What are key requirements for recording data to support integrity?

• A. Entries must be timely, legible, attributable; electronic records with audit trails are optional.
• B. Entries must be timely and legible.
• C. Timely, legible, attributable entries with electronic records having audit trails and secure access controls.
• D. Records may be handwritten without signatures.

Answer: (C)

Recording data with integrity means capturing information as it happens, in a way that others can read and trace back to the person who created or approved it. Timely entry reduces memory errors and ensures the data reflect what occurred. Legibility is essential so reviewers can understand the exact content without ambiguity. Attributable data ties the entry to a specific person, establishing accountability for what was recorded. When using electronic records, having an audit trail is crucial because it shows who accessed or changed the data and when, and secure access controls protect the data from unauthorized modification. Together, these requirements create a trustworthy, auditable record that supports GLP data integrity. Records that lack any of these elements—such as omitting attribution, lacking an audit trail, or permitting handwritten entries without proper signatures and controls—do not reliably support integrity.