It’s important that regulatory compliance standards are upheld in the pharmaceutical industry and food supply-chain to ensure the quality and efficacy of products. To maintain the integrity of these items, it’s crucial to monitor environmental conditions, such as temperature and humidity, during manufacturing, storage and logistics with a calibrated data logger.
Keep reading this blog to learn how data logger calibration is imperative for reliable data collection, and the precise validation processes they must undergo to be approved by regulatory authorities.
Why Data Logger Calibration Matters
Data logger calibration verifies that a data logger performs as it’s supposed to, specifically within certain parameters. This calibration process involves a series of tests and documentation to confirm that the device meets regulatory requirements and industry standards before being used on products.
Regulatory bodies like The Food Standards Authority (FSA), the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) have strict requirements that pharmaceutical or food manufacturers must complete data logger calibration to ensure that they comply with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
Companies that don’t adhere to GMP or GDP from these regulatory bodies run the risk of facing penalties, fines and product recalls, making data logger calibration a key step in their processes. It’s important that these businesses obtain a calibration certification that proves their calibrated temperature and humidity data loggers have been calibrated to the required standards.
At Loggershop, we provide data logger calibration services, where the device is tested and verified against a United Kingdom Accreditation Service (UKAS) calibrated reference device. We also offer re-calibration services, with proof of a previous certificate reference..
The Role of Data Loggers
Calibrated temperature data loggers and other types, including humidity, light, pressure and shock/vibration data loggers, use sensors to measure and collect information. They have internal memory for storing the collected data about the environment that a product is stored or transported in. Once a calibrated temperature or humidity data logger has been set up, it will automatically record information. Some display data on the screen while others transmit wirelessly meaning the data can be accessed remotely.
So that these data loggers are providing crucially accurate readings, they must be regularly calibrated or re-calibrated so that they remain adherent to industry standards.
What Does Data Logger Calibration Involve?
There are 5 main steps in data logger calibration:
- Installation Qualification: The first step verifies that the data logger has been installed correctly, and that the installer has followed the manufacturer’s instructions.
- Operational Qualification: During the second step, the data logger is tested to make sure that it operates as it should under various different conditions. The tester will check the accuracy, response time and stability of the data logger.
- Performance Qualification: The third step involves testing the data logger in real-world conditions to ensure that it performs consistently and accurately over a period of time.
- Calibration: In the fourth step, the data logger’s readings will be compared with a specified standard and any necessary adjustments will be made – regular data logger calibration is essential to remain accurate.
- Documentation: The data logger calibration process must be documented in order to adhere to regulatory requirements, including test procedures, results and if any adjustments were made.
Data logger calibration services at Loggershop involve testing the data logger against a UKAS calibrated reference devices, and we provide both traceable and UKAS ISO17025 calibration work. We provide both Madgetech calibration and Logtag calibration.
Why Accuracy is Key: The Importance of Data Logger Calibration in Quality Assurance
Impact of Inaccurate Data
There are many potential risks of using uncalibrated or poorly calibrated data loggers, like poor and compromised product quality, failed audits and inspections and non-compliance fines and penalties.
Data logger calibration helps identify potential problems with a device before they can affect product quality or cause compliance implications, reducing the risk of product recalls and ensuring consumer safety.
Reliable Data Collection
Inaccurate data loggers that haven’t been calibrated or re-calibrated can damage the integrity of the data being collected, meaning they won’t be providing accurate readings of the environment and product quality can be diminished.
Calibrated temperature and humidity data loggers ensure reliable data collection, guaranteeing the quality and safety of products in the supply chain, like vaccines, medicines and perishable food items that require very specific conditions for storage and transportation.
Traceability and Compliance
If there isn’t any traceable proof of data logger calibration this can cause implications with compliance, as there is no way of proving that the device meets regulatory standards.
It’s important to be able to provide certifications of data logger calibration so that regulatory bodies like the FSA, FDA and EMA can see proof of GMP and GDP during audits and inspections.
Loggershop’s Data Logger Calibration Services
At Loggershop, our experienced technicians provide quick and accurate data logger calibration services to comply with regulatory standards. We provide both Madgetech calibration and Logtag calibration.
Data logger calibration services at Loggershop involve testing the data logger against a UKAS calibrated reference devices, and we provide both traceable and UKAS ISO17025 calibration work – this service is performed by our parent company, Wessex Power Technology.
There are also re-calibration services available, as long as a previous certificate reference is provided.
Ensure your products meet regulatory standards and maintain quality control – submit a data logger calibration enquiry today to get a quote from one of our expert technicians at Loggershop. To find a new data logger, take a look at our online store.
