Executive Summary
Transitioning to a digital Quality Management System is essential for GxP compliance. Yet, industry studies show that over 50% of QMS implementations fail to meet operational timelines or exceed budgets. This analysis evaluates QMS project failures, focusing on over-customization, system validation bottlenecks, and user resistance.
Root Causes of Failure
- Over-Customization: Trying to custom-code every historical paper workflow makes the validation effort extensive.
- User Interface Friction: Heavy, complex forms cause shop floor operators to delay entry, leading to compliance backlogs.