Now that I laid the framework for purpose-built EAM software and some core functionality requirements for regulated companies, I want to go into more detail about using EAM/CMMS features to manage compliance risks.
There are two important factors to note surrounding EAM/CMMSs in GMP environments:
- Maintenance and calibration work should be streamlined and simplified for technicians.
- Compliance requirements can be costly and time consuming – during initial configuration of a software and on-going usage.
This is where a purpose-built solution, like Blue Mountain RAM, will provide significant ROI for an organization because it is packaged with functionality that drives productivity, while providing necessary tools to manage compliance including customizable workflows with e-signature capability.
Here are a few examples of functions/concepts that can be used to manage compliance risks with EAM/CMMS software. These examples are based on our EAM/CMMS, Blue Mountain RAM:
- Paperless / Mobile – Compliance risks are greatly reduced by going paperless and utilizing mobile devices. This is because data entry is streamlined, technicians are no longer hand writing details on work orders and then typing them into the system at a later time. Safety checks are in place to catch mistyped data and alert the technician of potential mistakes. The technician can provide an immediate e-signature verifying that the work order is completed and transition it to a review state to be approved. Paperless and mobile devices reduce errors, prevent lost work orders, and ensure that everything is completed and approved in a timely manner. All events on a work order or asset are captured in an audit trail.
- Reporting – Reporting is also a key component in the management of compliance risks. We discussed this in a previous blog along with some detailed examples. Check out the previous blog.
- Non-Conformance Workflows – In the event that a calibration fails, the EAM/CMMS should immediately trigger a non-conformance report (NCR) and alert the proper department to follow up with the NCR. Because Blue Mountain RAM can be validated and configured with paperless workflows, there is no chance that NCRs will be lost. Management can clearly and easily review NCRs making sure they are completed.
- Change Control – With a flexible workflow engine, Blue Mountain RAM provides the ability to manage change controls starting from a change request and transitioning to all of the appropriate states. Blue Mountain RAM will track sign-offs and store details of the change request.
- Like-for-Like Parts – This pairs with change control. Blue Mountain RAM will track and manage Like-for-Like spare parts so that technicians are not undergoing a change request each time they are required to replace a ‘low-risk’ part. It is vital that your EAM/CMMS system comes packaged with this ability.
- Global Solution & Integration – Another key component in managing compliance risks with an EAM is the standardization of maintenance and calibration across an organization. The FDA wants to see consistency across all facilities. By utilizing a purpose-built EAM/CMMS application globally, you will not only satisfy the FDA, but you will also drive quality products. Siloed facilities are eliminated – which increases sharing, learning and process consistency across facilities / managers. In addition to using a multisite EAM/CMMS, it is also vital to integrate with other applications, such as MES, LIMS, ERPs, etc., to improve compliance.
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