Obtaining accurate measurements is critical in making decisions and performing tasks within the life sciences industry. Calibration, the process of verifying the readings of an instrument match that of an independent standard, does precisely that. When an instrument is not within the required calibration tolerance, an adjustment is made to bring it back to within tolerance. Ideally, instruments are selected such that there is enough buffer allowing for the process itself to not be impacted (process tolerance) due to inherent instrument drift.
Azzur’s philosophy to Calibration is built upon a risk-based, data-driven approach that is aligned with latest guidance and best practices. The level of rigor in which Calibration best practices apply is commensurate with the risk to product quality and patient safety.
“Effective calibration is essential in achieving a high degree of confidence that a manufacturing process remains within the defined operating limits (ISPE GPG: A Risk-Based Approach to Calibration Management).”
Our approach considers all aspects of the equipment lifecycle: from acquisition and enrollment, to proper use and maintenance (i.e., periodic calibration), as well as decommissioning and retirement.
Instrument selection plays an important role in understanding and controlling a manufacturing, metrology, or equivalent process. Knowledge of the anticipated operating/acceptable ranges, critical process parameters, and/or target/setpoint(s)—including any relevant critical quality attributes—is imperative to ensure the appropriate instrumentation is used to control process parameters and equipment. The same applies when trying to select an instrument which allows for effective calibration to occur. Conformance to a ≥ 4:1 Test Accuracy Ratio (TAR) and ensuring OEM specifications are well understood ensures the appropriate standards are selected when performing calibration. We facilitate the instrument selection process by ensuring the right instrument is chosen the first time, with an appropriate accuracy that allows for potential instrument drift to occur such that impact to a process is limited, controlled and OOTs reduced.
- We have deep experience with implementing calibration programs for our clinical and commercial clients.
- Development and Implementation of an effective Calibration SOP and/or Policy
- Detailed procedures, aids/guides for calibrating equipment, onsite training
- Data Entry within Computerized Maintenance Management System (CMMS) or Calibration Management Software (CMS), including Qualification.
Azzur Group is pleased to offer NIST Traceable Instrument Calibration. Our calibration expertise includes but is not limited to the following: