GMP Calibration Management

Pharmaceutical manufacturers are facing mounting pressure when it comes to calibration oversight, as regulatory scrutiny continues to intensify. Between 2023 and 2024, the number of FDA drug warning letters nearly doubled, with a growing emphasis on data integrity and maintenance failures. Despite this heightened regulatory environment, many companies still rely on generic enterprise asset management (EAM) systems that lack the specialized capabilities required for Good Manufacturing Practice (GMP) compliance. These systems often fall short in addressing the unique challenges of calibration management in regulated environments, which lead to costly deviations and compliance risks.

This white paper explores the limitations of generic EAM modules and highlights the hidden costs associated with calibration-linked deviations. It also presents a compelling case for adopting purpose-built solutions like Blue Mountain RAM, which offer pre-validated compliance features, faster deployment timelines, and measurable return on investment—especially for mid-size GMP operations.

If your organization is navigating the complexities of regulatory compliance and asset management, now is the time to consider a solution designed specifically for the pharmaceutical industry.