CUKA supports the execution and documentation of calibration orders on laboratory measuring devises, instruments and clean room equipment.
CUKA primarily targets the calibration process required by pharmaceutical manufacturers. It meets the requirements of the U.S. Food and Drug Administration (FDA) for computerized systems for storing electronic records (21 CFR Part 11-Electronic Records and Signatures Rule).
The calibration workflow completes with the output of complex reports. Generated documents are subject to electronic signatures.
The calibration itself is performed offline using the POKAS system. It is installed on several mobile devices. These gadgets will be carried on-site by technicians after calibration data and SOPs have been downloaded. POKAS supports both automatic data acquisition and manual data entry. Both kind of data is evaluated according to predefined algorithms and compared against given limits. Finally, processed orders are uploaded again to the main system.
The system furthermore uses collected data for monitoring the quality and long-term stability of the hardware components used by the calibration process. Statistics may suggest information about faulty behavior.
