ELM-154-03

How Legible Applies to CSV – ALCOA+ [Video]

To recap, legible is defined as data that is permanent and easily read by a human.

Design Considerations

Perform a risk assessment prior to implementation to determine the level of risk and the level of verification required

Vendor documentation includes the specific post-installation attributes of the system that must exist to meet the requirements.

Verification Considerations

Avoid record annotation tools that obscure data display and print should be avoided.

Test that records and report outputs are the same as that on-screen or originally entered (meta-data).

Best Practices

Implement SOPs to identify the importance of data integrity and define procedural controls to ensure no data is obscured during use or output.

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP