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Electronic Records

Information created, modified, maintained, archived or retrieved in digital form as evidence of activities, decisions, results or fulfilment of requirements.

Related domain: ValidationConcept ID: concept-electronic-records

Definition

Information created, modified, maintained, archived or retrieved in digital form as evidence of activities, decisions, results or fulfilment of requirements.

Human Explanation

They are controlled records maintained in digital rather than paper form.

Why it Matters

Regulated records must remain trustworthy, integral, available and retrievable for the required period.

Conceptual Boundary

Not every computer file is a controlled Electronic Record; it must serve a defined evidential or documentation purpose and be governed accordingly.

Practical Perspective

Supporting systems should address access, change history, backup, Recovery and retention requirements.

Related Concepts