Journals such as “Nature” or “PLOS One” have reported on studies with inadequately characterised or poor-quality biosamples, which often led to unreproducible research results [Simeon-Dubach et.al., Freedman et.al.]. As a result, numerous projects based on these research results – including those involved in drug development – were unusable and led to enormous time and financial losses.
A high quality of the biosamples and their associated data is essential to achieve reliable and reproducible scientific results. To ensure this, all sub-processes within a biobank such as acquisition, processing, storage and dispensing of biosamples must be thoroughly documented to be comprehensible in the long term. A sustainable quality assurance is a basic prerequisite for every biobank, which needs to be guaranteed by an implemented quality management system.