Now that we’ve covered broader GMP issues in the previous 3 blogs, I want to discuss the overall role of an EAM/CMMS in managing compliance risks and some factors that come into play. In this blog and the upcoming blogs, we’ll cover purpose-built EAM/CMMS software, core compliance features and maintenance, calibration and validation functionality.
Managing Compliance Risks with EAM/CMMS Series
So far in this series, we covered recent FDA history and what to expect from the FDA in 2015. With the FDA’s risk based selection approach to conduct inspections, it is important to balance investment and compliance to drive overall product quality while maintaining productivity and profitability. For more information on Managing Compliance Risks with EAM/CMMS, view our recorded webinar.
First, I want to highlight the value of utilizing a purpose-built EAM/CMMS to manage ongoing compliance risks in your facilities. There are many full-feature and/or modular ERP systems that may provide asset management functionality. An all-encompassing ERP system is often sought out by corporate executives and while it may deliver a full view of an organization, it will not provide best in class maintenance and calibration functionality that drives compliance and productivity. End users will sacrifice specific features (we’ll cover in future blogs) that would have otherwise accompanied asset management software designed specifically for GMPs. It would also be significantly costly for companies to build work-arounds in ERP or generic EAM systems.
What is Purpose-Built?
By purpose built, I am referring to EAM/CMMSs that have been solely designed for GMPs. A purpose built system is developed from the ground up to serve the needs of the Life Sciences – starting with compliance. The future road map of any truly purpose-built software should also revolve entirely around the needs of the industry. The company outside of the product should understand the challenges of the industry and work to further study how they can improve their product to better meet their customers’ needs.
As a purpose-built EAM solution provider, Blue Mountain sees many Life Sciences companies moving away from generic EAM/CMMS and ERP modules to implement a truly purpose-built EAM, like Blue Mountain RAM. And, in order to meet the demands of corporate executives, they look to integrate functionality of the EAM/CMMS with ERPs.
Our next blog will cover the core compliance functionality of purpose-built EAMs.
For more information on Managing Compliance Risks with EAM/CMMS, view our recorded webinar.
Check out the other blogs in our Managing Compliance Risks with EAM/CMMS series:
- Managing Compliance Risks with EAM
- Focus on Quality Not Compliance: FDA’s New Office of Pharmaceutical Quality
- Monitor Quality with Metrics from EAM / CMMS
- EAM/CMMS Purpose Built for Life Sciences
- Core EAM/CMMS Functionality for Compliance
- Leveraging EAM Functionality to Manage Compliance Risks