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Mi-Co’s Mi-Forms Validated for FDA Regulation 21 CFR Part 11 Compliance


RESEARCH TRIANGLE PARK, NC, JAN. 24 – Mi-Co, the mobile data capture software company, announced that its Mi-Forms e-forms system has been validated for compliance with FDA Regulation 21 CFR Part 11 governing software used in clinical trials. Pharmaceutical firms, medical device manufacturers, drug testing companies and others involved in clinical trials can now experience the power of electronic data capture through the Mi-Forms system for time savings and management of vast amounts of data.

Mi-Co’s Mi-Forms software allows companies to reduce or eliminate paper forms in mobile environments for faster data capture and access, better data accuracy and business process efficiencies. Validation, according to 21 CFR Part 11, means the Mi-Forms software has been developed, tested and documented according to a rigorous methodology. Paper case report forms can now be replaced with a complete electronic forms solution which accepts handwritten data.

“Mi-Co is an important component of our Smart Pen solution,” said Rick Farris, Chief Operating Officer of HealthDecisions, a noted contract research organization. “Mi-Forms is a powerful tool for companies that must meet stringent data requirements.”

Mi-Co has become a recognized technology partner for many healthcare, government, field service and financial and insurance companies. Mi-Forms software, used in conjunction with digital pens, tablet PCs and other mobile devices has saved CROs, hospitals and home health organizations like Children’s Hospital Boston, Sutter Health System and University of North Carolina hundreds of thousands of hours while delivering more accurate data.

About Mi-Co

Mi-Co, the mobile data capture software company, provides digital writing software that enables efficient, effective data capture and communication from handwritten source documents. Mi-Co’s enterprise Mi-Forms Software System enables flexible e-forms design for data capture using digital ink and provides handwriting interpretation, touch-screen input, verification, data validation and communication of forms-based data for enterprise users. Mi-Forms supports tablet PCs, UMPCs, digital pens, pocket PCs and signature capture devices. Mi-Co is headquartered in Research Triangle Park, NC, with a customer service center in Seattle. For more information on Mi-Co, visit www.mi-corporation.com.

 
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