Food Safety
search
cart
facebook twitter linkedin
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Food Safety
  • NEWS
    • Latest News
    • White Papers
  • PRODUCTS
  • TOPICS
    • Contamination Control
    • Food Types
    • Management
    • Process Control
    • Regulatory
    • Sanitation
    • Supply Chain
    • Testing and Analysis
  • PODCAST
  • EXCLUSIVES
    • Food Safety Five Newsreel
    • eBooks
    • FSM Distinguished Service Award
    • Interactive Product Spotlights
    • Videos
  • BUYER'S GUIDE
  • MORE
    • ENEWSLETTER >
      • Archive Issues
      • Subscribe to eNews
    • Store
    • Sponsor Insights
  • WEBINARS
  • FOOD SAFETY SUMMIT
  • EMAG
    • eMagazine
    • Archive Issues
    • Editorial Advisory Board
    • Contact
    • Advertise
  • SIGN UP!
Products

Shimadzu's Fluorescence Spectrometers Now Compliant with FDA's Electronic Signature Regulation

August 5, 2015

Shimadzu Scientific Instruments announces that its EDX-7000/8000 energy dispersive x-ray fluorescence spectrometers are now compliant with the 21 CFR Part 11 electronic signature regulation designated by the U.S. Food and Drug Administration (FDA). The Part 11 compliancy confirms that the electronic records produced by Shimadzu’s EDX-7000/8000 are trustworthy and reliable for use in the pharmaceutical and food industries. It also confirms the reliability of other key instrument features needed for industries--including security, user’s rights management, validation, and operation and audit trail output.

The EDX-7000/8000 features a secure user authentication and screen lock function that allows only authorized users access to the system. Login information is also recorded in a secure operational history log. The instrument’s audit trail log function allows users to quickly and easily output audit trail logs, including instrument setting change history and user operation history.

The FDA put into effect 21 CFR Part 11 in 1997. This regulation defines the criteria under which electronic records and electronic signatures are considered to be equivalent to records and signatures on paper. It applies to pharmaceutical and food companies that perform business activities in the U.S., companies that supply products or raw materials to these companies, (including exporting) and laboratories that receive contracted analysis from these companies.

Shimadzu | Shimadzu.com

 

 

 


Author(s): Staff

Share This Story

Looking for a reprint of this article?
From high-res PDFs to custom plaques, order your copy today!

Recommended Content

JOIN TODAY
to unlock your recommendations.

Already have an account? Sign In

  • people holding baby chicks

    Serovar Differences Matter: Utility of Deep Serotyping in Broiler Production and Processing

    This article discusses the significance of Salmonella in...
    Food Type
    By: Nikki Shariat Ph.D.
  • woman washing hands

    Building a Culture of Hygiene in the Food Processing Plant

    Everyone entering a food processing facility needs to...
    Food Prep/Handling
    By: Richard F. Stier, M.S.
  • graphical representation of earth over dirt

    Climate Change and Emerging Risks to Food Safety: Building Climate Resilience

    This article examines the multifaceted threats to food...
    International
    By: Maria Cristina Tirado Ph.D., D.V.M. and Shamini Albert Raj M.A.
Subscribe For Free!
  • eMagazine Subscription
  • Subscribe to eNewsletter
  • Manage My Preferences
  • Website Registration
  • Subscription Customer Service

More Videos

Sponsored Content

Sponsored Content is a special paid section where industry companies provide high quality, objective, non-commercial content around topics of interest to the Food Safety Magazine audience. All Sponsored Content is supplied by the advertising company and any opinions expressed in this article are those of the author and not necessarily reflect the views of Food Safety Magazine or its parent company, BNP Media. Interested in participating in our Sponsored Content section? Contact your local rep!

close
  • Two men standing in a produce storage facility having a discussion.
    Sponsored byOrkin Commercial

    Staying Compliant With FSMA

  • Deli Salads
    Sponsored byCorbion

    How Food Safety is Becoming the Ultimate Differentiator in Refrigerated and Prepared Foods

Popular Stories

Image of produce being washed on a conveyor belt in a facility

Science in Action: How Nanobubbles Are Advancing Food Safety Standards

FoodSafetyMattersFinal-900x550-(002).jpg

Ep. 195. Dr. Christopher Daubert: The Value of a Food Science Education

Students returning their lunch trays in a cafeteria

California Bill Would Remove Ultra-Processed Foods from School Lunches

Events

June 26, 2025

How to Design and Conduct Challenge Studies for Safer Products and Longer Shelf Life

Live: June 26, 2025 at 2:00 pm EDT: During this webinar, attendees will learn how to conduct challenge studies for microbial spoilage and pathogen growth, including the common challenges encountered, laboratory selection, and use of predictive models.

May 11, 2026

The Food Safety Summit

Stay informed on the latest food safety trends, innovations, emerging challenges, and expert analysis. Leave the Summit with actionable insights ready to drive measurable improvements in your organization. Do not miss this opportunity to learn from experts about contamination control, food safety culture, regulations, sanitation, supply chain traceability, and so much more.

View All

Products

Global Food Safety Microbial Interventions and Molecular Advancements

Global Food Safety Microbial Interventions and Molecular Advancements

See More Products
Environmental Monitoring Excellence eBook

Related Articles

  • Lab M’s Products are Now Compliant with ISO 11133:2014

    See More
  • exxonmobil signature polymers logo

    ExxonMobil Signature Polymers Partners With Colombian Company to Produce Packaging Solution for Local Meat Industry

    See More
  • Shimadzu Announces New Electron Capture Detector With Contact-Free Technology

    See More

Related Directories

  • CEJN North America

    High-performance F&B equipment for food safety, washdown and blow-off applications, and, now, introducing the First Metal/X-Ray-Detectable Plastic blow gun on the market- the 208 Detect- made from food grade plastic, reducing the risks of accidental contamination, product rejections, expensive recalls, and waste. Made from food-grade, detectable plastic, 208 Detect and in compliance with Reg. (EC) No 1935/2004 and FDA CFR 21.170-199.
  • Altech Corp.

    Altech Corporation is an established USA supplier of components and devices used in industrial control, instrumentation and automation. They are an ISO 9001:2000 certified supplier of electrical, electronic and electromechanical components. Altech also provides custom assemblies.
  • MPI - Magnetic Products Inc.

    Based in Metro-Detroit Michigan since 1981, MPI designs, manufactures, and services industrial magnets, material handling, and electronic inspection systems. Visit www.mpimagnet.com to see how MPI can help you achieve your food safety plan and minimize the risk of a product recall by providing best-practice know-how and equipment to detect and remove metal contaminants.
×

Never miss the latest news and trends driving the food safety industry

eNewsletter | Website | eMagazine

JOIN TODAY!
  • RESOURCES
    • Advertise
    • Contact Us
    • Directories
    • Store
    • Want More
  • SIGN UP TODAY
    • Create Account
    • eMagazine
    • eNewsletter
    • Customer Service
    • Manage Preferences
  • SERVICES
    • Marketing Services
    • Reprints
    • Market Research
    • List Rental
    • Survey/Respondent Access
  • STAY CONNECTED
    • LinkedIn
    • Facebook
    • Instagram
    • X (Twitter)
  • PRIVACY
    • PRIVACY POLICY
    • TERMS & CONDITIONS
    • DO NOT SELL MY PERSONAL INFORMATION
    • PRIVACY REQUEST
    • ACCESSIBILITY

Copyright ©2025. All Rights Reserved BNP Media.

Design, CMS, Hosting & Web Development :: ePublishing