Example Standard Operating Procedure (SOP)

This SOP servers as an example based around temperature monitoring applications, where NATA certification and 21CFR Part 11 compliance is required.
It is an example only, and may need to be modified for your specific application requirements.

1.1. Equipment

  • Dragino LHT65N Temperature and Humidity Sensor
  • Dragino LTC-LT/SI RTD Temperature Sensor
  • Dragino LPS8N LoRaWAN Gateway
  • Software: Telemetry2U (T2U) cloud-based interface, accessible at https://telemetry2u.com from any internet-connected device.

The sensors transmit temperature data to the gateway via a long-range radio link. The gateway then uploads this data to the cloud, making it accessible online.

1.2. NATA Temperature Calibrations

The temperature sensors have been sent to a NATA facility for 3-point calibration and/or verification to ensure accuracy. The NATA calibration certificates are available for download via Admin >> View Documents.

1.3. Annual Temperature Verifications

Annual temperature verification can be performed on-site and in-situ by trained T2U personnel using a NATA-traceable thermometer accompanied by a valid NATA certificate. A single-point check is typically performed at the operating temperature, with an offset applied and verified if necessary. A NATA-traceable calibration certificate is provided upon completion and is available for download via Admin >> View Documents.

1.4. Temperature Sensor Buffers

Where applicable, temperature sensors are fitted inside temperature buffers designed to reduce false alerts caused by defrosts or door-open events. These buffers also provide an accurate representation of the product being stored.

1.5. 21CFR Part 11 Compliance

T2U complies with FDA 21CFR Part 11 regarding record-keeping and digital signatures. When activated, only administrators with the CFR21 role assigned to their accounts can make significant changes to settings and configurations on T2U. Administrators must correctly enter their account password before saving changes on any relevant pages. For details about the applicable pages, refer to the 21CFR Part 11 Compliance link in Section 1.7. An audit report containing a log of all relevant changes can be downloaded from Audit >> Reports.

1.6. Procedures

The system provided by T2U is a cloud-based temperature monitoring solution designed to streamline real-time monitoring and auditing processes. It sends email, SMS, or voice alerts to users during any temperature fluctuations. All hardware is supplied in a plug-and-play format, eliminating the need for end users to physically connect to any devices for setup or configuration. Additionally, the T2U account is preconfigured with user accounts, real-time dashboards, alerts, and audit reports. As requirements change, users may need to modify settings.

1.6.1. Managing the LoRaWAN Gateway

End users cannot make critical changes to gateway settings that might cause it to go offline; however, some basic settings can be adjusted if needed.

  • Navigate to Admin >> Gateway Maintenance and click the Edit link next to the gateway of interest.
  • Modify the gateway's name in the Description field.
  • If the gateway goes offline, users will be notified via SMS. By default, a notification is sent if the gateway loses contact with the server for more than 5 minutes. The notification time and the notification group can be adjusted using the Notification Contact Minutes and Notification Group fields. To resolve a network disconnection, disconnect the power for 10 seconds and reconnect it. Users will receive another SMS notification when the gateway comes back online. If the issue persists, email support@telemetry2u.com for immediate assistance.
  • To check the gateway's connection status at any time, navigate to Admin >> Gateway Status. The Last Receive Time should always display Less than 1 minute.

1.6.2. Managing the LoRaWAN Temperature Sensor

End users cannot make critical changes to node settings that might cause them to go offline. However, some basic settings can be modified if needed.

  • Navigate to Admin >> Node Maintenance and click the Edit link next to the node (sensor) of interest.
  • Modify the node name in the Description field.
  • If a node goes offline, users will be notified via SMS. By default, a notification is sent if the node loses contact with the server for more than 65 minutes. The notification time and group can be adjusted using the Notification Contact Minutes and Notification Group fields. To reconnect a node that has dropped off the network, hold the reset button for 5 seconds. This will force the node to reconnect. Users will receive another SMS notification when the node comes back online. If the issue persists, email support@telemetry2u.com for assistance.
  • All nodes are equipped with internal memory. During any outage, temperature data is stored in memory. When the node comes back online, this data is automatically uploaded, ensuring no records are lost. In rare cases, data can be manually downloaded from memory by a T2U representative.
  • Commands can be sent to nodes to modify settings such as the update rate. To do this, navigate to Admin >> Send Node Commands. Select the node from the list, choose the desired command, and click Send. The command will be processed on the next uplink.

1.6.3. Inviting New Users to the Account

Administrators can add as many users to the T2U account as needed. Follow these steps to add new users:

  • Navigate to Admin >> User Maintenance and click the Create New User button at the top of the page.
  • Fill out the form as required. Ensure the email address and phone numbers are entered correctly under Notification Contact Details. Phone numbers must be entered in international format (e.g., +61xxxxxxxxx) to receive alert notifications.
  • Once the form is complete, click the Create button at the bottom of the page.
  • The new user will receive an email invitation to join the T2U account. This email contains a link to set a password and verify their details. Once verified, the user can log into their account. Note: Sensor data access must be configured before the user can view any data. See Section 1.2.4 for details.
  • Users can edit or delete their account settings at any time through the Account section in the main menu.

1.6.4. Configuring New and Existing User's Access and Controls

Administrators have complete control over all user accounts and can configure data access and general permissions as required. To edit a user's access:

  • Navigate to Admin >> User Maintenance and click the User Access Control link next to the user's row.
  • Use the checkboxes under the User Roles section to assign roles to the user. Each role is documented in T2U's Help section found in the top menu.
  • Specify which sensors the user can access under the Node Access Control section. If the All Nodes role is selected in the User Roles section, the user will have access to all nodes regardless of the specific selections here.
  • Click the Save button at the bottom of the page to apply changes.

1.6.5. Managing Notification Groups

Users must be added to notification groups to receive alert notifications. Notification groups consist of users and allow administrators to configure the type of notifications (email, SMS, or voice) and the times when notifications should be sent. You can create as many notification groups as needed.

  • Navigate to Admin >> Notification Group Maintenance.
  • Click Create at the top of the page to set up a new notification group, or use the Edit link next to an existing group to modify it. Assign or update the group name, then click Save at the bottom of the page.
  • Click on the Members link to configure user settings within the notification group.
  • Use the checkboxes to specify which users should receive alerts and the types of alerts they should receive.
  • Adjust the Day Range filter to determine which days each user should receive alerts. By default, alerts are set for all seven days.
  • Adjust the Time Range filter to set the time frame during which each user should receive alerts. By default, alerts are enabled 24/7.
  • Click the Save button to apply changes.

1.6.6. Configuring Alerts

Alerts can be configured on sensors to trigger notifications to notification groups under various conditions. Multiple conditions can be added to a single alert group.

  • Navigate to Admin >> Alert Maintenance.
  • Click the Create New Alert Group button at the top of the page to set up a new alert group, or use the Edit button next to an existing alert group to modify it.
  • Toggle the Active checkbox at the top of the page to enable or disable the alert group.
  • Provide a custom Description for the alert group and set the time range for when it should be active. By default, the group is active 24/7.
  • In the Include Notification Groups section, use the checkboxes to select which notification groups should receive alerts triggered by this group. Notifications are triggered for both out-of-range conditions and recovery by default, but recovery notifications can be disabled by unchecking the Send on Recovery box.
  • Add alert conditions by selecting a node from the list to include it in the conditions table.
  • Specify the Input for the condition, choose the Comparison method (e.g., greater than, less than), and enter the comparison Threshold.
  • Set the number of Consecutive Readings required to trigger the condition.
  • Use the Minutes Between Alerts field (default: 60 minutes) to set the minimum interval between repeated alerts for the same condition.
  • Toggle the Send on Recovery checkbox to enable or disable recovery notifications for the condition.
  • Toggle the Active checkbox to enable or disable the condition.
  • Click the Save button at the bottom of the page to apply changes.

1.6.7. Adding Annotations to Alert Events

After an alert is triggered and notifications are sent, users can log in to T2U and leave an annotation on the event. Annotations will then be included in the associated Audit Report(s). Users with the Add Annotations role assigned in their Access Settings (as described in Section 1.2.4) can create annotations.

  • Navigate to the Reports page from the top menu.
  • Select the node of interest from the drop-down menu and locate the record in the table where the alert event (or recovery) occurred. Records will be highlighted red for alerts and green for recoveries.
  • Click on the Warning icon to open the annotation page.
  • Enter the annotation details and click the Save button.
  • Annotations can be edited using the same process.

1.6.8. Creating and Editing Audit Reports

Audit reports can be configured to provide detailed information about sensors. These reports can be downloaded by any user via the Audit button in the top menu. Audit report settings also determine the limit lines displayed on the charts page.

  • Navigate to Admin >> Audit Report Maintenance.
  • Click the Create New Audit Report button at the top of the page to set up a new report, or use the Edit button next to an existing report to modify it.
  • In the top section, assign a Site Name, Report Name, and select the appropriate Time Zone.
  • Use the checkboxes to choose which Information to Include in the report. Hover over the help icons for a brief description of each option.
  • Add nodes to the table by selecting them from the Add Node dropdown menu. A node can be added multiple times if needed.
  • For each added node, select the Sensor Input and configure the Upper and Lower Limits for the charts.
  • Click the Save button at the bottom of the page when finished.

1.6.9. Email Audit Reports Automatically

Once an audit report has been created, it can be scheduled to be emailed automatically to users within a notification group by setting up a scheduled job.

  • Navigate to Admin >> Schedule Audit Reports.
  • Click the Create a New Job button at the top of the page to set up a new job, or use the Edit button next to an existing job to modify it.
  • Provide a Description for the job and select the Notification Group that should receive the audit report. Choose the audit report from the Item to Run field, and configure the scheduling details using the Run Frequency, Run On, and Run at Time fields.

1.6.10. Managing Dashboards

Dashboards provide users with a quick view of real-time data from their internet-connected devices. Any user with the Edit Dashboard role assigned in their Access Controls (as described in Section 1.2.4) can create dashboards.

  • When you first log in to T2U, you will be taken directly to the Dashboard page.
  • All users can select which dashboard they want to view using the Dashboard Selection field.
  • If a user has the Edit Dashboard role assigned, they will have access to additional options, including:
    • Buttons to create, rename, or delete dashboards.
    • Option to make a dashboard visible to all users by checking the Company Wide checkbox.
    • A button to toggle editing mode on and off.

1.6.11. Copy a Dashboard to Another User

Once a dashboard has been created, it can be copied to other users' accounts.

  • Navigate to Admin >> Copy Dashboard.
  • In the first Dashboard Name field, select the dashboard from your account that you want to copy.
  • Select the Person you want to copy the dashboard to using the second field.
  • In the last Dashboard Name field, assign a name for the copied dashboard and click the Copy button at the bottom of the page.
  • Note: If the new dashboard name already exists in the destination account, the existing dashboard will be overwritten and cannot be recovered.