Data Tracking and Trending
Trending is a regulatory requirement mandated by the FDA. A warning letter or FDA483 could be issued for not having a trending procedure. Out-of-specification result investigations continue to be one of the most commonly observed cGMP deficiencies during inspection of quality control laboratories.
Data trending / tracking is intended to be a proactive approach and therefore trends should be defined, identified timely and actions implemented. Maintaining a tracking log of OOS results, and having established procedures for investigating OOS results and providing user training on data tracking are critical due to potential public safety issues following release of non-conforming product. OOS related data resulting from analysis should be reported periodically and reviewed by the management to determine appropriate corrective actions.
We can help you manage OOS results which should include assessment of each individual case and the analysis of data for trends in order to detect potential problems and implement appropriate corrective and/or preventive actions.
We also offer SOP documentation services for: