Due to changes in the regulation of Genetically Modified Organisms (GMO) in the Netherlands there is a greater emphasis on keeping good records within institutions and companies. As of mid-2014 they are allowed to provide internal work licenses at the lowest levels, which entails that they are accountable for their internal policy to the responsible authorities. The Biosafety module provides an adequate registration of all GMOs and their precursors (hosts, vectors, inserts), as well as a log of the decision making process that is supported by a workflow. The registration goes beyond the statutory minimum so that researchers are facilitated in their daily work. The work with non-GMO biological materials is supported too.
A risk evaluation of a GMO experiment forms the core of the module. Due to the complexity of this process we’ve chosen for a decision support approach where all relevant background data (e.g. gene maps) and circumstances are shown to facilitate the researcher in taking the final decision.
The registration and admission control of all persons working in labs of a given containment level (risk class) is supported. Necessary instruction & testing and keeping records thereof is included in the workflow.
To be in compliance about 50 biosafety related business processes must be documented. The module supports storage and easy retrieval of all documents. A workflow robot alerts for the timely revision thereof.
- Register GMO, Hosts, Vectors, Inserts and Viruses with all details related to their functionality and safe use
- Register non-GMO biomaterials (e.g. animal and human tissue)
- Register governmental permits with listed organisms, users, labs and containment level
- Perform Risk Evaluation for GMO experiments including compliance check with actual permits
- Evaluate competences of new GMO users; offer applicable instruction & testing; control access
- Register all documents needed to be in compliance with governmental regulations