Managing biological agents and genetically modified organisms (GMOs)
Biological agents and genetically modified organisms (GMOs) play a central role in many scientific, medical, and industrial research institutions. Handling these substances involves risks and requires precise management to ensure compliance with applicable legal requirements. The eplas “Biological Agents” module is designed to provide responsible parties in research institutions, companies, and hospitals an efficient, legally compliant, and user-friendly solution.
What are biological agents and genetically modified organisms (GMOs)?
Biological agents are living microorganisms such as bacteria, viruses, fungi, or parasites that can cause disease in humans, animals, or plants. Their use in research and industry requires close monitoring and documentation, as handling these substances often involves health and environmental risks.
Genetically modified organisms (GMOs) are organisms whose genetic material has been altered in a way that would not be possible through natural reproduction alone. GMOs are used in many fields, including biomedical research and agriculture. Likewise, strict safety precautions are required to minimize potential risks to people and the environment.
How does the eplas module support the management of biological agents and GMOs?
This eplas module offers a comprehensive solution specifically designed for safety officers, biosafety managers, and decision-makers working in research institutions, hospitals, and companies. It supports the entire end-to-end process—from documentation to meeting legal requirements.
1. Creation of biological agent records
The eplas module enables structured, easy recording of all biological agents in use, including detailed information on the type, risk, and intended use of each agent.
2. Categories and classification
Biological agents can be assigned to risk categories as defined in by the German Biological Agents Ordinance (BioStoffV). This classification is essential for defining the appropriate protective measures.
3. Storage locations and inventory
Manage storage locations clearly and precisely. The module’s storage management provides an up-to-date overview of inventory and storage locations. A simple issue-and-return process ensures stock levels are always current.
4. Creation of a biological agents register
The module automatically generates a complete, on-demand biological-agents register. This simplifies documentation and ensures end-to-end traceability.
5. Risk assessments
The integrated risk assessment enables you to systematically identify potential risks and derive the necessary protective measures. It complies with the requirements of the German Biological Agents Ordinance (BioStoffV) and supports legally compliant documentation.
1. Creation and management of GMO data
The eplas module allows you to efficiently manage genetic engineering projects, including the GMOs involved and the associated facilities. The user interface (UI) makes it easy to capture and enter and categorize all relevant information.
2. Management of genetic engineering facilities
Manage the technical and facility requirements for genetic engineering facilities (containment areas). Create and administer facilities in a structured way, including relevant safety measures.
3. Management of qualified personnel and project leads
Assigning and managing responsibilities is a key aspect of GMO administration. The eplas module lets you create and assign competent persons, qualified personnel, and project leads for each genetic engineering project to ensure clear lines of responsibility and accountability.
4. Project management
The eplas module simplifies the management of genetic engineering projects. You can easily manage all projects, their associated GMOs, and the persons responsible, including tracking project progress and regulatory compliance.
5. Risk assessments
The module provides an integrated risk assessment for genetic engineering projects. This analysis of potential risks is essential for legally compliant handling of GMOs.
6. GMO register
The GMO register provides a complete overview of all GMOs used and the associated projects. It serves as a basis for regulatory inspections and audits and provides comprehensive documentation of all GMO-related activities.
7. Automatic creation of all required forms and documentation
The eplas module automates the creation of regulatory forms and reports needed for operating genetic engineering facilities and projects. This saves time and reduces the likelihood of documentation errors.
Why eplas®?
The eplas module for managing biological agents and genetically modified organisms was developed in close collaboration with leading research institutions. It is proven through long-term use and ensures the safe, legally compliant, and efficient management of biological agents and GMOs. Thanks to its modular architecture, the solution offers maximum flexibility and can be adapted to the specific needs of any organization. Benefit from our many years of expertise and our consistent compliance with all legal requirements.
