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The organization that does not control its process controls, does not control its process! Controlling the process controls consists largely of calibration of those controls on a regular basis. Just as the Second Law of Thermodynamics tells us that equipment wears out and requires regular maintenance, so also does instrumentation as a specialized subset of equipment maintenance. In order to maintain the validated state, regular compensation for this "wearing out" must be applied via a Calibration Program. Thus 21CFR 211.68 contains some unusually specific requirements for calibration. Calibration must be performed according to written Procedures. Calibration Practices, must conform to those procedures and Paperwork must be maintained accurately to provide a history for the instrument being calibrated being serviced. These three requirements, Procedures, Practices, and Paperwork make up the Three-legged Compliance Stool common to all compliance activities. Without one of these legs, or a shortened leg, the stool becomes unstable.
Requirements for a Compliant Calibration Program should also include:
These elements must be incorporated into a robust Calibration Program to ensure compliance. PTS can help your organization develop a comprehensive program using our extensive experience to guide the effort in techniques that work and avoiding concepts that are not rigorous enough or lack the pragmatism to be sustainable. We can provide direction for a risk based process of classifying instruments and setting appropriate limits to ensure product quality and avoid unnecessary deviation investigations.
The Principal of PTS has been helping start-up and established companies as well as those under "regulatory distress" for many years, working with corporate and site personnel to develop standards and administrative procedures for calibration activities. Some clients were proactive in setting up the programs before problems arose or as preparation for regulatory review of new facilities. Many other sites have implemented our calibration and/or maintenance programs, after receiving a Warning Letter or entering into a Consent Decree with the FDA.
A very important part of a compliant calibration program is the tool used for scheduling, recording, and tracking calibration and repair activities. This functionality is often meager in a Computerized Maintenance Management Program and is better served by a Computerized Calibration Management System. To help guide your investigation into this necessary tool, we have provided below links to recommended, industry-leading, Computerized Calibration Management Systems (CCMS).
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