Document Change Control

Description

Procedure on document change control.  Required to review and approve controlled documents.

A good document change control procedure becomes the foundation of solid QA control system.  This SOP provides detailed instructions and the appropriate form to review, approve, and implement any/all controlled documents in a quality system, and of course, with the proper records.

This SOP is flexible enough to implement even electronic files (not simply paper documents) and when used with our 21 CFR Part 11 Interpretation, can become a cornerstone of a Part 11-compliant document control system.

Variants of this SOP have been used in large pharmaceutical corporations, medium-sized medical products companies, and even start-up medical device firms.