RT Journal Article
SR Electronic
T1 Quality and Integrity of Data in Research, Development, and Innovation: A Risk Analysis Method Applied to Laboratory Notebooks in a University Pilot Plant
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 207
OP 216
DO 10.5731/pdajpst.2011.00673
VO 65
IS 3
A1 Anna Fàbregas-fernández
A1 Encarna García-Montoya
A1 Pilar Pérez-Lozano
A1 Josep MA Suñé-negre
A1 Josep Ramon Ticó
A1 Montserrat Miñarro
YR 2011
UL http://journal.pda.org/content/65/3/207.abstract
AB 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.