Auditor Aponte utilizes a meticulous approach to inspection, prioritizing an in-depth review of documentary evidence related to equipment installation and operation, analytical testing, and training processes. There seems to be a strong correlation between procedural missteps, training issues, and out-of-specification results in her observations.

FDA auditor Marianela Aponte exhibits a strong interest in detailed, accurate documentation and procedural accuracy in both the installation, operation and validation of equipment and in ongoing laboratory testing activities. Aponte often focuses on the guidelines stated in USP chapters, indicating a preference for strict adherence to established industry standards. Additionally, Auditor Aponte seems acutely aware of training issues and tends to link analytical errors with a lack of effective training.