Device Checks — §11.10(h)

Device Checks. The system shall employ device checks, as appropriate, to determine the validity of the source of data input or operational instruction, in accordance with §11.10(h). Device checks are controls designed to verify that data originates from an authorized and properly functioning source, particularly when data is automatically captured from instruments, equipment, or external systems. The following device checks shall be implemented where applicable: (a) verification of the identity and status of connected instruments, equipment, or devices prior to accepting data input (e.g., confirming that a laboratory instrument is within its calibration validity period before accepting test results); (b) validation of communication protocols and data integrity checks (e.g., checksums, cyclic redundancy checks, or digital signatures) for data transmitted between systems or devices; (c) verification that the data format, range, and type received from a device are consistent with expected values, and rejection or flagging of data that falls outside acceptable parameters; (d) authentication of the source system or device when receiving data from external or networked sources; (e) logging of all device-generated data inputs, including the device identifier, timestamp, and the identity of the operator (if applicable); and (f) all device check configurations and their effectiveness shall be verified during system validation and documented in the validation package.