InTemp VFC Compliant Temperature Storage Monitoring

Pharmaceutical temperature monitoring is primarily based on your organization's industry. The majority of InTemp customers are required to follow global GDP/GMP (GXP) compliance standards as well as country/region specific regulatory compliance monitoring guidelines outlined by organizations such as the FDA and EU. All InTemp products, with the exception of the CX402-VFC logger, meet all regulatory requirements in addition to a 21 CFR Part 11 / EU Annex 11, GDPR, and GAMP5 compliant cloud temperature data storage and monitoring solution. These products can be used for all Cold Chain monitoring needs within the Life Science (Pharmaceutical, medical device, biologics, 3PLs, etc.) and non-VFC Healthcare (Hospital, clinic, pharmacy, ambulatory, etc.) industries. The CX402-VFC logger was specifically designed for vaccine storage monitoring with the United States CDC. Any customer associated with the Vaccines for Children program should only consider CDC-compliant data loggers such as the CX402-VFC.

The CX402-VFC is a CDC-compliant data logger designed for vaccine temperature monitoring. It is specifically designed for the Vaccines for Children program in the United states for full compliance with CDC guidelines. It has audible and visual alarms, a probe in glycol bottle, high levels of temperature accuracy, and a 3-year NIST calibration certificate.

Yes!!! Both the InTempConnect cloud platform and mobile apps are completely free to use without any limitations. InTemp does not enforce limits on number of users, data logging intervals, amount of time data is stored**, etc. Simply go to https://www.intempconnect.com and click "create account" to get started. The only subscription fee is associated with the optional CX5001 (Wi-Fi/Ethernet) or CX5500 (Cellular) Gateway. The CX5001 Gateway is $50/year/Gateway and the CX5500 is $200/year/Gateway (for cellular data fees). While optional, the Gateways provide a tremendous amount of value by automating Cold Chain management and enabling remote temperature monitoring. All options provide an unbeatable total cost of ownership for pharmaceutical temperature monitoring.

**Note: Data is stored for up to 15 years in the InTempConnect cloud platform however, there are no fees associated with data storage.

Yes, the InTemp Cold Chain temperature monitoring solution is fully compliant with both US and global standards. The overall solution meets the following standards:

• ISO 9001
• ISO 17025
• 21 CFR Part 11 FDA compliant
• EU Annex 11 compliant
• GDPR
• GAMP5

Additionally all of our loggers have obtained certifications for:

1. RTCA DO160G, part 21H
2. CE
3. FCC
4. New Zealand & Australia (Not all loggers)
5. Japan (Not all loggers)

Most loggers have also been certified for use on most major and regional airlines (please contact InTemp sales for a complete list of airlines). Additionally, the InTemp is a highly secure solution with end-to-end encryption, configurable security settings including MFA, and a privilege based user role system to clearly define which users can perform different actions within the system.

Bluetooth temperature loggers provide an immense amount of value over traditional USB temperature data loggers. Enabling IoT temperature monitoring capabilities, wireless data logger solutions can:

• Send real-time temperature alerts via text message and or email
• Automate regulatory compliance reporting
• Allow for remote temperature monitoring
• Enable the use of mobile apps connected to cloud temperature data storage and monitoring solutions for unparalleled ease-of-use
• Allow you to personally customize your loggers settings such as alarm thresholds, logging rate, etc.
• And much more!!!

IoT temperature monitoring solutions for temperature-sensitive products can help to fully automate your regulatory compliance activities versus traditional USB temperature data loggers which typically require a lot of manual labor, cannot be customized, are less secure (greater risk for malware), and do not enable automation and remote temperature monitoring capabilities. Note: Several of the above mentioned features require the use of a CX5001 (Wi-Fi/Ethernet) or CX5500 (Cellular) Gateway.

The CX402-VFC is a Bluetooth temperature logger that can communicate with the InTemp mobile temperature monitoring apps and or CX5000 family of Gateways for a robust IoT temperature monitoring solution. If a logger is in an alarm state, the Gateway will automatically download the logger at the time of alarm, and trigger a real-time temperature alert notification. Users can receive these temperature excursion alerts via text message and or email. Additionally, email alerts can include PDF and or Excel based reports. The InTemp mobile app can also trigger a temperature alert notification however, you must be within Bluetooth range (100ft./30.5m) of the data logger to download it with the mobile app.

Yes, you are able to perform remote temperature monitoring activities with the InTemp cold chain monitoring solution. With the optional CX5001 (Wi-Fi/Ethernet) or CX5500 (Cellular) Gateway, you can remotely configure, start, and download you loggers from anywhere in the world. Additionally, Gateways will enable automatic, real-time critical excursion notifications that can be sent to you via text and or email. Note: The Gateway must be within 100ft (30.5m) of the Bluetooth temperature loggers (line of sight) in order to perform remote temperature monitoring activities and to receive automated temperature alerts.

Yes, the InTemp Cold Chain monitoring solution can be installed in one or multiple sites both locally and globally. InTemp allows for centralized cloud temperature data storage so that approved users and or Gateways can upload data from anywhere in the world and then access that data from a central location for advanced reporting and analytics. Organizations can also create one cloud account per site if they prefer a decentralized solution. Both types of setups can be customized and configured for seamless global cloud-based cold chain monitoring.

Using the CX5001 (Wi-Fi/Ethernet) or CX5500 (Cellular) Gateway to automatically program, start, and download loggers at a regular interval ensures continuous temperature recording for Cold Chain temperature monitoring. Configuring the Gateway to download and restart your temperature data loggers every 12 hours, every day, week, or month, will prevent the logger memory from filling up, create unique data sets for seamless compliance reporting, and enable a hands-off, automated solution for unparalleled ease of use.

If you are part of the Vaccines for Children program or are required to have a CDC-compliant data logger in general, then yes, you need to purchase a temperature data logger with a probe in glycol. If you are not part of the VFC program or required to maintain compliance with CDC guidelines, then generally you are not required to have a probe in glycol (please see country specific and local regulations for additional guidance). If your organization requires glycol bottle loggers, the general recommendation is to either go with the smallest available size (5ml) or mimic the size of the vaccines you are monitoring (Options of 5ml, 15ml, and 30ml bottles). Please be aware that the larger the glycol bottle, the more delayed a critical temperature excursion will be reported. Glycol bottle loggers are meant to prevent nuisance alarms from daily activities such as refrigerator door openings. They should not be used to dampen alarm response times. Configurable alarm settings can be programmatically added to the logger to meet product stability criteria instead of using glycol bottles.

InTemp performs a data logger calibration for all of its loggers and proudly maintains an ISO17025 accreditation. Details of an individual temperature sensor calibration can be found on the InTemp website. Additional or custom NIST test points can be added for an additional fee. Each order will come with a certificate of conformity and individual NIST calibration certificates can be downloaded from the InTempConnect cloud platform.

A certificate of conformity is sent with every order. In addition, you can retrieve an individual NIST calibration certificate from the InTempConnect cloud platform after you configure your logger the first time. Please refer to the InTempConnect User Guide for detailed instructions on how to download your NIST calibration certificate. If you are not using InTempConnect, you can contact our Customer Service department for a copy at [email protected]

Only the CX400 family of loggers are eligible for recalibration and can only be recalibrated up to 5 times (Or only one time for the CX402-VFC logger which comes with a 3 year NIST calibration certificate). To begin the process of recalibrating your loggers, fill out the forms on this webpage https://www.onsetcomp.com/intemp/recalibration-program

The CX402-VFC loggers come with a one of a kind logger swap out program for recalibration. Unlike traditional recalibration programs, InTemp will send you new loggers to use prior to you sending back your old loggers. This means you do not have to purchase additional loggers for backup while recalibration services are being completed! All other CX400 loggers are subject to the traditional recalibration program. Customers will send their loggers back for recalibration (average 2 weeks to complete) and will need backup loggers during that time to ensure continuous monitoring. Those loggers will then be sent back to you after the recalibration has been completed. See the above recalibration webpage for more details.

Yes, InTemp will send you a reminder email one month prior to the recalibration date.

No, the Gateway is not required to use the temperature data loggers however, it is highly recommended. The CX5000 family of Gateways enable valuable IoT temperature monitoring capabilities including:

• Automated temperature reporting for temperature monitoring compliance
• Real-time temperature alerts via text message and or email
• Remote temperature monitoring capabilities
• Automated temperature data logger management
• And more!

For storage applications such as vaccine storage monitoring, cold storage monitoring, and general pharmaceutical temperature monitoring, organizations can almost fully automate their compliance monitoring activities with the Gateways to significantly reduce costs and gain efficiencies around their Cold Chain monitoring.

Unfortunately InTemp does not offer on site services at this time. However, it does offer numerous customer support options including:

• Tech Support - Available 8am-8pm EST Monday-Friday
  https://www.onsetcomp.com/intemp/contact/support
• Easy to follow written guides
  https://www.onsetcomp.com/intemp/resources?f%5B0%5D=resource-type%3A1286
• How-To Videos
  https://www.onsetcomp.com/intemp/resources?f%5B0%5D=resource-type%3A86

Temperature data loggers can be started by using the InTemp mobile temperature monitoring app and or a CX Gateway. For detailed instructions, please use the InTemp System User's Guide.

Temperature data loggers can be started by using the InTemp mobile temperature monitoring app and or a CX Gateway. For detailed instructions, please use the InTemp System User's Guide.

Data is transferred from your digital data logger to the InTempConnect cloud platform through the InTemp mobile temperature monitoring app and or a CX Gateway. The mobile device or CX Gateway will connect to the logger via Bluetooth (Devices must be within 100ft/30.5m line of site of the loggers) to download the data from the logger. They will then upload the data to the cloud via a Wi-Fi or cellular connection. Note: You must sign into the InTemp mobile app using your InTempConnect cloud credentials in order for the data to be uploaded to your cloud account.

The CX400 family of temperature data loggers can be used for up to 6 years and are eligible for recalibration within those 6 years. After that timeframe, you cannot send in your loggers for recalibration and must purchase a new one.

The CX500, CX600, CX700, and CX1000 family of loggers all have a single-use and a multi-use option. The single-use option can be used only once within a one-year timeframe. The multi-use options can be used as many times as you would like for up to one year. These logger families are not eligible for recalibration.