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Friday, 02 January 2009 17:44

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.

Last Updated ( Tuesday, 03 November 2009 22:13 )
 

Welcome to the www.beyondedc.com website, where you will find pen-based electronic data collection solutions to your clinical trial data collection challenges. Mi-Forms data collection software and solutions automate paper collection processes via user-friendly handwritten electronic forms, reducing errors and costs and speeding up availability of data for review. Mi-Forms pen-based data collection solutions offer an easy, natural system for collecting electronic data immediately at the point of data generation, on-line or off-line. Mi-Forms for Tablet PC and Digital Pen provide powerful advantages over ordinary paper, traditional double-key and web-based data entry in eClinical applications such as Site Visit Reporting, Electronic Case Report Forms (eCRFs), Informed Consent Forms (ICFs), and Electronic Patient Reported Outcomes (ePRO). In addition, Mi-Forms solutions have been used to automate paper processes in pharmaceutical manufacturing quality assurance.



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

Mi-Co is a member of the Medidata Developer Central, an online developer community dedicated to users of the Rave Web Services API. The Medidata Rave Web Services API allows external systems such as Mi-Forms to be seamlessly integrated with market-leading Medidata Rave®, including inbound and outbound data sharing using CDISC* data standards. Please see http://www.mdsol.com/innovate/index.htm for more information.

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