Comprehensive approach to the Facilities and Equipment subsystem of QSIT

Despite managing and working with assets differently, there are certain benefits from improving collaboration between calibration and maintenance personnel. First, there are the duplicated efforts involved in using two separate and distinct systems. For the most part, each group is working with the same set of assets, collecting a lot of the same profile information on the asset: description, ID, manufacturer, applications, etc. This brings up questions not only of efficiency but also compliance concerns when identical information, with possible variations due to errors, is being stored in multiple locations.

There were also some similarities between how the groups work with assets: maintenance, calibration and validation events occur for many assets on a set schedule, with a procedure or collection of procedures to follow for each event, and requirements for documented evidence that the event took place. However because maintenance personnel generally manage activity through work requests and have to manage inventory (with like-for-like replacement concerns in life science industries); and calibration personnel prefer to manage activity from an instrument-centric approach with standards traceability and measurement data collection, a single system that does not require a compromise to one group’s efficiency or compliance has been difficult.

No where has the drive for harmonization between calibration and maintenance management systems been more keenly felt than the life science industries. Within these industries, not only are there some real similarities for the management of these activities, but also ultimately the goal is also the same for everyone: to keep the process working as designed in order to preserve the controlled and validated state. In this effort, there is interaction that takes place. For example, during the initial commissioning of a new piece of equipment, it passes through a complete validation cycle that includes calibration. Once in production, routine maintenance is usually performed on it that in many cases will require recalibration before it can re-enter production. When routine maintenance isn’t enough to fix a problem or replacement parts are no longer available, the asset enters a change control process that will require revalidation and calibration once a solution has been worked out.

Blue Mountain Regulatory Asset Manager offers a platform designed to satisfy the needs of calibration, maintenance, and validation individually while enabling collaboration between all groups. Common information about assets is stored in one place, but each group can work with those assets in a way that makes sense for them. When events are scheduled or completed a notification can be sent to another department so if follow up activity is required it can be scheduled quickly and efficiently. When changes are required, a configurable approval routing path can secure the required approvals and keep everyone informed seamlessly.

Even such additional asset and facility management activity as IT asset management and environmental monitoring is easily supported by Blue Mountain Regulatory Asset Manager.

Additional benefits of this harmonized approach include:

• A single system to validate
• Lower computer hardware and system maintenance costs
• Clean and simple upgrade path
• Lower overall costs of ownership