Commentary provided by Claudia Kurreck (Department of Experimental Neurology, Charité -Universitätsmedizin Berlin, Germany)
The performance of audits and assessments is always a sensitive issue in the academic preclinical research environment. The most important argument for not conducting audits in the scientific community has been that audits would restrict the freedom of research; in the past, they were even perceived as inquisition. In this paper we describe that the opposite is true. Within six years, we were able to gain extensive experience with very different forms of audits and assessments within two different QM systems (ISO 9001 and PREMIER).
We investigate practicable options for auditing which have the potential to improve quality of preclinical research in academia, list specific recommendations regarding their benefits, and provide practical resources for their implementation.
We have been able to show that audits and assessments are an important quality assurance tool that can be performed without the existence of a QM system. In the process of our investigations, we have noticed a change in mentality regarding audits among our employees. Now audits are actively demanded instead of being strongly rejected, such as method audits to avoid protocol drifts.