How is data integrity preserved in electronic data capture systems?

• A. Validation, access controls, audit trails, backups, and regular reconciliations with source data
• B. No validation
• C. Open access
• D. Only backups

Answer: (A)

Maintaining data integrity in electronic data capture systems means keeping data accurate, complete, consistent, and traceable from entry through analysis. Validation ensures what gets entered meets expected formats and ranges, preventing nonsense or erroneous values. Access controls restrict who can view or modify data, reducing the risk of unauthorized changes. Audit trails automatically log who accessed or changed data and when, providing a trail for investigations and regulatory review. Backups protect against loss from hardware failure or disasters, enabling recovery to a known good state. Regular reconciliations with source data compare the captured data to the original records (like source documents) to confirm there are no discrepancies and that data remain faithful to the source. Together, these controls create a robust, tamper-evident environment necessary for compliant data handling. The other options fall short because they omit essential safeguards: skipping validation allows bad data, open access invites unauthorized changes, and backups alone don’t prevent errors or ensure traceability.