• ECM in Regulated Environments
    Is a subject for Experts

    Experience makes all the difference: The OPTIMAL SYSTEMS site in Bielefeld and digital documents guide you along the path to digital quality management.

Digital Quality Management

Requirements for companies in regulated environments are constantly increasing. This affects the way in which documents, data, and processes are handled. It is no longer possible for anyone to maintain an overview of all the processes in this kind of company without high-performance software for document and process management.

Best practice solutions from the OPTIMAL SYSTEMS site in Bielefeld help you fulfill norms, guidelines, and statutory requirements, ranging from document control processes to processing complaints. At the same time, they optimize your process workflows, make it easier to work with documents, and boost the efficiency of your quality management.

For over ten years, OPTIMAL SYSTEMS Bielefeld has been offering solutions for perfect quality management in the pharmaceutical and medical technology sectors. These range from document control, technical documentation, and contract management, to incident processes and managing devices and test equipment.

Our enaio® best practice solutions are developed and maintained under GxP conditions. This guarantee the required data integrity and document history in an audit trail. OPTIMAL SYSTEMS also provides the complete document set for GAMP validation for all applications.

Glowing References Based on Years of Trust

Handling documents is a particularly sensitive affair for our customers.

That’s why we’re so proud that so many customers place their trust in us.


Customer since 2009


Customer since 2009

Max Zeller Söhne AG

Customer since 2013

Phoenix Pharmahandel

Customer since 2012

Ziehm Imaging GmbH

Customer since 2014

Bundesinstitut für Arzneimittel

Customer since 2004

  • The software from OPTIMAL SYSTEMS helps to optimize company-wide processes by structuring, standardizing, and thus simplifying them.

    Wolfgang Gleiniger
    Head of IT Applications
  • The ECM system was easy to implement in our company structure and culture, thanks to best practice solutions.

    Sebastian Koch
    IT Project Manager
    Ziehm Imaging

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Working Together

We’re searching for tinkerers, planners, and visionaries; in other words, movers and shakers interested in an exciting work environment and supporting our customers along their path to digitalization.

  • Taking on every challenge, creating a solution, and celebrating successes together: That’s how work should be!

    Content Manager
  • OPTIMAL SYSTEMS has a truly flat hierarchy.

    ECM Consultant
  • When I can do something better, the whole company and every single employee stand to benefit.

    Technical Trainer


Stephan Grande, who began engaging with process optimization during his studies, has been working in ECM solution sales since 2001. Prior to that, he worked in management and sales at various companies. He is a co-founder of the OPTIMAL SYSTEMS site in Bielefeld and since 2006, has been responsible for sales there. He became Managing Director in 2015.

Grande and his team specialize in the particular requirements of the pharmaceutical and medical technology sectors. Alongside classic ECM solutions, the company also provides various solutions for QM processes, thereby creating significant added value for customers.  

“We work at the intersection of the humanly possible and the technologically feasible. We can’t let that potential go to waste.”

Our Partners

Strong partners are the key to success. Thanks to our network of technology and solution partners, enaio® is used in all kinds of different scenarios.


itelligence AG

Insiders Technologies GmbH

IntraFind Software AG