Pharmaceutical
Where reliability meets regulation
Pharmaceutical companies face mounting pressure to meet strict regulatory standards, manage rising R&D costs, and compete in a global market with shrinking drug exclusivity windows.
To stay ahead, they must deliver high-quality products while reducing risk, streamlining operations, and maintaining compliance with regulations from the FDA and CFR/GMP. Managing critical assets and validating processes across the product lifecycle are essential to ensure consistent performance, quality, and long-term value.
Streamline compliance
Gather data for all assets in one place, making it easier to comply with an alphabet soup of regulations and standards.
Protect product quality and patient safety
Reduce unwanted downtime and speed production by automatically scheduling proactive maintenance and calibration of mission-critical assets.
Accelerate transformation
Leverage our accelerators, knowledge of best practices, and use of process libraries to speed implementation. Expert training of your team helps ensure faster adoption.
Meet the challenges of FDA-regulated facilities
Consistent product quality and uninterrupted production start with reliable assets. In tightly regulated environments like pharmaceuticals, smart maintenance strategies help minimize downtime, reduce compliance risks, and keep operations audit-ready.
Navigate strict operational, legal, and regulatory guidelines, such as FDA 21CFR part 11 and ISO 9001, that must be adhered to for environmental, safety, and health issues.
Document and validate critical assets to meet Good Manufacturing Practices (GMP) and other industry standards.
Manage real–time changes to business processes, applications, data models, reports, and integration.
Improve operational excellence and performance of critical production (line) assets through proactive maintenance and calibration.
Reduce costs and achieve faster Return on Assets (ROA) by consolidating software applications relevant for managing all assets and their usage, performance, and availability. This includes Maximo Mobile, Calibration, HS&E, Scheduler, Spatial, etc.
Meet your drug production and packaging timelines by identifying potential issues earlier and reducing unplanned downtime.
QA is essential for drug manufacturing facilities. We can help you implement an EAM solution that automatically schedules and tracks calibration of machinery, helping to ensure equipment remains within specified tolerances.
Create and implement data governance solutions to maintain accurate, actionable information.
EAM Drives Safe and Scalable Services
A biopharmaceutical non-profit upgraded to Maximo Application Suite 9 to enhance asset management and meet strict regulatory and GMP compliance. TRM delivered automation, security, and performance improvements — 20% under budget.
Resources
Explore insights, guides, and tools designed to help you unlock greater asset management performance and business value.
500+
Maintenance and reliability assessments conducted
100M
Dollars in cumulative savings from improved reliability
29%
Average increase in measured reliability
5,000+
EAM implementations and integration projects
Unlock smarter
asset management
Ready to elevate your asset management?
Connect with TRM to start your journey toward
exceptional performance.
