Definition

A document that is formally managed with version control, approval workflows, and distribution tracking to ensure only current approved versions are in use.

Example

SOPs, safety data exchange agreements, and the PSMF are controlled documents. When updated, previous versions are archived and staff are trained on the new version.

Regulatory source

ICH E6, Quality Management

Common mistakes

Having unofficial working documents that circumvent the controlled document system, creating compliance gaps.

Inspector question

How do you manage controlled documents? Show me your document control system and version history.

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