Reporting and scheduling in-study inspections with the study director using microsoft Excel.

Abstract

Our Environmental and Metabolic Fate division conducts a variety of different studies that can require between 1 month and 3 years to complete. Our master schedule for this division can contain as many as 50-75 of these studies. Since the Good Laboratory Practices (GLP) regulations require in-study inspections at intervals adequate to assure study integrity and our quality assurance unit (QAU) standard operating procedure (SOP) requires us to monitor studies that last longer than 3 months at least once a quarter, in-study inspection scheduling can be challenging. In order to keep up with the work load described we have developed a method using a spreadsheet program, Excel, to facilitate in-study inspection scheduling through periodic reporting of all QAU inspection activity to the study director. This report makes the scheduling of critical phase and quarterly inspections a cooperative effort between the study director and QAU auditor. The details of the development and utilization of Excel for these "in-study inspection tracking reports" are presented.