Change management in a QMS requires critical considerations that will make those changes sustainable and effective. When done right, modern change management creates a path to continual improvement that meets compliance requirements for FDA, ISO, internal quality control, customer requirements, and other regulatory bodies.

This AssurX whitepaper discusses and demonstrates how an electronic change management system efficiently manages change evaluation, planning, implementation, and documentation.

Key Focus Areas Include:

• Tapping the right resources to put changes into effect
• Using integration and automation functionalities to create a closed-loop system
• Leveraging a configurable change management system for business agility
• Incorporating risk-based thinking into a change management system
• Enabling compliance with built-in regulatory controls

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