RMS Systems Explainer Videos

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Rotronic Monitoring System - Overview and Architecture

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.

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Highlights of Rotronic Monitoring System

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.

Data Logging ICON

Digital Probes:

  • High accuracy
  • Long term stability
  • Hot Swap
  • Calibration/Adjustment data stored on probe
  • Automatic probe replacement recognised by the RMS software
Data Logging ICON

Fully Automated Data Logging:

  • LAN, wireless and WiFi communication
  • PoE, 24V and Battery powered
  • 44’000 or 12’000 data point memory
Compliance icon

Real Time Notifications:

  • E-Mail
  • SMS
  • Hot Swap
  • Telephone calls
Gear ICON

Automated & Customizable Reporting:

  • Data analysis reports, including batch release & certification
  • Deviation reports
  • Audit trail reports
  • Calibration reports
  • Validation reports
  • Characterization (mapping) reports (DIN12880, NF X 15-140, USP1079, WHO Supplement 8)
  • Service reports
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Compliance:

  • GAMP5 A Risk-Based Approach to Compliance GxP Computerized Systems (Second Edition). GAMP Good Practice Guide: Enabling Innovation
  • FDA 21 CFR Part 11
  • EU Annex 11: Computerised Systems
  • EU Annex 15: Qualification and Validation
  • FDA 21 CFR Part 210 and 211
  • ISO 14644-1 and ISO 14644-2
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Multiple Software Solutions:

  • Public SaaS
  • Exclusive SaaS
  • On-premis

What’s the difference between regular monitoring systems and our highly optimized Rotronic Monitoring System?

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.

Flexibility:

Data Import:

  • MODBUS TCP
  • JSON API
  • PDF, CSV and other documents

Data Export:

  • PDA A
  • CSV
  • JSON API
  • OPC UA
  • MS SQL

Multiple Parameters:

  • Temperature
  • Relative humidity
  • CO2
  • O2
  • Differential pressure
  • Particles
  • 0…1/5/10V
  • 0/4…20mA
  • Digital inputs

Lowest Total Cost of ownership:

  • Calibration/Adjustment and report via the software.
  • Mapping report via the software.

Selected Applications

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.

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Healthcare Room Monitoring

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Environment Monitoring and Contamination Control During Medical Device Production

Medical devices are one of the products regulated by the FDA...

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Pharmacies/Chemist's/Drugstores

Pharmacies/Chemist's/Drugstores

A pharmacy, chemist’s or drugstore is a physical location that, amongst others, distributes medication for patients. The distribution is subject to...

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Environmental monitoring for clinical and diagnostic laboratorie

Environmental Monitoring for Clinical and Diagnostic Laboratories

Strict environmental monitoring requirements are set by various professional bodies’ codes of practice and...

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Architecture of Rotronic Monitoring System

FAQs

  • GxP 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:

    • Contamination: Products may become contaminated with microbes, chemicals, or other environmental factors, potentially harming patients or consumers.
    • Product Recall: Contaminated or compromised products might need to be recalled, leading to significant financial losses and reputational damage.
    • Regulatory Actions: Non-compliance can result in warnings, fines, or even facility shutdowns by regulatory authorities like the FDA.
    • Patient Safety Risks: Inadequate environmental controls can compromise patient safety, leading to severe health consequences.

  • 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:

    • Implementing Robust Monitoring Systems: Regularly monitor environmental conditions, such as temperature, humidity, and particulate levels, in all GxP-regulated environments.
    • Compliance Audits: Regular audits and inspections to ensure compliance with GxP regulations.
    • Staff Training: Ensure that all staff are trained on the importance of environmental monitoring and how to maintain it.
    • Immediate Corrective Actions: Develop and enforce a protocol for immediate corrective actions if environmental monitoring detects a deviation from acceptable conditions.

    • Regulatory Sanctions: Continued non-compliance can lead to severe penalties, including facility shutdowns and revocation of licenses.
    • Loss of Trust: Repeated failures can erode trust with regulatory bodies, consumers, and patients.
    • Financial Losses: Recalls, legal fees, and loss of business can result in significant financial damage.

  • Regulatory bodies like the FDA, EMA, and WHO have stringent guidelines on environmental monitoring in GxP-regulated environments. These guidelines typically require:

    • Continuous Monitoring: For critical environments, continuous monitoring is expected to ensure that any deviations are immediately detected and corrected.
    • Documented Procedures: All monitoring activities must be documented and readily available for inspection.
    • Regular Calibration and Maintenance: Monitoring equipment must be regularly calibrated and maintained to ensure accuracy.

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