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.

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24/7 available for you: In our virtual showroom, we present our extensive portfolio and latest innovations. 

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.

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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

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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.

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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

Software

Creating PQRs/APRs with the help of Werum PAS-X Quality Reporting

Do you want to create quality reports quickly and easily, while minimizing risks to data integrity? Werum PAS-X Quality Reporting will enable you to automate your product quality reviews.

 

Product Quality Reviews (PQRs) and Annual Product Reviews (APRs) are still time-consuming and challenging obligations for companies in the pharmaceutical and biotech industries. Many employees from various departments are involved in the creation of PQRs/APRs – a repetitive, lengthy, and error-prone procedure. Much of the scheduled time is devoted to the manual collection, evaluation, and visualization of data and the creation of the PQR/APR report itself. This leaves less time for in-depth analyses and overall assessments of products and processes. 

Werum PAS-X Quality Reporting automates routine work steps and standardizes your PQR/APR process. With just a few clicks, you can create completely GMP-compliant quality reports including all the statistics – even for several locations, if required.

  • Up to 60% time savings: efficient and innovative reporting 
  • 100% data integrity: automated and validated data acquisition
  • 100% usability: intuitive and workflow-based user interfaces
  • 100% focus on the reporting requirements for the pharmaceutical and biotech industries
  • Optimized for PQR/APR automation and use cases with similar content

Werum PAS-X Quality Reporting eliminates all the time-consuming routine tasks for the creation of PQR/APR reports. That leaves you up to 60% more time for challenging value-added tasks which provide real benefits for patients and the company.

The European Commission has defined the requirements for the content and frequency of EU companies’ product quality reviews as part of the principles and guidelines for Good Manufacturing Practices (GMP). Part I of the EudraLex EU GMP Guidelines contains the PQR requirements for medicinal products approved for human and veterinary use, and Part II describes the scope of product quality reviews of active ingredients. The EU GMP Guidelines are virtually identical to the guidelines of the PIC/S, which now has more than 55 international inspection authorities as members. Pursuant to sections 211.180(e) and 211.192 of the CFR, the FDA requires an annual product review for products manufactured in the USA or imported into the country.

Werum PAS-X Quality Reporting fulfills both the European and the US GMP requirements. Our web-based software solution guides you in an intuitive and workflow-based manner through the process of PQR, APR or combined PQR/APR creation. The layout of the quality reports is based on flexibly configurable templates, of which the appearance and content can be adapted, e.g. on the basis of your company’s Standard Operating Procedures (SOPs). We also provide you with a preconfigured standard template, allowing you to work with PAS-X Quality Reporting even more efficiently. The content of this PQR template is based on an SOP that was created with the help of representatives from several pharmaceutical companies.

Free webinar

You can find out more in our free webinar titled "How to turn the obligation of quality reporting into an opportunity" , presented by Dr. Andreas König, Managing Director at Quality König GmbH, and Dr. Andree Ellert, Product Manager Software from the Körber Business Area Pharma.

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Your benefits

60% time savings

More time for challenging value-added tasks which provide real benefits for your patients and your company.

100% data integrity

Our standardized, fail-safe process ensures that you can have complete confidence in your data and easily put ALCOA+ into practice.

100% usability

Intuitive workflow-based user interfaces – our design experts guarantee a holistic user experience.

Do you want to automate your PQR/APR process?

We are looking for pilot customers who are interested in our new Werum PAS-X Quality Reporting software. You can participate in designing and developing the product. In return, you will be offered a free feasibility study and a one-year subscription at a 50% discount.

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Werum PAS-X Intelligence Suite

Make better decisions. With the solutions from our Werum PAS-X Intelligence Suite, you can collect, manage, analyze, and visualize your production data in a quick and easy manner.

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Werum PAS-X KPI

Every standstill in production raises questions about its root causes. Werum PAS-X KPI provides reliable answers for later analyses – thus boosting your Overall Equipment Effectiveness (OEE).

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Werum PAS-X Savvy

Manage, visualize, and analyze your process data with the help of Werum PAS-X Savvy – in real time and in a collaborative, intuitively usable software environment.

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Any questions?

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

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