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.
- Dragino LHT65N Temperature and Humidity Sensor
- Dragino LTC-LT/SI RTD Temperature Sensor
- Dragino LPS8N LoRaWAN Gateway
- Software: Telemetry2U (T2U) cloud-based interface found at https://telemetry2u.com and accessible from any internet-connected device.
The sensors send temperature data to the gateway via a long-range radio link. The gateway then passes this data to the cloud where it is made accessible online.
1.2. NATA Temperature Calibrations
The temperature sensors have been sent away to a NATA facility for a 3-point calibration and/or verification to ensure their accuracy. The NATA calibration certificates are available to 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 with a valid NATA certificate. A single point check is usually performed at the operating temperature with an offset applied and verified if required. A NATA traceable calibration certificate is provided upon completion and made available to download via Admin >> View Documents.
1.4. Temperature Sensor Buffers
Where applicable, temperature sensors have been fitted inside of a temperature buffer designed to reduce false alerts from defrosts and door open events as well as provide an accurate representation of the product being stored.
1.5. 21CFR Part 11 Compliance
T2U is compliant with the FDA 21CFR Part11 regarding record keeping and digital signatures. When activated, only administrators with the CFR21 roll assigned to their account can make major changes to settings and configurations on T2U. Their account password must be correctly entered before saving any changes on any relevant pages. Please refer to the 21CFR Part 11 Compliance link in section 1.7 for details on exactly what pages this applies to. An audit report containing a log of all relevant changes can be downloaded from the Audit section 1.6.8.
The system supplied by T2U is a cloud-based temperature monitoring solution designed to streamline real-time monitoring as well as the auditing processes. It will send e-mail, SMS, or voice alerts to users directly during any temperature fluctuations. All hardware has been supplied in plug-and-play format, so there is no need for end users to physically connect to any devices for setup and configuration. Additionally, the T2U account has been preconfigured with the setup of users, real-time dashboards, alerts, and audit reports. Moving forward, it may be required to modify settings.
1.6.1. Managing the LoRaWAN Gateway
It is not possible for end users to make critical changes to the gateway settings that may cause it to go offline, but some basic setting can be changed if desired.
- Navigate to Admin >> Gateway Maintenance and hit the Edit link to the right of the row of the gateway of interest.
- Change the name of the gateway in the Description field.
- If a gateway goes offline for any reason, users will be notified via SMS. By default, a notification will be sent if the gateway loses contact with the server for more than 5-minutes. Both the time and the notification group can be modified with the Notification Contact Minutes and the Notification Group fields respectively. In the rare event of a gateway dropping off the network, disconnect power for 10-seconds before reapplying. Users will receive another SMS notification when it comes back online. If the gateway does not come back online, please email email@example.com for immediate support.
- Check the status of the gateway connection at any time by navigating to Admin >> gateway Status. The last receive time should always be Less than 1-minute.
1.6.2. Managing the LoRaWAN Temperature Sensor
It is not possible for end users to make critical changes to the node settings that may cause them to go offline, but some basic setting can be changed if desired.
- Navigate to Admin >> Node Maintenance and hit the Edit link to the right of the row of the node(sensor) of interest.
- Change the name of the node in the Description field.
- If a node goes offline for any reason, users will be notified via SMS. By default, a notification will be sent if the node loses contact with the server for more than 65-minutes. Both the time and the notification group can be modified with the Notification Contact Minutes and the Notification Group fields respectively. In the rare event of a node dropping off the network, hold the reset button in for 5-seconds. This will force the node to reconnect to the network. Users will receive another SMS notification when it comes back online. If the node does not come back online, please email firstname.lastname@example.org for immediate support.
- All supplied nodes have an internal memory. During any outage, temperature data is stored to memory. When the node comes back online, temperature data is automatically polled from memory so no records will be lost. In extreme circumstances, data can be manually downloaded from memory, but this must be performed by a T2U representative.
- It is possible to send nodes commands to change settings like the update rate. To do so, navigate to Admin >> Send Node Commands. Select the node of interest from the list and then select the command before hitting the send button. Commands will be processed on the following uplink.
1.6.3. Inviting New Users to the Account
Assigned administrators can add as many users to the T2U account as required. The steps required to add new users are as follows:
- Navigate to Admin >> User Maintenance and hit the Create New User button at the top of the page.
- Complete the form as required. Make sure to correctly enter the email address and phone numbers under the Notification Contact Details section, otherwise, the user may not receive alert notifications. Phone numbers must be entered in international format, i.e., +61xxxxxxxxx.
- Once the form is completed, hit the Create button at the bottom of the page.
- The new user will receive an email with an invitation to join the T2U account. The link will take the new user to a page where they can create a password and verify their details. Once this is complete, the new user will be able to log into their account. They will not yet have access to any sensor data until their user access has been configured. Please refer to section 1.2.4.
- Users can edit or delete their account settings at any time under the Account section in the main menu.
1.6.4. Configuring New and Existing User's Access and Controls
Administrators maintain complete control over all user accounts and can configure their data access and general accessibility as required. To edit a user's access:
- Navigate to Admin >> User Maintenance and hit the User Access Control link to the right of the user's row.
- Use the check boxes under the User Roles section to assign any roles you want the user to have. Each role is documented in T2U's Help section found in the top menu.
- Check which sensors each user will have access to under the Node Access Control section. If the All Nodes role has been checked in the User Roles section, the user will have access to all nodes, regardless of what is checked here.
- Click the Save button at the bottom of the page.
1.6.5. Managing Notification Groups
Users need to be added to notification groups before they will receive any sort of alert notifications. Notification groups consist of users, and you can configure what type of notifications (email, SMS, and voice) as well as what time individual users receive notifications. Create as many notification groups as required.
- Navigate to Admin >> Notification Group Maintenance.
- Use the button at the top of the page to Create a new notification group or use the Edit link to the right of the notification group row to modify an existing one and assign/modify the group name before hitting the Save button at the bottom of the page.
- Click on the Members link to configure the notification groups user settings.
- Use the check boxes to set which users should receive alerts as well as what type of alerts they receive.
- Use the Day Range filter to set what days each individual user should receive alerts. It will be 7-days a week by default.
- Use the Time Range filter to set what time each individual user should receive alerts. It will be 24/7 by default.
- Click the Save button at the bottom of the page.
1.6.6. Configuring Alerts
Alerts can be configured on sensors that trigger notifications (to notification groups) under various conditions. You can add many conditions to a single alert group.
- Navigate to Admin >> Alert Maintenance.
- Use the Create New Alert Group button at the top of the page to create a new alert group or use the Edit button to the right of an existing alert group row to modify one.
- You can turn the Alert group on and off with the Active checkbox at the top of the page.
- Give the group a custom Description and select the time range the group should be active. By default, it will be set for 24/7.
- Use the checkboxes to select which Notification Groups will be triggered from alert conditions in the Include Notification Groups section. By default, a notification will be triggered when sensors both fall outside of conditions and recover, but you can turn recovery notifications off by unchecking the Send on Recovery box.
- To add an alert condition, select a node from the list to add it to the conditions table.
- Select which Input the condition should apply to and pick which Comparison method should be used (greater than, less than, etc.) along with the comparison Threshold.
- Set how many Consecutive Readings need to be out of range before the condition is triggered.
- The Minutes Between Alerts (default 60) sets the minimum period an alert condition will trigger.
- Use the Send on Recovery check box to set if that condition will trigger a recovery message or not.
- Use the Active check box to turn the condition on or off.
- Hit the Save button at the bottom of the page after making any changes.
1.6.7. Adding Annotations to Alert Events
Once an alert has been triggered and notifications sent, users can log in to T2U and leave an annotation on the event and the annotation will then be made available in the Audit report(s). Any users with the Add Annotations role assigned in their Access Settings (as described in section 1.2.4.) can leave annotations.
- Navigate to the Reports page from the top menu.
- Select the node of interest from the drop-down box and locate the record within the table where the alert event (or recovery) occurred. It will be colored red for alert or green for recovery.
- Click on the Warning icon to open a new page where you can leave the annotation.
- Click the Save button when complete.
- Annotations can be edited by any users using the same process above.
1.6.8. Creating and Editing Audit Reports
Audit reports can be configured to contain detailed information about sensors. Audit reports can be downloaded by any user via the Audit button in the top menu. Audit reports settings will configure the limit lines on the charts page.
- Navigate to Admin >> Audit Report Maintenance.
- Use the Create New Audit Report button at the top of the page to create a new audit report or use the Edit button to the right of an existing audit report row to modify one.
- In the top section, give the Audit report a Site Name, Report Name, and select the correct Time Zone.
- Use the check boxes to select what Information to Include in the audit report. Click on the help icons for a brief description of each function.
- Add nodes to the table by selecting it from the Add Node selection field. The same node can be added multiple times as required.
- Once the node is in the table, select the Sensor Input as well as the Upper and Lower Limits.
- Hit the Save button at the bottom of the page when complete.
1.6.9. Email Audit Reports Automatically
Once an audit report has been created, it can be scheduled to be emailed to users within a notification group automatically by setting up a scheduled job.
- Navigate to Admin >> Schedule Audit Reports.
- Use the Create a New Job button at the top of the page to create a new job or use the Edit button to the right of an existing job row to modify one.
- Give the job a Description and select which Notification Group should receive the audit report. Select the audit report from the Item to Run field and pick the Run Frequency, Run On, and Run at Time fields to configure when the email should be sent.
1.6.10. Managing Dashboards
Dashboards provide a way for users to quickly see real-time data from their internet-connected devices. Dashboards can be created by any user with the Edit Dashboard user role assigned in their Access Controls as described in section 1.2.4.
- When first logged into T2U, you'll be taken straight to the Dashboard page.
- All users can select which dashboard they want to view with the Dashboard selection field.
- If the user has the Edit Dashboard role assigned, they will have some extra options.
- Buttons to create, rename or delete dashboards.
- The ability to make a dashboard visible to all users via the Company Wide checkbox.
- A button to toggle editing mode on and off.
1.6.11. Copy a Dashboard to Another User
Once you have created a dashboard, you can copy that dashboard to other user's accounts.
- Navigate to Admin >> Copy Dashboard.
- The first Dashboard Name field will have a list of all the dashboards under your account. Select which dashboard you want to copy.
- Select the Person you want to copy the dashboard to in the second field.
- Use the last Dashboard Name field to name the new dashboard and hit the Copy button at the bottom of the page.
- If you copy a dashboard with a name that already exists, the old dashboard will be overwritten and cannot be recovered.
1.7. Further Reading
- Telemetry2U Quick Guide.
- Telemetry2U Comprehensive Guide.
- Telemetry2U 21CFR Part 11 Compliance.