Want more information on how data monitoring and RMS works?
Check out on of our explainer videos to see how our systems can improve your processes.
The Rotronic Monitoring System is a modular system of hardware elements and web-based software. It provides maximum flexibility in installation and ensures readily available data. The data loggers record measurements from Rotronic and third-party sensors and transmit them to the secure database. It stores information and makes it available to users, regardless of whether they access the database via a PC, Mac, tablet or smartphone.
Contact us for more information.
Our temperature sensors and probes offer real-time data, audit tracking, and automated regulatory compliance. Ideal for hospitals, pharmacies, laboratories, food safety, or transit applications, our systems ensure perfect monitoring for your needs. Monitor environmental conditions enterprise-wide in real time.
Rotronic Monitoring System – Ensuring Precision and Compliance
The Rotronic Monitoring System offers unparalleled precision, flexibility, and reliability for environmental monitoring. Designed by the pharmaceutical industry for the pharmaceutical industry, the Rotronic Monitoring System is a GAMP©5 category 1 software combined with category 1 hardware, helping users monitor their GxP compliant applications, looking into the critical quality attributes and monitoring critical process parameters, helping focus on patient safety, product quality and data integrity and compliant to EudraLex Annex 11 and FDA 21 CFR Part 11. Its modular architecture allows seamless integration into existing systems, while real-time data access and customizable alarms provide immediate insight into critical conditions. With cloud-based or on-premis access and robust data security, RMS guarantees uninterrupted performance, delivering peace of mind for industries where data integrity is crucial.
Data Import:
Data Export:
The Rotronic Monitoring System is one of the most flexible monitoring systems available on the market today. From small applications with one measurement point to larger systems with several thousand measurement points, RMS offers tailor-made solutions. Existing hardware can be integrated into the Rotronic system and, vice versa, Rotronic hardware can be incorporated into existing software. According to your wishes and requirements for a continuous monitoring system.
The Rotronic Monitoring System can help with 3 critical applications that require environmental monitoring within the healthcare...
Read MoreMedical devices are one of the products regulated by the FDA...
Read MoreA pharmacy, chemist’s or drugstore is a physical location that, amongst others, distributes medication for patients. The distribution is subject to...
Read MoreStrict environmental monitoring requirements are set by various professional bodies’ codes of practice and...
Read MoreGxP stands for "Good Practice" guidelines and regulations that apply to various fields such as manufacturing (GMP), laboratory (GLP), and clinical (GCP) settings. Environmental monitoring is crucial in these environments to ensure product safety, integrity, and efficacy. It helps prevent contamination, ensure consistent quality, and maintain compliance with regulatory standards.
Failure to implement environmental monitoring can lead to:
COVID-19 Vaccine Storage Issues (2020-2021) Case: During the global rollout of COVID-19 vaccines, temperature control became a critical issue, particularly for mRNA vaccines like Pfizer-BioNTech and Moderna, which required ultra-cold storage conditions. Several incidents were reported where improper storage temperatures led to vaccine doses being deemed unusable. In one instance, in Wisconsin, hundreds of doses of the Moderna vaccine had to be discarded after they were “stored” at too high a temperature. Impact: Loss of valuable vaccine doses during a critical period, delays in vaccine distribution, and increased costs. Link Insulin Storage and Transportation Failures (Multiple Incidents) Case: Insulin, a temperature-sensitive drug, has been involved in several incidents where improper storage or transportation conditions led to degradation. For example, a study found that up to 93% of insulin deliveries experienced temperature excursions, with some instances leading to compromised efficacy. Impact: Compromised efficacy of insulin, potential harm to patients relying on the drug, product recalls, and significant financial losses. Link Humidity Control Failures in Pharmaceutical Production (2018) Case: A major pharmaceutical manufacturer faced significant challenges due to humidity control issues in their production facility. In 2018, the FDA issued a warning to a pharmaceutical company after it was found that high humidity levels in their manufacturing area led to the degradation of an active pharmaceutical ingredient (API) in one of their drugs. This issue resulted in the contamination of batches and a subsequent product recall. Impact: Product recalls, financial losses, regulatory scrutiny, and potential risks to patient safety due to compromised drug quality. Link These cases highlight the critical importance of maintaining proper temperature and humidity controls in environments where sensitive pharmaceutical products are handled, stored, or manufactured.
Companies can prevent these issues by:
Regulatory bodies like the FDA, EMA, and WHO have stringent guidelines on environmental monitoring in GxP-regulated environments. These guidelines typically require:
Contact our experienced engineers to discuss your application needs.