NEW KODAK Molecular Imaging Software,
Regulatory Edition

Introducing our Regulatory Edition of Molecular Imaging (MI) Software for use in digital imaging systems for life science research and drug discovery applications. The Regulatory Edition package supports compliance with U.S. Food and Drug Administration’s Code of Federal Regulations Title 21, Part 11 Electronic Records; Electronic Signatures [21 CFR Part 11].

KODAK MI Software, Regulatory Edition has all the features of MI Software with added tools and advanced CFR security features. Original raw data files are maintained and securely preserved, and a complete audit trail of file modifications is continuously tracked. The versatile package also includes a web-based application interface that enables any number of users worldwide to collaborate, search image databases, and share data and analysis results from any computer on the Internet.

System Requirements Ordering Information MI Software

• Security Manager provides easy to use interface for setting up accounts, permission levels, projects and studies
• User login screen launches application; multiple failed logins disables the account
• Accommodates multiple user groups with different levels of authority
• Manages multiple projects and studies
• Requires password re-entry when idle after a specified time

• Seamlessly integrated within KODAK MI software and KODAK in vivo and in vitro imaging systems
• Intuitive controls for submitting, reviewing and approving electronic records
• E-mail notifications for management approvals

• Copies of the original raw data file are maintained and preserved
• Complete audit trail of any changes made to the file, including User ID, time and date
• Read/write protected files and electronic signatures as specified by 21 CFR Part 11
• MD5 TIFF file validation certifies image integrity - detects changes after files have been exported from MI

• Cross platform- supports Macintosh and Windows users
• Upgradeable from current KODAK 1D or MI software versions

KODAK Molecular Imaging Software contains integrated interfaces for KODAK Image Station and Gel Logic cameras. In addition, MI Software contains a TWAIN driver for convenient image acquisition using TWAIN-compliant scanners and cameras. In addition, MI Software is compatible with TIFF and JPEG image files captured using other imaging devices. MI Software’s n-bit file format capability and floating point data utilize all image file data.