Add to these the changing consumer and payer expectations we continue to see, and it has never been more important for pharmaceutical manufacturers to look more closely at asset maintenance and planning. It is critical not only for compliance and safety but also for overall success.

This means going far beyond eliminating paper processes. Instead, we need to look at transformative enterprise asset management (EAM), and that includes a comprehensive technology strategy that propels overall business improvements and meets international standards such as ISO 55000.

At an operational level, implementing an EAM system automates the identification, tracking, and location of physical assets. The system records maintenance as it happens, while also integrating with required—and often evolving— standards and protocols, recording and reporting on everything from calibration to electronic signoffs. This ensures an accurate audit trail and helps avoid the dreaded FDA 483 noncompliance letter, by providing access to real-time, easily verifiable documentation and data on cleaning, maintenance, and sanitizing that is demanded by 21CFR11.

Infor EAM helps pharmaceutical companies not only withstand regulatory scrutiny, but it also supports competitive advantage in an industry that is increasingly complex. EAM works to optimize equipment, facility, and fleet assets to ensure safe, efficient product delivery, and to monitor and scrutinize costs.

In working with some of the industry’s biggest players, we have seen Infor EAM help:

• Extend the asset lifecycle
• Increase equipment uptime
• Reduce the cost of compliance
• Consistently produce high-quality products
• Improve asset management to increase operational efficiency
• Uncover hidden profit potential to enhance your bottom-line performance
• Manage energy efficiency
• Avoid costly fines and plant shutdowns associated with compliance problems

These broad operational improvements are made easier through real-time tracking of inspections, materials, and labor costs. Workflows between equipment, systems, and locations are automated, with data captured at the point of maintenance. It also provides the framework for a preventive and prescriptive EAM culture, using asset performance analysis, alerts to potential issues, and centralized call center and work order management. Built natively for the cloud, Infor EAM for Pharmaceuticals is also fully mobile.

The pharmaceutical industry is one of the most scrutinized and publicly visible industries, and that is not going to change. Putting in place the right EAM technology that supports safety and reliability leaves businesses and leaders to dedicate the needed resources for continuous innovation and the pursuit of a healthier world.

Artículo original creado por Kevin Price, Product Strategist en Infor: https://www.infor.com/blog/facing-pharmaceuticals-industry-challenges-with-transformative-asset-management