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 Customers 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.

  • Allergopharma

    Customer since 2009

  • MEDAC

    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, Allergopharma

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

Working together.

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

Accept every challenge, create a solution, and celebrate successes together – this is work as it should be.

Ludwig, Content Manager

OPTIMAL SYSTEMS: A flat hierarchy that is truly important to our company culture.

Markus, ECM Consultant

If I can do something more effectively, the whole company and every employee will benefit.

Joanna, Technical Trainer

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.

  • FRANKENRASTER GmbH

  • itelligence AG

  • Insiders Technologies GmbH

  • IntraFind Software AG

Your Point of Contact in Bielefeld

Günter Rodenkirchen

Head of Sales



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Stephan Grande

Management, OPTIMAL SYSTEMS Bielefeld

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.