For life sciences companies, it is critical that all equipment is in good working order to produce safe, high-quality products—and calibration is a core component. To meet ISO 9000 quality standards, companies must manage equipment master records, equipment history records, calibration scheduling and recall, reporting, and standards and procedures traceability. Without proper calibration processes in place, your company risks lapses in accuracy, reliability, and quality when conducting important work. Many companies use different processes to meet these standards, ranging from pen-and-paper or spreadsheets to “smart” calibration devices and integrated software systems, or some combination of all of them. However, this task is too important and expensive to continue relying on outdated or disjointed processes. In fact, the global market for validation, calibration, and standardization in the global life sciences is estimated to exceed $2.1 billion by 2023 according to a report by BCC Research. Read on to understand the challenges of traditional calibration methods and learn how you can consolidate your calibration processes on one platform. Consolidating everything to one platform helps you ensure measurement accuracy and: Improve data integrity by maintaining traceability and documentation Ensure compliance Promote safety Reduce operational costs Extend the lifecycle of equipment The Challenges with Traditional Methods While calibration procedures vary based on the equipment, the process generally includes testing and documenting instruments based on known values or standards to ensure measurement accuracy before use. Initially, technicians would conduct the calibration, record it with pen and paper, and physically file it away until an audit. Companies that continue to use pen and paper in any capacity risk misplacing or damaging documents and miscalculating calibrations. Plus, the documentation is time-consuming and difficult to reference when making business decisions, and there is a risk of receiving an FDA warning letter if processes are not robust enough. As technology advanced, technicians began recording calibrations in digitized databases and spreadsheets, which helped prevent the loss of information. However, this method is also time-consuming and error-prone, especially given that technicians often still record the calibrations on paper and then transfer them to the spreadsheet. This adds another step where data can be entered incorrectly and is a duplicate effort. Spreadsheets and databases are also static documents and do not automatically record changes, which can affect quality audits. Integrate Calibration with Nuvolo Connected Workplace for Life Sciences In recent years, many companies have developed dedicated calibration software and modules, where technicians can manage and record calibration data, set reminders for future work, analyze trends, and integrate with other systems. Nuvolo took it a step further and created the Connected Workplace for Life Sciences, which connects all people, places, and processes across your organization, including facilities and maintenance for regulated and non-regulated environments. The Maintenance solution includes Calibration, which provides you with a modern and streamlined calibration solution. It also: Enables administrators to specify calibration parameters, tolerance levels, reference standards, or test weight sets for each asset Allows technicians conduct calibrations tests, which are selected as individual data sheet templates Allows technicians to record – per test point – input and output calibration values, reference standards used, and comments Automatically calculates errors and indicates PASS/ADJUST/FAIL for each test point in real-time and stores results with a date/time stamp Ensures only serviceable reference standards are used to perform calibrations; reverse traceability is there if something goes wrong Supports common error calculations and math functions with out-of-the-box formulas Stores detailed calibration history for each asset Schedules real-time work orders if a problem is identified during a calibration inspection With all calibration information stored in one place, your team will always be audit ready. Interested in learning more about our calibration capabilities? Check out the solution overview. We are also working on improving the calibration solution even more. Stay tuned for upcoming updates. Share
