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Advanced Cell Technology, an Innovative Biotech Company, Chooses MasterControl to Help Facilitate FDA Compliance
SALT LAKE CITY Feb. 8, 2007 MasterControl Inc. today announced that Advanced Cell Technology, a biotechnology company specializing in embryonic stem cell application in the field of regenerative medicine, has chosen the MasterControl software solution to help facilitate compliance with FDA regulations.
Advanced Cell Technology, which has facilities in California and Massachusetts, own or license more than 300 patents and patent applications related to regenerative medicine and stem cell therapy. Advanced Cell Technology is focused on bringing various cell therapies into FDA-regulated clinical trials.
Advanced Cell Technology, which takes pride in its cGMP cell production facility, chose MasterControl because of its compliant features, cost-effectiveness, and extensive validation documentation, according to Linda Lemieux, director of quality systems for Advanced Cell Technology.
?Because of our cGMP-compliant manufacturing and plans for clinical trials, we need a compliant electronic document management system that would also give us greater control, efficiency, and cost savings. We need to be compliant with the regulations, and we need to ensure we spend money wisely,? said Lemieux.
Advanced Cell Technology chose MasterControl Documents?, the core application in the MasterControl integrated quality management suite, with a plan to add more modules over time. The company expects significant benefits from its new system. ?MasterControl will help ensure documentation system compliance, decrease document review and approval time, and add efficiency that will save us money in personnel time for years to come,? said Lemieux. MasterControl's comprehensive validation documentation included in the Validation Toolkit that was purchased with the system will also help the company save time and money in validating the new system.