About the client
GxP-compliant Longterm Archiving at Formycon AG
Formycon AG is a leading, independent developer of high-quality bio-similars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities.
Formycon AG has partnered with biomedion GmbH to enhance their data integrity and process automation by implementing the BM-Watcher and BM-windream solutions across their laboratory environments. This project was driven by the need to meet stringent regulatory requirements, ensure seamless device integration, and establish a future-ready data management system.
Client
Formycon AG
Project Completion
April 2025
Solution Delivered
BM-Watcher 2.0.1.3
BM-windream 7.0
Objectives
> Deploy validated IT environments
for system operation
> Connect laboratory instruments
to centralized data systems
> Ensure Compliance
with regulatory standards and data integrity guidelines
> Enable Future Scalability
through detailed validation and documentation
> Empower Users
with comprehensive training and ongoing suppoert
Project Highlights
Seamless integration Across Lab Devices
> 25 laboratory devices were targeted for integration
> 22 devices successfully connected to the new system
> Custom modules developed to accomodate varying technical environments
Effective Collaboration
> Joint Formycon-biomedion team ensured close coordination
> Weekly and bi-weekly project meetings kept progress on track
> Rapid issue resolution and transparent communication throughout the project lifecycle
Robust Validation and Compliance
> Complete IQ, OQ and UAT conducted, meeting Formycon's high standards
> Extensive risk assessment and supplier evaluation were performed
> All installation and configuration processes meticulously documented
Tailored Training & Knowledge Transfer
> Detailed administrator and user training sessions delivered
> Training materials and recordings are made available for future reference
Seamless integration Across Lab Devices
> 25 laboratory devices were targeted for integration
> 22 devices successfully connected to the new system
> Custom modules developed to accomodate varying technical environments
Robust Validation and Compliance
> Complete IQ, OQ and UAT conducted, meeting Formycon's high standards
> Extensive risk assessment and supplier evaluation were performed
> All installation and configuration processes meticulously documented
Effective Collaboration
> Joint Formycon-biomedion team ensured close coordination
> Weekly and bi-weekly project meetings kept progress on track
> Rapid issue resolution and transparent communication throughout the project lifecycle
Tailored Training & Knowledge Transfer
> Detailed administrator and user training sessions delivered
> Training materials and recordings are made available for future reference
"The biomedion team showed strong commitment and flexibility during the project. Despite early challenges, their structured approach and collaborative efforts supported a smooth system implementation. The new system provides improved capabilities for managing our laboratory data."
Ivan Avila | Sr. Director Information and Business Technology | Formycon AG
Results and benefits for Formycon
Fully operational system
deployed within project scope
No open issues
or follow-up actions remaining
Enhanced compliance
and data integrity
More Business Cases
where Watcher and biomedion facilitate core processes
Raw data archiving in Drug Discovery
It is essential for compliance with Good Laboratory Practices regulations that a clear understanding of RAW DATA is established and maintained in laboratory records, as RAW DATA is found in various formats and versions in a large number of laboratory devices, LIMS, and quality management systems. Professional handling and full traceability of RAW DATA throughout its life cycle are crucial for lab control and overall compliance in the drug development process.
Optimizing Non-Clinical Development
The non-clinical development phase is an essential element of drug development, designed to identify which candidate therapy is likely to succeed and assess its safety before it comes to testing humans. Beginning in parallel with research activities, non-clinical testing is conducted throughout the entire development process in order to assess the drug's safety profile, pharmacokinetic and toxicokinetic characteristics.
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