Production-specific line controller for traceability and product control in the pharmaceutical industry

Automation and digitalization of production, including the necessary quality assurance, is key to becoming the modern pharmaceutical company of tomorrow. Topics such as product liability and the certification and validation of production processes play a major role. As a result, all data relating to the production of pharmaceutical products has to be saved and securely archived. This includes not only data relating to the process, quality and production, but also data on manual random checks, access to machine control systems and recipe changes, which have so far been recorded mainly on paper and double-checked by a second person.

susietec® offers a comprehensive solution for digitizing data collection and work processes along the production lines. In addition to the certified hardware infrastructure consisting of KISS servers, HYG hygiene displays and IoT components for the local integration of field devices, the susietec® toolkit also includes the line controller software based on the FabEagle® series. All the services needed such as consulting, implementation, commissioning and validation are offered from a single source. In short: When implementing an efficient and reliable line controller for automated production sectors, pharmaceutical companies benefit from our know-how and many years of experience thanks to comprehensive consultation as well as a matched portfolio of hardware and software.

The susietec® products

  • FabEagle®LC
  • FabEagle®Connect
  • KISS Server
  • FlatView HYG Touch Panel


The service

  • Creating GMP-related specifications and documentation
  • Defining and implementing machine interfaces
  • Installing and configuring/customizing the line controller
  • Commissioning and supporting GMP validation


The challenge

  • ECreating GMP-certifiable interfaces and integrating production line machines
  • Digital mapping all quality-relevant workflows in the line controller
  • Collecting and storing all product data for individual parts at a production cycle rate
    of < 1 second
  • Implementing GMP project process and the necessary certification

The solution

  • Creating all GMP-relevant documents Selecting and implementing suitable software and hardware components
  • Mapping the product and line details
  • Discussing and implementing machine interfaces with machine manufacturers
  • Commissioning, documenting, testing and validating the overall solution


The result

  • Comprehensive line controller concept from a single source
  • Pre-qualification of hardware such as KISS servers and HYG hygiene displays in accordance with the required standards
  • Fast adaptation of quality assurance concepts to line details based on data that is automatically collected or manually entered
  • Simplification and acceleration of commissioning and GMP validation due to integrated approach
Production-specific line controller for traceability and product control in the pharmaceutical industry

Technical details fo the project

Line controller for fully automated production sectors within the pharmaceutical industry based on the combination of software, hardware, services and expert knowledge. The FabEagle®LC software used contains functions that are designed especially for the pharmaceutical industry, such as product configuration and data collection to enhance traceability, recipe management, quality data acquisition, and the mapping of dynamic user workflows such as sampling, changes being confirmed by a second person, and cyclical maintenance/tests that are adapted to the respective setup of the line.

The open integration platform FabEagle®Connect offers a large number of additional standard protocols for machine integration. Individual configuration based on the interfaces provided by each machine manufacturer enables secure and process-oriented communication.

The rollout of the matched software packages is generally virtualized on reliable KISS servers. If required, a distributed IoT infrastructure can be integrated using a K-BOX, which distributes the data load of the machine interfaces.

The entire implementation of the project, from defining the requirements to final commissioning and process qualification, is backed up and validated with qualifications and documents in accordance with GMP.


Advantages for the customer

The integrated approach, consisting of tried and tested hardware and service components, not only significantly
reduces the amount of work required for certification and qualification, but also relieves the customer of the task of
selecting and integrating individual components.

Instead of organizing and communicating with a large number of suppliers, the customer has a central contact person who provides advice and support while implementing the solution and all GMP environment processes. Project progress and time to market are accelerated while significantly reducing project risks at the same time. The result is a modern line controller solution that enables 100% paperless production even in the strictly regulated pharmaceutical environment.

Customer key figures

  • Reduce project time by 50 percent
  • Completely do away with manual documentation in paper form
  • Comprehensive product configuration and product data collection with fully integrated/fully automated production

Download PDF of Use Case

Your contact to our specialists for the susietec toolset

Do you have questions about the susietec® service portfolio or need support in the analysis, planning and implementation of your digitalization strategy?

The susietec® experts accompany you step by step on the way to the digital transformation of your company - customer-specific, solution-oriented, success-oriented. We look forward to hearing from you!

Please contact us
Stefan Eberhardt
Sales Specialist