Why do we ask to register to download the support documents?
Since early 2020, we ask our visitors to register to access the files we provide. The aim is to improve our support documentation by knowing who are our visitors and what they need. Login and registration forms are accessible through the links in the footer.
INTEGRATING THE CRITICAL SUCCESS FACTORS OF A BIOBANK
To support biobanks in the development of their Governance and Quality strategies, Swiss Biobanking Platform has developed the biobank SQAN, the biobank Solution for Quality Assessment and Normalization, an innovative web-based solution including the essential biobanking key components successful biobanks have to integrate.
Based on biobank’s answers, a score for each category (i.e. Governance, Processes & Resources, and QMS) is calculated.
What do these scores mean ?
The Governance management score shows the degree of compliance with the law and the respect of ethical considerations. It ensures that the biobank has a proper governance in place with trained personnel and a good management of regulatory requirements (e.g informed consent, EC approval, biobank regulation, Material Transfer Agreement (MTA) when applicable).
The Process and resource management score shows the degree of conformity of IT infrastructure, equipment monitoring, and premises control. It ensures a good management of biobank operational processes, (from the consent presentation to the shipment of samples). This part of the evaluation investigates the quality controls, and the validation of methods.
The Quality assurance management score shows the degree of effectiveness of the biobank Quality Management System, including documentation management, non-conformities management, risk management, and the implementation of appropriate preventive/corrective actions.
The compliance review allows SBP to propose customized supports and recommendations to biobanks according to the needs that were identified.
At the end of the process, labels can be awarded. They reflect the compliance level of the biobank with the minimal requirements set by SBP in terms of governance and quality.
Vita Label: Compliance with law and ethical standards
Norma Label: Standardization of the multiple biobanking processes from consent presentation to sample shipment, including personnel and equipment management
Optima Label: Optimization of the overall biobanking management system with focus on the implementation of quality assurance measures