From Paper To Performance: The Evolution Of EAM/CMMS In Pharma Manufacturing

It’s been over thirty years since the FDA introduced 21 CFR Part 11, a landmark regulation that opened the door for electronic recordkeeping in regulated industries. Despite this long-standing framework, many pharmaceutical manufacturers and contract development and manufacturing organizations (CDMOs) remain reliant on outdated, paper-based maintenance systems. These legacy approaches not only slow down operations but also introduce significant compliance risks and hinder the pace of innovation that modern manufacturing demands.

This white paper explores the pivotal milestones that have shaped digital transformation in pharmaceutical maintenance, from early adoption hurdles to the emergence of advanced, cloud-based solutions. It also confronts a critical question: why do so many teams continue to depend on systems that were never built to handle the complexity, speed, and regulatory rigor of today’s manufacturing environment?

If your organization is still navigating maintenance with paper logs and manual processes, it’s time to rethink your strategy.