Most calibration departments rely on a computerized calibration management system (CCMS) to manage and document calibration
activity. These systems are designed to meet the needs of a calibration department, including an instrument-centric approach
and features such as measurement data templates and reverse standards traceability.
Just as regulations require that regular calibrations be performed on equipment, regular preventive maintenance also must
be performed. This maintenance not only satisfies regulatory requirements for maintaining equipment in its original working
order, but also reduces the likelihood that more costly and disruptive emergency maintenance will be required. The challenge
is to determine the optimal frequency for preventive maintenance, just as the calibration professional must strive to establish
the optimal frequency and tolerances for calibration readings.
Any changes to the asset (i.e., when a similar replacement part is no longer available and new alternatives must be considered),
will require change control and completion of review and approval procedures before the asset can return to use. Speedy resolution
of change control and like-for-like replacement issues can make a huge difference on the bottom line when dealing with a multimillion
dollar piece of equipment or process line. In addition, when operating a maintenance group, managing a pool of people and
ensuring that the right person is available for each job is a constant challenge.
To manage all the complications of asset maintenance, many companies use computerized maintenance management systems (CMMS).
Activity in CMMS tends to be organized around work orders. If a CMMS was designed for use by biopharmaceutical manufacturers,
it can offer a way to manage replacement parts approved for each asset in the validated state.
A Systems-Based Approach
The Food and Drug Administration and other similar regulatory agencies have started to take a top-down, system-based approach
to inspections and audits, called the quality systems inspection technique (QSIT). Instead of looking solely at the end results
of processes or focusing on detecting small variations, QSIT focuses on the major elements of the total quality system that
are most critical to meeting requirements. As part of implementing this new technique, regulatory agencies are training their
inspectors in new areas of focus, including, for example, various disciplines in asset management.
The FDA has grouped Facility and Equipment controls into one of five manufacturing subsystems that make up a complete quality
system. According to FDA, the Facilities and Equipment category "includes the measures and activities which provide an appropriate
physical environment and resources used in the production of the drugs and drug products."3 See the sidebar for a list of the elements that FDA has grouped under the terms "Facilities" and "Equipment," which include
such additional activity as environmental monitoring and IT asset management.
Quality Systems: Facilities and Equipment
Biotech companies are realizing commonalities and interaction between the discipline and management of calibration, maintenance,
and validation. 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. There are also similarities in how various 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, with requirements for documented evidence that the event took place.
These commonalities raise questions not only of efficiency, but also compliance concerns when identical data, with possible
variations due to errors, are stored in multiple locations.
Taking a uniform approach to these activities and responsibilities is the first step toward achieving a complete and integrated
facility and equipment system, on which regulatory audits will pivot.