Case Study

Improving Documentation Change Control Process

Source: CRB

By Niranjan Kulkarni, Ph.D., Director of Operations Improvement CRB, Boston, MA

Improving Documentation Change Control Process

In regulated environments, companies are expected to establish procedures for document change control as a way of ensuring product quality and safety. Any changes made to the product, system or facility, (e.g., manufacturing, processing, quality assurance/quality control, information technology (IT), etc.) need to be documented in a timely manner. Changing existing or creating new documentation typically involves multiple disciplines and can have long lead times.