of the computer systems

Conformant regulations

Compliance with the regulatory requirements of national and international directives

Validation in the pharmaceutical and biotechnology industry

In summary: How we at Körber support you to unleash the full potential of your business.

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  • Evaluation and optimisation of the quality management system and technical documentation according to Medical Device Regulation (MDR) and Regulation (EU) 2017/745 on medical devices
  • Compliance Management Services in consideration of ISO 13485, FDA 21 CFR Part 820 and Part 11
  • Electronic Records / Electronic Signatures (ERES)
  • Audit management and support, e.g. as preparation for an MDSAP - Medical Device Single Audit Program

Your advantages for the medical devices industry

A perfect partner

We are specialists in the pharmaceutical validation area, with customers from small SMEs up to global players in the medical device industry’s top 10

Custom configurations

Scalable to meet the requirements of all company sizes

Individual adaptation

Customer-specific validation of the computer systems

Conformant regulations

Compliance with the regulatory requirements of national and international directives

To read up: The advantages of our validation service

Validation in the medical device industry

Managing regulatory requirements: How we can support you effectively.

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Case study Occlutech

Learn how the company Occlutech has benefited from our advice.

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About us

We are your contact when it has to do with pharmaceutical products. As a leading system supplier, we advise you on everything from development through manufacturing and inspection all the way to the packaging of your products.

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Our Team

We have already established ourselves on the market in the area of consulting at the start of the 2000s. In the two decades since then, we have been a fixed part of the pharmaceutical and biotechnology industry. Our consultants are experts for questions related to production in the regulated industry, and they find perfectly fitting solutions for your requirements.

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Any questions?

Get in contact with us. We’ll be happy to advise you about our solutions and services.

Get in contact

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