ECM for pharma­ceutical industry, med-tech and chemical industry

OPTIMAL SYSTEMS Bielefeld is specialized on quality manage­ment solutions – compliant with FDA and ISO 13485.
We also offer trusted solutions for invoice manage­ment, HR, customer- and contract 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.

Selected Customers

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.

Your heart beats digitally?
We are happy to receive your application!

We are looking for tinkerers, planners, visionaries – in short: go-getters who want to support our customers on their way to digitization. You don’t have to be an IT specialist, but simply a specialist in your own field – be it consulting, human resources, customer support or software development.

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

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.

Your Point of Contact in Bielefeld

Stephan Grande Portrait

Stephan Grande

Managing Director

Stephan Grande Portrait

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.