21 CFR Part 11 Compliance

Compliance statement

Cydiance C0, C1, B3, B5, and R3 temperature monitoring devices are designed to support FDA 21 CFR Part 11 requirements for electronic records in cold-chain applications.

Use of a Cydiance product that supports 21 CFR Part 11 does not by itself make the customer or the customer's system compliant. It remains the customer's responsibility to integrate the product into Standard Operating Procedures (SOPs) and to validate the overall system so that it meets applicable regulatory requirements when audited.

21 CFR Part 11 applies when predicate rules require records to be maintained electronically. Customers should determine applicability with their quality and regulatory advisers. See FDA guidance on Part 11 scope and application.

Cydiance product features relevant to Part 11

Electronic records

1. Electronic data and charts are human-readable and suitable for inspection and review.
2. All data includes date and time stamps.
3. The system supports valid, calibrated data input.
4. The system is designed to prevent data input from non-validated sources on the device.

Data storage and integrity

1. Generated data is stored in a protected on-device or platform storage area, as applicable to the product.
2. R3 uploads trip data to the cellular cloud platform and maintains a local on-device backup of recorded data to support audit and independent verification.
3. Generated data is not editable or alterable by the user through normal device operation (integrity controls apply).
4. Parameter and calibration context can be documented to show how results were achieved (e.g. method and equipment used, including model, version, or serial number where applicable).
5. The system supports identification of invalid or out-of-specification results (e.g. alarms and limit excursions where configured).

Electronic signatures and system access

Cydiance C0, C1, B3, and B5 field loggers operate without on-device user login or password.

R3 uploads trip data to the cloud during transit and retains a local data backup on the device for audit purposes. Like the loggers above, R3 has no on-device user login; authenticated review and approval are expected at the system level.

Electronic signatures are not implemented on the logger or tracker hardware itself.

Customers must define SOPs for authenticated review and approval of records — for example controlled export, review in a validated platform, and documented sign-off — so that audit requirements for electronic signatures are met at the system level.

System-level controls (customer and platform)

A complete 21 CFR Part 11 environment typically also requires controls that sit outside the field device, such as:

• Access control and unique user identification (§ 11.10(d), (f))
• Audit trails for changes to electronic records in validated systems (§ 11.10(e))
• Record retention and retrieval for the full retention period (§ 11.10(c))
• Accurate copies for inspection (§ 11.10(b))
• System validation (§ 11.10(a))

The Vista web platform is being developed to support multi-device shipment management, data analysis, and operational controls. Customers planning Part 11 deployments should map logger, app, and platform responsibilities in their validation documentation.

Conclusion

Cydiance C0, C1, B3, B5, and R3 are intended to be integrated into the customer's validated quality system and SOPs as components of a 21 CFR Part 11–capable cold-chain monitoring solution. All regulated systems must be independently validated and audited by the customer. The features above provide a technical basis to support compliance; they do not replace customer validation or quality system obligations.

For deployment questions, contact support@cydiance.com.