The U.S. FDA’s 21 CFR Part 11 was developed to allow the widest possible use of electronic technology in support of electronic record and electronic signature systems. While the use of electronic records is voluntary, an industry trend to move to paperless records is driven by the efficiencies of electronic media and the increased reliability and data integrity potential of electronic systems over manual processes. The rule was first issued in the spring of 1997. In 1998, the Building Technologies Division of Siemens Industry, Inc. delivered the first APOGEE® Compliance Solution designed to address compliance needs. The APOGEE Compliance Solution continues to evolve and with each revision, provides users with increased operational efficiency as well as a reduction in risk.