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deltaDOT achieves CFR21 compliance for FDA’s data requirements

publication date: Feb 20, 2017
author/source: deltaDot


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.

The 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.

Nigel Stokes, deltaDOT’s Managing Director commented: “We have worked for over 6 months on software validation relating to the CFR standard. The aim of the exercise was to ensure our clients' needs to comply with the regulations were met and to ensure all data produced by the system could be properly validated. This is a neccessary step in any Quality Management System which may be in place to control future changes to the software. We are very pleased that this work was completed on time and within budget.”

Dr Stuart Hassard, deltaDOT’s Chief Scientific Officer added that “With these new software tools we are enabling the use of our technology throughout the bioprocess, and are allowing our clients to make higher quality products using our cost effective process analytical technology. Recent advances in monoclonal, biosimilar and gene therapy viral vector characterisation have greatly increased the range of valuable applications which our instruments can address.”
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