Other Laboratory Operations
Food and Drug Administration
ORA Laboratory Manual Volume II, Section 2, ORA.LAB 5.10, defines the national procedures for reporting laboratory data. This document provides additional instructions for the preparation of analytical packages, including block-by-block directions for completing an Analyst Worksheet (FD-431 and FD-431a), and any associated documentation. It also describes laboratory protocols for recording observations and analytical findings in the web application, such as FACTS or LIMS, and the use of notebooks.