Real-Time Monitoring Solutions – Flexible and Configurable Environmental Monitoring.

The PST real-time monitoring solutions (RMS) are designed to help customers ensure compliance within regulated applications. Monitoring anything from temperature, relative humidity and other environmental parameters that PST can offer. The PST RMS offers a range of installation possibilities with both public and exclusive SaaS solutions, On-Premise or directly with a server provided and monitored by PST. Our systems ensure data integrity and help comply to FDA 21 CFR Part 11 and EU Annex 11 requirements.

Isensix Monitoring Solutions

GxP V Model

We provide wireless, real-time monitoring of environmental data. Guardian is a secure, customizable solution for multiple applications across a wide variety of facilities including hospitals, laboratories, blood and tissue banks, biotech and more.

What makes Guardian so special?

  • We mitigate risk
  • We are a cost-effective solution
  • We offer seamless integration
  • We provide unsurpassed accuracy
  • We maintain superior, 24/7 protection

Guardian on the Isensix Website

Isensix Guardian Technology

The Guardian hardware provides a single point of control for less-risk, features a fail-safe power source and is highly customizable:

  • Only monitoring system with a key pad to address issues on the spot, allowing you to document by touch, at the source
  • ‘Shore powered’ with battery backup for most critical applications. Battery-powered for certain types optimized to maximize power
  • System can be configured to work in any facility with minimal disruption during set-up

Isensix Guardian technology provides unsurpassed benefits:

  • FCC-approved wireless, cost-effective sensors
  • 100% digital, easy-to-use, web interface, with simultaneous multi-user-level access
  • Central collection on a secured server with Intranet-wide remote access
  • Real-time visual, audio, e-mail, paging and voice alerts notifications
  • Easy to access record keeping
  • Assists in meeting Joint Commission (JCAHO), CAP, FDA, AABB, and GMP requirements
  • Acts in accordance with the FDA 21CFR Section 11 electronic signature requirement
  • Automated compliance reporting, corrective action logs, and back-up
Guardian Facilities and Benefits on the Isensix Website

Rotronic Monitoring System

GxP V Model

The Rotronic Monitoring System (RMS) is a GAMP©5 category 4 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 EU Annex 11 and FDA CFR 21 Part 11. Rotronic AG design and manufacture RMS hardware and software based upon the GAMP©5 guidelines.

System Overview

The Rotronic continuous Monitoring System allows user to monitor anything from anywhere using an On-Premise or SaaS - Public Cloud software solution. Rotronic offer an SaaS - Exclusive Cloud option for any regulated customer that needs a validated SaaS software solution.

Assured data integrity:

  • All RMS measurement devices have an internal memory
  • Wired dataloggers with PoE, 24V and backup battery power
  • Wireless dataloggers with 24V and/or backup battery power
  • Encrypted LAN communication
  • SaaS solutions hosted within an ISO27001 certified datacenter
  • Secure data access via HTTPS connection and read/write rights only (no delete rights)

Integration of 3rd party devices:

  • Integration via analog input
  • Integration via MODBUS TCP protocol
  • Integration via API

Data Export possibilities:

  • Export data in .csv or .pdf format
  • Export data via API
  • Export data via OPC UA

Turnkey Solution Provider:

The services offered by PST Rotronic are setup following the GAMP©5 life cycle approach to improve GxP compliance efficiency.

  • Project Management
  • System Qualification, including thermal mapping
  • System Validation, including all necessary validation documents
  • Calibration services (ISO17025 and traceable)
  • Support and SLA’s
Rotronic Monitoring System: Environmental Monitoring for GxP Regulated Applications.