AN IN-DEPTH EXPLORATION OF TITTLE 21 OF THE CODE OF FEDERAL REGULATIONS, PART 21: COMPREHENSIVE REGULATIONS GOVERNING ELECTRONIC RECORDS AND DIGITAL SIGNATURES

All Procedures are required to be fully documented and reported to regulatory authorities such as the U.S. Food and Drug Administration (FDA). The paper-based study records are increasing in size in order to document every single element as the criteria for documentation are continually increasing. However, the approach is to transfer the data to the database, but for every protocol, the specific database is required. Hence, at the moment, it hasn’t been feasible to develop generic electronic database that can be used for every single study to act as the source of documentation. They have devised a plan that involves using a user tool to document sources in a way that mirrors the advantages of traditional paper recordkeeping methods closely. Of paper documents we utilize tablet devices to store data, on servers using components and software. In our system setup we follow the regulations set by the US FDA for maintaining records. Our approach includes implementing a graphical source documentation technology that mimics the benefits of paper record keeping practices effectively. We use tablets of paper to store data, on servers in our system with components and software options available to us as, per the regulations established by the US FDA for managing electronic records.