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deltaDOT Ltd.

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  deltaDOT achieves CFR21 compliance for FDA’s data requirements

deltaDOT High Performance Capillary Electrophoresis HPCE-512 instrument control and analysis software has now achieved compliance with CFR 21 part 11 of the US Food and Drug Administration.

deltaDotThe software suite contains controls to meet stringent requirements of CFR 21 part 11, including prevention of unauthorised system access, maintainance of audit trails of user actions, generation of complete and protected data files and electronic signatures applied to data.