21 CFR Part 11 Compliance

21 CFR Part 11 Compliance Statement

Cydiance C0, B3, B4 are built to comply with FDA 21 CFR Part 11.

However, we must clarify that using a product from Cydiance that is compliant with 21 CFR Part 11, does not mean that the customer or the customer’s system/environment will be compliant. It is always the responsibility of the customer to integrate the product into their Standard Operating Procedures (SOPs) and perform satisfactory validation of the system to ensure that when audited, it complies.

Cydiance features for 21 CFR Part 11 Compliance

Electronic Record

1. Electronic data and charts are human-readable and suitable for inspection and review

2. All data includes date and time stamp

3. The system ensures data input is valid and calibrated

4. The system does not allow data input from non-validated sources

Data Storage

1. Generated data stored in the protected drive

2. Generated data shall not be edited or altered(encrypted)

3. Parameter results to see how they were achieved, e.g. method and equipment used, including model, version or serial number

4. Identification of invalid results – alarms etc

Cydiance C0, B3, B4 are electronic devices with no user login/password feature, and an electronic signature is not included in these systems. Customers shall imply its own SOPs to ensure authenticated signatures are included for audit.

In conclusion, the Cydiance product designated as 21 CFR Part 11 is designed to be integrated into the customers’ SOPs as part of a 21 CFR Part 11 system.

All 21 CFR systems must be independently audited, the above features from the Cydiance products provide an excellent basis for complying with 21 CFR Part 11.