Full-feature DMS solution
Content services in the cloud
Low-code/no-code ECM tool
Integration
AI components
Topics
Industries
- en
If you work in a regulated environment, you know the challenge: documents must not only be well organized – they must also be traceable, complete, and audit-proof at all times. At the same time, daily work should not become more complicated, but easier.
That’s exactly where we can help you.
For many years, we have been working with companies in the pharmaceutical and medical technology industries. We understand the everyday challenges – releases, changes, finding the right version, or handling unexpected audits. Our solutions address these issues directly – practical, intuitive, and designed to fit seamlessly into your processes.
Whether it’s SOPs, manufacturing instructions, or approval documents, our software helps you stay in control and ensures everything is exactly where it needs to be – with clear version control and a complete history.
Documents are created, reviewed, and approved in a structured workflow
All changes are controlled and fully traceable
Regulatory and quality documents are available at all times
This creates a system that eases your daily workload – and stands up to any audit.
Securely positioned – today and in the future
Reliability is essential in your industry. That’s why we consistently align with key standards such as GAMP5 and ISO 9001. For you, this means a solution that meets regulatory requirements while remaining flexible when processes or guidelines change.
More than 60 companies have successfully optimized their document management with us. Among them are regionally rooted mid-sized businesses as well as major corporations and renowned institutions.
INDICAL BIOSCIENCE
INDICAL BIOSCIENCE uses ECM for comprehensive document management. enaio® maps a file structure with various registers: documents, attachments, minutes, etc., are stored for each project.
At the same time, automated workflows in enaio® ensure that only valid documents are displayed – those that have successfully completed the required release processes.
Max Zeller Söhne AG
Max Zeller Söhne AG from Switzerland opted to digitize its approval documentation and SOP management. The goal here was greater efficiency through improved data access.
Implementing a custom-developed product database made it possible to manage country-specific product information more efficiently and streamline release processes.
Ziehm Imaging GmbH
Ziehm Imaging GmbH, a medical technology company based in Nuremberg, also relies on digital contract management with enaio®. This has significantly improved the ability to find documents.
At the same time, invoice processing integrated with the SAP system enables seamless workflows. The digitization of device history records (DHR) is already planned as the next step.
medac GmbH
medac GmbH is an excellent example of how our solutions can be used not only in specific areas of a company but virtually across the entire organization.
By introducing an “electronic memory,” paper documents in areas such as Change Control, CAPA, and Deviation have been largely replaced. This has significantly improved the flow of information between locations and departments.
As an industry specialist in regulated environments, the OPTIMAL SYSTEMS Bielefeld location provides the expertise needed to meet the challenges of the pharmaceutical and medical technology industries. We would be happy to present our solutions in detail and demonstrate how we implement quality management systems, change management, and integration with third-party systems. Your document management is in the best hands with us!
LOCATIONS