MELVILLE, NY, June 2003 – In 1997, the Food and Drug Administration issued 21 CFR Part 11, the Final Rule on Electronic Records and Electronic Signatures. Part 11 applies to all electronic records that are created, modified, maintained, archived, retrieved, or transmitted in companies or departments that work under any kind of FDA regulation, as well as records submitted to the agency under the requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. Although the FDA has since published a new draft guidance document stating that it intends to reexamine Part 11 and interpret it narrowly, electronic records must still be maintained and submitted in accordance with the underlying FDA predicate rules.
Digital images and data fall into the category of records subject to this regulation. OLYMPUS AMERICA, in partnership with Soft Imaging Systems Corp. and BioMedion, offers a 21 CFR Part 11-compliant solution for the Olympus MicroSuite™ Software for microscopy and digital image acquisition.
Interfaced with the Olympus MicroSuite™ image analysis software, the BioMedion-Windream solution is a client-server based electronic data and document management system that provides all of the required functionality of 21 CFR Part 11 compliance in a Windows® (95 to XP) environment. All applications that run under Windows® and all connected hardware devices (such as microscopes and other laboratory equipment) can be deemed compliant to GxP and 21 CFR Part 11, as long as the required policies, standard operating procedures (SOPs), and validation are in place in the user’s laboratory. The compliant software features seamless integration with image acquisition and analysis, client/server-based data management, full computer-generated audit trails, validated time stamps, version control of all files, advanced user access management, electronic long-term archive option, document life cycle management, and electronic signatures (optional).
To learn more about the Olympus 21 CFR Part 11 compliant imaging software™ click here. Or you may contact: Olympus America Inc., 2 Corporate Center Drive, Melville, NY 11747; Phone: 1-800-455-8236; E-mail: firstname.lastname@example.org; or visit our website at www.olympusamerica.com/microscopes.
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