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 However, this task is too important and expensive to continue relying on outdated or disjointed processes.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 life sciences is estimated to exceed $2.1 billion by 2023 according to a report by BCC Research.
The following article illustrates the challenges of traditional calibration methods and outlines the benefits of consolidating your calibration processes on one cloud-based platform.
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 miscalculating calibrations and misplacing or damaging documents. 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 their spreadsheets or point solution. This adds another step where there is duplicate effort and data can be entered incorrectly. Spreadsheets and databases are also static documents and do not automatically record changes, which can affect quality audits.
Conduct Calibrations with a Cloud-Based Solution
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. Other companies, like Nuvolo, have taken it a step further and have created cloud-based platforms that can connect all workplace facilities, maintenance, and calibration work in one place. This helps technicians and management in the following ways.
Companies who continue to use on-premise software are required to allocate budget for system maintenance. These upgrades are necessary to keep the system up-to-date and protected against security threats and other glitches. With a cloud-based solution, the overall cost of the system is usually lower, and any upgrade is implemented seamlessly and cost-effectively.
Companies who opt for point solutions pay individual companies for their systems, which can add up significantly. By consolidating these solutions on one platform—like Nuvolo Connected Workplace—your company can streamline operations while saving money.
Minimizes Errors and Protects Information
A mobile, cloud-based solution can also help reduce errors and keep information secure, all while improving efficiency. Because it is app-based, technicians have flexibility and mobility when doing their work. They can calibrate any piece of equipment, wherever it’s located, and enter relevant data directly into the asset record. With a solution like Connected Workplace, error and PASS/ADJUST/FAIL status calculate in real-time, further reducing potential errors.
Additionally, because gathering information and saving it is digitized and controlled, there is less risk of misplacing pen-and-paper measurements or losing information saved to a spreadsheet.
Establishes Compliance Through Traceability
Companies must meet quality and regulatory standards and should always be audit-ready. When you can easily track and identify each step in the process and every component used, you can more easily address issues and prove compliance with industry standards. Centralizing information and having built-in compliance workflows that meet CFR 21 Annex 11 requirements help keep all operations compliant.
While point solutions and traditional on-premises software can facilitate some of these features, conducting work using a cloud-based solution that connects other areas of your business has enormous benefits. In addition to the benefits above, cloud-based solutions can help companies achieve increased security, flexibility, mobility, insight, collaboration, quality control, disaster recovery, loss prevention, and a competitive edge.
Interested in seeing how you can modernize your workplace operations? Contact Nuvolo to learn more.