Complying With U.S. FDA Title 21 CFR Part 11 for the Life Sciences Industry


The purpose of this document is to describe the functions and features of SAP ERP that demonstrate technical compliance with U.S. FDA 21 CFR Part 11 Electronic Records; Electronic Signatures Final Rule and several international good manufacturing practice (GMP) guidelines having similar requirements. This document provides background information about the regulation, discusses how SAP ERP complies with this rule, and provides examples of electronic records and signatures within SAP ERP.