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Service

Compliance Review & Labelling

SBP Toolbox as Starting Point

The SBP Toolbox is an innovative development with the primary goal to guide Swiss biobanks and biobank infrastructures on governance and quality management system related aspects following state of the art biobanking practices. An interactive tool that collects information about governance, regulatory compliance, business process, resources, quality management and information systems of a specific biobank (infrastructure). The SBP Toolbox allows calculating a score that serves as basis for the Label classification. A biobank or biobank infrastructure interested in obtaining a SBP Label completes as a first step the questionnaire in the SBP Toolbox; it is the starting point to determine the score and the Label class of this specific biobank (infrastructure).

Compliance Review — the Path

Before issuing a final Label, SBP performs a compliance review. This service is an effective and reliable tool to support the biobank’s quality management systems by proving them information on how to improve its performance. After having carried out the compliance review, SBP confirms the final score and issues the corresponding Label. It remains open to the biobank (infrastructure) to apply – by requesting another compliance review – for a superior Label at a later stage.

SBP Labels — the Achievement

Biobanks and biobank infrastructures have the opportunity to obtain a SBP Label depending on their legal and ethical compliance as well as compliance with international standards.

Label Vita is the entry point for any biobank or biobank infrastructure interested in joining the SBP network, i.e. a prerequisite to become an official member. SBP members can fully profit from the SBP services, increase their national and international visibility, and benefit from digital tools to manage and share biological resources.

SBP Label Class Determination
— Process Description

SBP checks Toolbox score

  • If Vita score is achieved, SBP performs a compliance review related to governance. Based on the outcome of the compliance review, the final score is confirmed. If score is sufficient, label Vita is determined.
  • If Norma score is achieved, SBP performs a compliance review related to the governance and the process management. Based on the outcome of the compliance review, the final score is confirmed. If score is sufficient, either Label Vita or Norma is determined.
  • If Optima score is achieved, SBP performs a compliance review related to the governance, the process management, and the quality management system. Based on the outcome of the compliance review, the final score is confirmed. If score is sufficient, either Label Vita, Norma or Optima is determined.
  • If score is insufficient, no Label can be determined.

Biobank / Biobank Infrastructure Compliance Review
— Process Description

SBP evaluates the governance (Label Vita), or the governance and the process management (Label Norma), or the governance, the process management, and the quality management system (Label Optima). SBP prepares a review plan and sends the proposal to the concerned biobank / biobank infrastructure. The biobank / biobank infrastructure evaluates the proposal and sends a confirmation to SBP (process stops in case of disapproval). SBP reviews the biobank / biobank infrastructure and writes a review report:

  • If biobank / biobank infrastructure is not compliant, SBP provides an action plan. Biobank / Biobank infrastructure implements corrective actions (back to start)
  • If biobank / biobank infrastructure is compliant, process stops
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