ABSTRACT
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, have been subject to much debate and discussion in the industry. This chapter discusses the practicalities of compliance with U.S. 21 CFR Part 11 on electronic records/signatures and other principal international regulatory requirements and expectations. Topics covered include:
• Practical definition of what constitutes an electronic record • Audit trails for creation, modification, and deletion of electronic records • Operational checks to verify authorized users • Logical and physical security measure for access control • Training for use of electronic records and electronic signatures • Legal admissibility of electronic signatures • Integrity of biometric controls where they are applied • Validation of procedural and technical controls
ELECTRONIC RECORDS
Electronic records are defined here as those records used for GxP decision/review processes or regulatory submissions. Appendix 15A helps identify examples. Financial, Data Protection, and other non-GxP records held electronically may also have regulatory requirements, but these are not specifically covered here.
