Kodak introduces new Regulatory Edition of Molecular Imaging Software to Support Compliance with FDA Regulations

Kodak introduces new Regulatory Edition of Molecular Imaging Software to Support Compliance with FDA Regulations

Eastman Kodak Company’s Molecular Imaging Systems group announced the release of a new Regulatory Edition of their KODAK Molecular Imaging (MI) analytical software for use in digital imaging systems for life science research and drug discovery applications. The Regulatory Edition 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].

The KODAK MI Software, Regulatory Edition can be easily integrated with any laboratory information system to archive images and support user authentication, data management, change logging, digital signatures and other security features to assist users with 21 CFR, Part 11 compliance. A security manager function makes setting up accounts, permission levels, projects and studies seamless. Original raw data files are maintained and securely preserved, and a complete audit trail of file modifications is continuously tracked. Furthermore, user workflow is enhanced through advanced controls for submitting and approving electronic records, such as email notifications for management approvals. The versatile software 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.

The software is compatible with all Kodak’s Molecular Imaging in vitro and in vivo systems as well as TIFF and JPEG image files captured using other imaging devices. It also supports both WINDOWS and MACINTOSH platforms and can be used in a networked environment. The KODAK MI Software, Regulatory Edition extends Kodak’s portfolio of analytical software and is available worldwide.

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