Blur abstract background of ultra low temperature freezer for specimens storage in laborat

Automated regulatory logging with PharmaGuard

We are providing One Simple Solution to Pharmaceutical companies that completely automates report generation of regulatory data like temperature, humidity, and airpressure.

One Simple Solution is eliminating all obselete USB loggers by providing on cloud based solution for all monitoring in the company, making it easier and cheaper for the regulatory department to stay compliant.

FIND RESELLER

Challange

Do you want to save time and ensure the right temperature?

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

Do you want to plan maintenance and be warned for breakdowns in advance?

Solution

We offer automatic temperature logging of cryogenic and high-grade pharmaceutical freezers down to -200 degree celcius as well as intelligent predictive maintenance.

We create the audit reports for your customers, partners and autorities and enable the possibility of remote auditing during the current pandemic.

The automatically generated compliance documentation are stored in the cloud, and always available for your next audit visit and set up in accordance with GxP.

Features and functions

Audit Reports

Every night audit reports are automatically generated with all the collected telemetry, incidents and summary information about the device.

No more manual data collection is needed.

Internet connectivity

Synap IoT devices is not being connected to our customers internal network. All devices are automatically connecting to the Internet and deliver data directly to the Synap IoT cloud based platform. Even if our customer looses theri Internet connection the devices will still be operationel.

Global coverage

With One Simple Solution from Synap IoT we have coverage in 180 countries. This means that logging devices can be install in any country and reports and alerts can be monitored in the company HQ in another country

Alerts and warnings

Threshold values are set on each device individually and also which usres to notify if the threshold values are reached. We are operating with warning and alert values.

Role based users

Users in our portal are all devided into different roles like Admin, Maintenance, Content owner and report user.

Every role grants the specific user access to more or less functionality in the portal to ensure that the data and settings are keept safe.

FDA CFR 21 Part 11

Our Software solution is FDA CFR 21 Part 11 compliant and with our One Simple Solution our customers will receive the UAT and URS documentation for validation purpose included in the subscription.

UAT & URS Documentation

We update and add more functionality on a quaterly schedule and this will be communicated to our customers with a change description and new feature description and the UAT and URS documentation will be available in the Platform

Blockchain

In Q1 2022 we will implement our Blockchain solution so that all regulated data, incidents, solutions to incidents will be stored in Blockchain to ensure that the data is tamper proof and non-changeable.

Automatic Temperature documentation

FDA, CFR 21 Part 11 & GxP compliant

Notification of temperature deviations

Predictive maintenance algorithm

NB-IoT, 4G, 3G and GPRS transmission

Predictive Maintenance with Machine Learning

In the setup phase, we support you in setting the relevant parameters. By using machine learning our system gets to know your cooling unit better and better, so that irregularities can be detected earlier and earlier so that a service technician can address the problem to prevent your cooling unit from being damaged or even failing.

We are able to predict if the cooling system is about to fail, and make sure sure that the proper persons are notified in time. Tis help ensure that the content is keept safe and that it can be moved to another cooling location in time and under controlled procedures.