The use of Internet of Things (IoT) platforms and sensors has become increasingly popular in industries like pharmaceuticals and food and beverage manufacturing. One of the biggest challenges for these industries is complying with Good Manufacturing Practices (GMP) and regulations like 21 CFR Part 11, when it comes to bringing in new technology which has drastically slowed down their ability to keep up with change. Fortunately, Empiric’s IoT platform and sensors are designed with GMP/21 CFR Part 11 compliance in mind, making them a viable solution for facilities in these industries.
Learn more about how these real-time monitoring solutions can help improve efficiency, reduce costs, and ensure the highest product quality.
What Are GMP Regulations and 21 CFR Part 11?
Good Manufacturing Practices (GMP) regulations are guidelines that ensure that pharmaceutical and food & beverage products are consistently produced and controlled to meet quality standards. 21 CFR Part 11 is a regulation that applies to electronic records and signatures in the pharmaceutical industry. It mandates that electronic records be trustworthy, reliable, and accurate. Compliance with GMP and 21 CFR Part 11 is essential to ensure the safety and quality of pharmaceutical and food & beverage products.
How Empiric’s IoT Platform and Sensors Ensure Compliance
Empiric’s IoT platform and sensors are designed with GMP/21 CFR Part 11 compliance in mind. To ensure compliance, the platform provides secure data aggregation, from the device all the way to the cloud, audit trails, user authentication, and alerting and reporting capabilities. Data collected by Empiric’s sensors is securely stored and encrypted, ensuring that it cannot be tampered with or deleted. Audit trails track all user activity, providing an added layer of security. User authentication ensures that only authorized personnel can access the system. Real-time alerting and reporting capabilities enable quick detection of deviations from required parameters, ensuring that corrective action can be taken promptly.
How Empiric’s IoT Platform and Sensors Ensure Compliance
Compliance-focused features ensure that products meet the highest quality and safety standards. At the device and platform level, we have closed systems (with record detection, availability for inspection, record protection), Security Controls to limit access, Audit Trails, Automated Authority Checks, Device Data Encryption, Controls for Identification Codes/Passwords, and Electronic Records.
In addition to these compliance-focused features, Empiric’s IoT platform and sensors also offer several benefits for pharmaceutical and food and beverage facilities. These include:
- Improved Efficiency: By providing the ability to easily configure machine learning models and automated workflows, Empiric’s IoT platform and sensors can help facilities optimize their processes and predict downtime.
- Reduced Costs: By providing real-time monitoring and alerting capabilities, Empiric’s IoT platform and sensors can help facilities detect and correct issues before they become costly problems.
- Increased Product Quality: With out of the box LTE and secure data transfer, Empiric’s IoT platform and sensors can help operators continuously remotely monitor critical production processes, live, to ensure that their products meet the highest quality standards.
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Data Integrity: All data collected by Empiric’s sensors is securely stored and encrypted, ensuring that it cannot be tampered with or deleted. This is essential for meeting the requirements of 21 CFR Part 11, which mandates that electronic records be trustworthy, reliable, and accurate.
