In the previous blog, I discussed the importance of using purpose-built software. Because we are a purpose-built EAM solution provider, we see many Life Sciences companies moving away from generic EAM/CMMSs and ERP modules to implement a truly purpose-built EAM, like Blue Mountain RAM. One of the biggest values of utilizing purpose-built EAM software is that it comes with standard, core features designed to streamline processes for regulated companies. I discuss this in more detail in our recorded webinar, Managing Compliance Risks with EAM.
Purpose-built GMP asset management systems, such as Blue Mountain RAM, come with out of the box functionality that provide immediate benefits. In terms of compliance and the FDA, it is vital that your EAM/CMMS was built from the ground up to support electronic signatures (21 CFR Part 11) (which will aid in going paperless down the road) and an audit trail of all changes made to an asset, work order, or another record stored in the EAM. These two functions are some of the most basic, core needs for GMP facilities.
You also need a system that is validatable. In this area, it is important to purchase from a vendor who has experience installing their software in regulated industries in which validation is a requirement. The vendor can support you in your validation effort by providing services to perform IQs, OQs & PQs and take into account any customizations that you may have made in the configuration process. It will benefit you far down the road to have a vendor you can rely on and also that can aid in re-validation efforts and minor configuration changes.
This is a quick overview of some basic necessities in EAM software for GMPs. In the next blog, I’ll break down maintenance, calibration and validation functionality in terms of managing compliance risks.
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