FDA CRF 21 Part 11
GMP Annex 11
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.
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
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 Synap IoT 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.
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 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.