Synap IoT: 

 Automated Compliance 

Full Compliance

Do you want to save time and money and eliminate manual temperature recording of refrigerators and freezers while increasing your compliance?

We automate the logging process, create reports for the authorities - so that they are available to you digitally every day. Your documentation and all compliance documentation is stored completely and securely in the cloud, as well as for your next inspection visit always available and GxP compliant.

Intuitive GxP-environment 

Our infrastructure and products are specially developed for the regulatory requirements of an GxP environment: 

  • Intuitive and clear dashboard and user interface

  • Individual control and adjustment of all sensors and data loggers 

  • Guides intuitively guides you through the individual processes 

  • Graphical display of the measured values 

  • Individual configuration of measuring intervals, tolerance and limit value settings 

  • Intuitive export function (Excel, CSV and PDF)

GxP Conformity 

In the GxP-regulated environment, particularly strict requirements are placed on QM (quality management). Not only GMP (Good Manufacturing Practice) or GLP (Good Laboratory Practice) play a role, but also GDP (Good Distribution Practice) guidelines. Compliance with the regulatory guidelines for storage and transport of pharmaceutical drugs (products, excipients and intermediates) can be documented with SynapIoT without any problems. 

FDA 21 CFR Part 11

The regulation 21 CFR Part 11 of the FDA (U. S. Food and Drug Administration) is considered best practice, and Annex 11 of the EU GMP is also based on this regulation. This guideline mainly specifies requirements for digitally stored documents in which electronic stamps and signatures are made. 

Our infrastructure and products were developed with these requirements in mind. We have built-in and unavoidable restrictions on access authorizations and a timestamp documented audit trail and digital signatures. This ensures a 21 CFR Part 11 compliant environment and use of our data and temperature loggers. 

WHO/PQS/E06/TR05-VP.1 

Due to the demanding cold chain requirements for vaccines, among other things, UNICEF (Supply Division) and WHO have established guidelines for the quality characteristics of test procedures, calibration and measurement accuracy of the instruments. We have developed our products with these strict quality specifications.

 

ISO 9001:2008 

ISO 9001:2008 is the most important standard for QM systems in the international environment. It ensures that the basic conditions for adequate quality are given for both products and processes in the environment. However, it is essential to be well informed about the quality assurance of the suppliers involved. SynapIoT fully complies with these requirements and ensures compliance with the standard both through internal audits and accredited external inspections. 

 

SynLab IoT

SynLab IoT is the research and development center of SynapIoT. Here we work on synergies from the combination of the disciplines of engineering, software, mathematics to implement applied research and development. In cooperation with our project partners and our clients, we help to realize ground-breaking and innovative projects and thus create comparative advantages through digitization.

 

Here you can get inspiration from our IoT modular system. We offer you a variety of sensors, transmission technologies and hardware specifications. Please let us know your challenge, together we will find the best solution in the sea of ​​possibilities.

Azure SynCore IoT-Platform

SynCore ™ is the IoT-Platform from SynapIoT - here you can manage all your sensors. We even integrate third-party sensors into SynCore ™. So you have an overview of all relevant sensor data in a dashboard.

 

  • All sensor data in the dashboard

  • Export reports (PDF, CSV, Excel)

  • Set tolerance limits for alarms (min., Max. And tendencies)

  • Manage notification recipients (SMS and e-mail)

  • Predictive maintenance

  • Calibration value (setting)

  • Update hardware firmware (manual / automatic)

 

IoT Products

We offer predictive maintenance as well as automatic temperature recording, logging and monitoring for containers, air conditioning systems, trucks, refrigerators and freezers.

 

Do you want to save time and money and eliminate the manual temperature measurement of refrigerators and freezers while increasing your compliance?

We automate the logging, create the reports for the authorities - so that they are digitally available to you every day. Your documentation documents and all compliance documentation are stored completely and securely in the cloud,

and always available for your next test visit and set up in accordance with GxP.

 

Our patented predictive maintenance algorithm continuously monitors the parameters of the cooling unit. Deviations in the pattern are recognized immediately and can predict a possible future failure within 2-4 weeks.

 

Denmark 

info-dk@synapiot.com

Tel.: +45 5143 4967

 

Germany 

info-de@synapiot.com

Tel.: +49 (0) 89 5896 3989

 

United States

info-us@synapiot.com

Tel.: +1 (646) 361 0109

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