Transit History & Exception Monitoring
AVANTE Cold Chain Monitoring Services greatly reduce common supply chain challenges
- Cargo theft from containers and trailers via all six sides of the container, not just the tail doors
- Spoilage due to unwanted temperature variation (high or low)
- Geo-fencing and route conformance monitor in real time in case of potential diversion issues
- Denied claims for shock damage during handling, as accurate logs are maintained
- Customs and Border Protection concerns regarding tampering
- Continuous radiation monitoring to enhance Homeland Security (optional)
A user-friendly, easy to learn, yet powerful web-based interface allows for simultaneous reporting to multiple authorized stakeholders anywhere in the world. Additional features include:
- Route geo-fencing
- Driver/vehicle association & permissions
- Extended absence alerts
- End-to-end transit history
- Situational awareness & response management through logged alert acknowledgment
- Step-by-step playback of the complete transit history
- Full historical archives
- Alerts are sent via text message, email or phone. Alerts are real-time rather than only after the fact.
- Web-based solution with an easy-to-use interface is designed to easily integrate with your existing management.
REAL-TIME ACTIONABLE ALERTS OF TEMPERATURE, MOISTURE AND/OR SHOCK EXCEPTIONS BACKUP WITH WIRELESS DOWNLOADABLE AUDITABLE TRANSIT HISTORY RECORDING
In addition to real-time reporting of temperature, moisture and/or shock exceptions that may pose damage or loss to the cold chain shipment, data is stored in the ZONER-CTID device as part of the audit trail. The following are some of the distinct advantages of the AVANTE Cold Chain Monitoring Solution and Services:
- All data is encrypted and hashed to ensure data integrity and privacy. More than 60,000 records of data are stored in cyclic memory for wireless download.
- Data reflects the actual conditions of the cold chain being shipped (not just the specific temperature measurement point of the box) when ZONER-CTID devices are placed with the products either in pallet or box level.
- Data includes date-time that may be tracked with real-time alerts and periodic data that has been transmitted via the GPRS and/or satellite communications.
- When combined with the RELAYER data that is also retrievable for audit, a complete holistic picture of the shipment record is unparalleled for its accountability including GPS locations of all data, the association and proximity of drivers and other transportation staff related to the shipment.
- Provides auditable compliance with Federal and State guidelines.
|21 CFR Part 11 and the Cold Chain Management|
|System Validation, Training & Documentation||AVANTE SOLUTION|
|11.10 (a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.||The software and hardware vendor(s) should produce a detailed validation package that includes the features designed in the system and evidence that those features function appropriately. The hardware and software vendor(s) should maintain a controlled environment for product development in which procedures are developed, routinely followed and regularly audited.||
|11.10 (i) Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.||When selecting a temperature monitoring system ensure that the vendor(s) developers are properly trained in the relevant technologies and regulations (i.e., 21 CFR Part 11) related to the system. The vendor(s) should provide training for the system users and provide a detailed user manual describing system functionality. The vendor(s) should also maintain a Technical Support function that users can contact for support.||
|11.10 (j) The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification.||The customer organization should provide procedures and controls outlining for the users what an electronic signature represents in the system. In addition, the customer organization should provide information on the recourse for signature falsification.||
|11.10 (k) Use of appropriate controls over systems documentation including:
1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.
2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and; modification of systems documentation.
|The vendor should provide documentation such as validation packages and user manuals. These documents should be maintained as part of the customer’s document management system and controlled accordingly.||
|System Access and Security||AVANTE SOLUTION|
|11.10 (d) Limiting system access to authorize individuals.||Access to the temperature monitoring system should be limited to authenticated users only. The vendor should provide functionality for user administration including system access and activities the users has available to them.||
|11.10 (g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.||The temperature monitoring system should restrict access to activities via Username and Password. The vendor should provide functionality ensuring that access to data is secure and prevent unauthorized access. For web applications, the vendor should provide data encryption such as Secure Sockets Layer (SSL) at 128-bit encryption.||
|Record Readability and Data Source||AVANTE SOLUTION|
|11.10 (b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records.||The vendor should provide functionality to print temperature data and related meta-data. In addition, the temperature data should be available for electronic export into a common readable file such as XML or .xls format.||
|11.10 (h) Use of device (e.g. terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.||The vendor should provide controls to ensure that data entered into the system is from a valid source and in the correct format. If certain steps should be performed before others, the application should control the sequence of steps.||
|Data Retention and Backup||AVANTE SOLUTION|
|11.10 (C) Protection of records to enable their accurate and ready retrieval throughout the records retention period.||The type of temperature monitoring system dictates who is responsible for record retention. For a Client/Desktop system that relies on local storage on the PC, the customer must ensure that data is being backed up regularly and that data is readily retrievable upon request. The computer environment should be secure and maintained to prevent catastrophic failures in which data may be lost. For Web-Based Central Repository systems, the vendor shall provide a secure environment in which time/temperature and shipment data will be stored. Some solutions may include hardened Data Centers that provided guaranteed up-time and high Quality of Service (QoS).||
|Signature/Record Linking||AVANTE SOLUTION|
|11.50 (a) Signed electronic records shall contain information associated with the signature that clearly indicates all of the following:
1) The printed name of the signer;
2) The date and time when the signature was executed; and
3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.
11.50 (b) The items identified in paragraphs a1; a2 and a3 of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout).
11.70 Electronic signatures and handwritten signatures applied to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.
|The vendor shall provide functionality that captures the full name corresponding to the electronic signature, the date and time the signature was executed and the meaning of the signature. An electronic signature would be used to sign the shipment disposition (i.e., accepted or rejected).||