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Specializing in solutions for quality management processes since 2006

OPTIMAL SYSTEMS Bielefeld – Company-wide digital solutions for businesses

enaio® - the enterprise-wide platform for your digital transformation

Since 2006, OPTIMAL SYSTEMS Vertriebsgesellschaft mbH in Bielefeld has been digitizing and optimizing processes across the entire company using the cross-industry platform enaio®.

In addition, the Bielefeld-based company has specialized in two areas:

Cross-industry best-practice solutions for quality management processes, as well as specialized solutions for regulated industries such as medical technology, pharmaceuticals, and chemicals, which are fully compliant with FDA and ISO 13485 requirements.

Efficient Quality Management with the enaio® ECM Platform

Our software solutions are based on the proven enaio® ECM platform and meet the highest quality standards. With the enaio® Best Practice Solutions©, we offer a comprehensive electronic quality management system (QMS) that has also been developed for GxP conditions.

Modular Structure ofenaio®

sqm modular design

Nearly 20 years of experience in

regulated environment

More than 2,700 satisfied customers
More than 600,000 users

Scope of services for our QMS solutions:

  • Document control (e.g., Quality Management Manual, technical documentation)
  • Management of deviations, changes, and CAPA processes
  • Ensuring data integrity
  • Complete traceability through audit trails
  • Archiving that complies with legal requirements and is audit-proof
  • Electronic signatures
  • Validation documentation (IQ, OQ, URS, FS) in accordance with GAMP guidelines, including

 

Take advantage of a comprehensive, audit-ready system to meet legal requirements and optimize your quality processes.

 

Digitization of business processes – preconfigured and proven in practice

In addition to quality management solutions, OPTIMAL SYSTEMS Bielefeld also offers best-practice solutions for business processes:

  • Invoice Processing
  • Contract Management
  • Human Resources
  • Customer Management 

 

These solutions are designed to deliver a quick return on investment (ROI) and can be flexibly tailored to your specific needs—making them ideal for both small and medium-sized businesses and large enterprises alike.

 

Faster implementation through best-practice solutions!

We develop solutions based on real-world requirements asenaio®best-practice solutions to ensure a quick return on investment (ROI). Of course, our solution modules can be customized to meet your specific needs. Even complex tasks, such as the implementation of GxP-compliant software, can be completed quickly thanks to our preconfiguredenaio® best-practice solutions.

Our enaio® best-practice solutions enable particularly rapid implementation—even for complex requirements such as the rollout of GxP-compliant software. Thanks to our field-proven modules, project timelines are significantly shortened, saving you money.

 

Support for the validation process (CSV)

Upon request, we can guide you through the entire GAMP validation process. Our experienced specialists will assist you in developing a Validation Master Plan and in creating and maintaining the associated validation documentation.