A record is a “snapshot” at a particular time for a particular purpose whereas data may be entered directly into a record for example spreadsheets, test results, etc or data may be retrieved from a database for example.

The integrity of the data is a direct reflection of the integrity of the record.

Data Integrity can be considered as the degree to which all data are complete, consistent and accurate, throughout the data lifecycle.

In order to apply the applicable regulations appropriately, the regulated user must understand the:

• Data Required
• Criticality of the Data to the Patient
• Collection System, Storage and Processing
• Risks of the e-Record Integrity
• Technical and Procedural Controls Required