Quality and Integrity of Data in Research, Development, and Innovation: A Risk Analysis Method Applied to Laboratory Notebooks in a University Pilot Plant

Risk analysis tools can be applied in the early stages of the research, development, and innovation of pharmaceutical drugs. We used a risk ranking and filtering method to optimize time resources in internal audits of project development documents in order to ensure traceability in a university pilot plant. Data gathered during audits undertaken over a 14 month period were classified according to risk factors at several levels. Consequently, time resources for this type of internal audit can be optimised by focusing on aspects that are objectively determined to be critical to traceability. In addition, quality can be ensured by paying more attention to the most critical aspects, rather than the most commonly observed findings in historical data.Lay abstract One of the most important issue for a research, development, and innovation centre is the traceability of both experimental tasks and their documentation. This study describes an analysis of the findings revealed during internal audits carried out over a 14 month period, in order to establish its criticality and to highlight those important aspects to consider in future audits, while saving both personnel and time resources to carry out internal audits on development of projects.