Calibration, and the management thereof, is one of the cornerstones of a compliant facility or process. There must be reasonable assurance that a process is accurately measured. This assurance will provide regulatory authorities the confidence necessary to accept the data residing in batch records or assays. For a large facility calibration management can be a daunting task. A risk analysis can help narrow the list of critical instruments. but the task of calibration management has been the source of many FDA 483 observations through the years.
An accepted way to organize, track, and maintain the entire spectrum of equipment information is a database application such as a Calibration Management System (CMS). Such a system can be useful not just in operations but also in FDA inspections. A CMS will be required to fulfill the multi-dimensional role of tracking the diverse information represented in the instrumentation life cycle. Not only are the actual calibration data needed, but also the inventory with detailed information about each piece, and their associated histories. Another nuance is the use of electronic signatures and 21 CFR Part 11 compliance. The ability to approve calibration activities electronically and identify the responsible parties is no longer a luxury - it is a necessity. Creation and maintenance of such a system is required in today’s paperless information age.