Meet FDA Temperature Monitoring Requirements with AiroSensor
Revolutionizing Food Waste through Temperature Monitoring
The U.S. Food and Drug Administration (FDA) offers a globally recognised framework for ensuring the safety, efficacy, and quality of pharmaceuticals, medical devices, food products, and other regulated goods.
To guarantee regulatory compliance and product safety, the pharmaceutical, life science, and food and beverage industries require the support of sophisticated data monitoring tools.
Opting for advanced FDA-compliant data loggers with complementary technologies, however, is what drastically simplifies the regulatory compliance process. We explore these leading technologies alongside SenseAnywhere’s FDA-compliant data logger, the AiroSensor.
What are the FDA guidelines for temperature monitoring?
The FDA oversees the manufacturing and distribution of a wide range of food and pharmaceutical products, including drug testing protocols, storage processes, and food production practices to ensure public safety and health.
Drawn from GMP and GDP standards, FDA guidelines emphasize the essential role of manufacturers, distributors, and stakeholders to control and monitor the environmental testing and storage conditions of their associated products.
Strict parameter control, specifically including temperature and humidity, is essential for maintaining product quality, safety, and integrity. This makes data monitoring systems fundamental within FDA protocols, delivering reliable product preservation throughout the production, storage, and distribution process.
Naturally, sufficient monitoring must involve compliant data recording and documentation. Heavily regulated sectors must show demonstratable adherence to dependable data recordkeeping, which relates specifically to section 21 CFR Part 11 of the compliance framework.
21 CFR Part 11 explained
Establishing a regulatory benchmark for essential data management, adherence to 21 CFR Part 11 guarantees the integrity of a stakeholder's electronic records and signatures.
Compliance with 21CFR Part 11 extends beyond data security, serving as a crucial assurance indicator of accurate, secure, and authentic digital data. Data records include temperature readings, timestamps, alarm events, and other pertinent information recorded by your data logger.
Given its importance within product management, FDA-compliant data loggers look to integrate specific technologies to enhance adherence to regulatory standards. Inspecting SenseAnywhere’s front-running, data monitoring system, the AiroSensor, we’ve detailed the essential features and key requirements of an FDA-compliant data logger below:
High-accuracy Sensors
Unsurprisingly, accurate electronic data records are a primary requirement for data monitoring systems. This is a feature that you would expect all data tools to reliably offer. Precise data records, however, particularly for parameter monitoring within crucial sectors, require a robust data capture process.
This is most easily achieved through automated, real-time data monitoring technology, which is where the AiroSensor shines. Its automated system provides a seamless solution to accurate and continuous data capture; the system offers a market-leading, high-temperature accuracy of down to ±0.1°C, +2% RH, and a long-term temperature stability drift of <0.01°C/year!
This is what places SenseAnywhere as one of the strongest candidates for meeting the stringent data accuracy demands of the pharmaceutical, food and beverage and wider life science markets.
Wireless connectivity
Wireless connectivity allows data loggers to seamlessly transmit temperature and other critical data in real-time. Paired with product protection elements such as configurable alarm settings, this enables stakeholders to monitor conditions remotely and respond promptly to any deviations, enhancing product safety and quality.
Wireless connectivity can further enable authorized personnel to access data logger readings and settings remotely, allowing for quick adjustment, troubleshooting and sufficient general management.
This is what can elevate a standard data logger to a vital safeguarding tool. The AiroSensor alarm features offer a fully protected monitoring solution with instant SMS, e-mail, or voice alerts. Alongside its real-time, continuous monitoring technology, this provides a fool-proof monitoring system that swiftly responds to potential integrity-damaging environmental conditions.
Reliable data encryption, integrity and security
For your electronic data records to be compliant, they must be protected against tampering or unauthorised access. This means that your monitoring system should incorporate additional protective measures, such as authentication and strict user control, to ensure reliable data reporting.
To further guarantee the safety of your records, monitoring systems should provide time-stamped audit trials. These will monitor any alterations, ensure transparency, and highlight that your records are truly original. Standard management processes must also incorporate consistent backup measures within their regular routine, which will help to protect against the threat of accidental data loss.
Utilising a cloud database offers a seamless solution to securely stored data. Take the AiroSensor’s cloud-based software as an example, which requires zero human interaction in the data collection process. This not only allows for a ‘back-up’ free solution, but with automatic data recording and reporting, it ensures that your data is genuine, authentic and reliable.
Offering a storage capacity for up to 15 years, the AiroSensor software is specifically validated to meet the regulatory requirements of FDA 21 CFR part 11. The SenseAnywhere software does not permit data modifications; a technology that highly compliments FDA requirements! With the AiroSensor, you can access your data anywhere at any time from the cloud and is stored securely for a minimum of five years.
Calibration and validation
What use is top technology without adequate maintenance and support? Companies must adhere to regular maintenance protocols to ensure regulatory compliance, with documented calibration and validation critical aspects of ensuring data accuracy and reliability.
This is something that SenseAnywhere recognize all too well. Did you know that the AiroSensor comes fully validated before its arrival? Better yet, the solution includes a swap-out feature for use during regular calibration servicing to ensure that your products are always protected, even during calibration periods.
AiroSensor: SenseAnywhere’s solution to FDA Compliance
Amidst the sea of data loggers available on the market, selecting a monitoring system equipped with built-in technologies specifically for FDA compliance is the best way to protect your pharmaceuticals, stored foods, and other strictly regulated products.
Withnell Sensors is renowned for its ability to support businesses with their specialist temperature and humidity technologies. As proud distributors of market-leading tools tailored for highly regulated sectors, we’re delighted to offer the AiroSensor as our flagship FDA-compliant monitoring system.
We further offer exceptional accredited calibration services for your AiroSensor across the UK and Canada regions, serving as your after-sales support partner throughout your data logger lifecycle.
Enquire for your 7-day free trial with Withnell Sensors to experience FDA-compliant product protection today.
