ABSTRACT

INTRODUCTION Many countries have now introduced regulations governing the use of electronic records, and the legal equivalence of electronic signatures to handwritten signatures. The basic requirements are based on established GxP expectations. Interpretation of the electronic record and signature regulations, and appropriate methods for achieving compliance has been subject to much debate and discussion in the industry. This chapter discusses the practicalities of compliance with U.S., EU, and Japanese regulations on electronic records/signatures and other principal international regulatory requirements and expectations. Topics covered include

l Practical definition of what constitutes an electronic record, l Audit trails for creation, modification, and deletion of electronic records, l Operational checks to verify authorized users, l Logical and physical security measure for access control, l Training for use of electronic records and electronic signatures, l Legal admissibility of electronic signatures, l Validation of procedural and technical controls, l Impact of applying a risk-based approach, and l Implications for electronic batch records.