Time-Stamping

Definition

Time-stamping is the automatic recording of the exact date and time an action occurs within an electronic system, such as a data entry, approval, or signature. Accurate, system-generated time-stamping is a core data integrity requirement, since it establishes the contemporaneous nature of a record.

Benefits

System-generated time-stamps, synchronized to a controlled clock source, remove the risk of manually entered or backdated timestamps. A common data integrity concern regulators specifically look for and provide an objective, tamper-evident record of when an action truly occurred.

Use Case

An investigator reviewing a batch record notices an entry was made several hours after the associated production step reportedly occurred. Because the EBR system's time-stamps are automatically generated and cannot be manually edited, this discrepancy is immediately visible and prompts further investigation into the entry's contemporaneousness.

Frequently Asked Questions (FAQ)

Related Terms

• Audit Trail
• ALCOA / ALCOA+
• Data Integrity