Case Study: Cook Medical achieves streamlined FDA compliance and faster reporting with Maintenance Connection

Streamlining FDA compliance with automated maintenance and reporting processes

Cook Medical, a Bloomington, Indiana–based medical device manufacturer with more than 16,000 products across 41 specialties and operations in 135 countries, faced inefficient, paper-based maintenance processes that made FDA compliance and audits slow and error-prone. With assets spread across the plant and thousands of products produced daily, technicians and compliance staff spent hours searching filing cabinets for maintenance records and work order status.

By implementing Accruent’s Maintenance Connection CMMS, Cook built a centralized asset database, automated preventive maintenance schedules and work orders, and enabled real-time reporting and digital calendars for staff scheduling. The solution validated equipment histories for FDA audits, cut reporting time by 3–4 hours, reduced downtime through proactive alerts, and improved overall compliance and operational efficiency.

Cook Medical

Mike McCormick

Maintenance Manager