How do paper records differ from electronic records in GLP validation?

• A. By standard for all critical data; electronic records are optional
• B. Paper records require continuous live access; electronic records do not
• C. Paper records are physical copies; electronic records require validation, security controls, and audit trails
• D. Paper records are validated automatically; electronic records do not need validation

Answer: (C)

In GLP validation, how records are handled hinges on protecting data integrity across formats. Paper records are physical documents that serve as originals when properly stored and retained; they exist as tangible copies and rely on proper handling, storage, and documentation to remain trustworthy.

Electronic records, on the other hand, must be validated and safeguarded to prove they are reliable and accurate throughout their life cycle. Validation shows the system does what it is intended to do and remains fit for purpose. Security controls limit who can access or modify data, preventing unauthorized changes. Audit trails record who made what changes and when, providing traceability and accountability for data history. These controls help ensure electronic records are trustworthy even as they are created, edited, and stored over time.

That’s why the statement that best captures the difference is that paper records are physical copies, while electronic records require validation, security controls, and audit trails. The other descriptions don’t reflect how GLP emphasizes validation and traceability for electronic systems, or they misrepresent the nature of access and validation requirements for paper versus electronic records.