In recent years there has been an increasing need to automate many of the error-prone and time-consuming tasks such as inventory tracking, report generation, management of patient consent forms etc. As a growing number of software products target biorepositories, it is crucial that potential users have a standard against which to compare services. International standards ISO 17025 and ISO 15189 cover the operation of laboratories; NCI and OECD recommendations provide guidance for biological resource centers in general; ISBER best practices and the Council of Europe recommendation REC(2006)4 concern the treatment of human biological samples and research involving the use of such materials.
“We have published the guideline because we experienced an overwhelming need. The existing recommendations and standards are incomplete as they are aimed at analog handling. They only cover ethical, technical and management requirements of biobank samples. Alongside the analog handling, our guideline includes all-important software system requirements. These requirements are necessary to assure the dependable everyday workings of a well-run biobank.” said Dr. Zsolt Torok, Chief Scientific Officer at Astrid.
BioReq is intended to be used for the following purposes:
- As the basis for creating a custom Standard Operating Procedures (SOP) Manual: the requirements presented in this Guideline can be transformed into SOP statements. Using the Guideline as a basis of SOP guarantees that all relevant areas are covered.
- As a checklist of standards compliance: This Guideline incorporates ISO, OECD and NCI recommendations which apply to the operation of biorepositories. Since each requirement articulates a single recommendation which is either adhered to or not, there is no need for a separate audit checklist.
- To guide the design and development of Biobank Software Systems (BSS): software vendors can rely on this Guideline as an aid to guide product development.
- To evaluate BSS products: this Guideline can be used to evaluate the services of an existing BSS implementation, and compare the various BSS products available on the market.
An article has recently appeared about BioReq in Bioinformation with the title ‘Model requirements for Biobank Software Systems’. The guideline can be downloaded from http://bioreq.astridbio.com/bioreq_v2.0.pdf under a Creative Commons Attribution-NoDerivs 3.0 Unported License.
Headquartered in Vienna, Austria, Astrid is one of the largest bioinformatics/biobanking companies in Central and Eastern Europe. Astrid conducts extensive research and development activities to create software solutions for research institutions, university labs, pharmaceutical and biotech companies that are involved in preclinical genomic research. Astrid has created several biobanks and supports biobanking customers in software and data management at all levels. For more information visit: http://www.astridbio.com