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    Breaking News

    Dion Label now Part 11 and Annex 11 compliant printer

    Part 11 was established in 1997 by the Food and Drug Administration (FDA) to regulate security of electronic records.

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    03.20.17
    Dion Label Printing has announced it is now registered with the FDA and compliant with both FDA 21 CFR Part 11 and EU Annex 11.  Located in Westfield, MA, USA, Dion prints labels, shrink sleeves, pouches and specialty medical products for multiple industries. The company was featured in the July/August 2016 issue of Label & Narrow Web as the subject of a "Narrow Web Profile."

    Part 11 was established in 1997 by the Food and Drug Administration (FDA) to regulate security of electronic records. The law was established for pharmaceutical, medical, and similar FDA-regulated biotech companies. As a label printer for those industries, Dion Label Printing was required to complete the process to be a compliant printer and provide guaranteed secure printing.

    EU Annex 11 was established in 1992 through the European Union and details the steps needed to maintain Good Manufacturing Practices (GMP) in relation to electronic records and systems. GMP helps maintain control over items produced to confirm quality is maintained. The law ties directly into Part 11 as quality and compliance is especially necessary in pharmaceutical and medical companies.

    Dion Label Printing understands the importance of maintaining compliance as it is mandatory for some of our FDA-regulated customers. As a printer, Dion understands it is now our responsibility to maintain compliance with Part 11 and GMP to meet the needs of our customers as they grow into larger markets.

    Co-owner John Dion comments, "As the FDA ramps up enforcement under 21 CFR Part 11, our compliance (and also with EU Annex 11) will provide select customers greater confidence in computer software, system and records security at Dion Label as required under the rules. Although the process is initially time-consuming, maintenance of our status will have minimal effect on the cost of product manufactured accordingly."
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      Pulse Roll Label Products presents PureTone to Vietnam

      Pulse Roll Label Products presents PureTone to Vietnam

      A conference was attended by more than 120 delegates representing the Vietnamese label and packaging industry.
      04.24.18

    • North America

      InPrint’s Industrial Inkjet Conference to focus on creative applications

      The conference will offer attendees the opportunity to learn from industry leaders who are developing the latest technology.
      04.24.18

    • North America
      TMI introduces enhanced coefficient of friction tester

      TMI introduces enhanced coefficient of friction tester

      The new 32-76e coefficient of friction tester uses advanced digital force signaling and high-speed data acquisition.
      04.24.18


    • North America
      Sato America appoints Tim Cook president

      Sato America appoints Tim Cook president

      Cook assumes the execution responsibility and oversight of the North and Central America, Caribbean, and Mexico business.
      04.24.18

    • Asia | Flexo Supplies | Flexography | Ink and Coatings | Prepress Supplies
      Flint Group will showcase latest products at Labelexpo Southeast Asia

      Flint Group will showcase latest products at Labelexpo Southeast Asia

      Taking place from May 10-12 at Bitec, Bangkok, the event’s premise is a clear focus on label and packaging printing.
      04.24.18

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      Ritrama materials help olive oil label win Bronze Award

      Ritrama materials help olive oil label win Bronze Award

      The "Great Label Award" was possible thanks to a long and fruitful collaboration between Ritrama and Umbralabel.
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    • Europe | Flexo Presses | Flexography
      Primoreels acquires new Nilpeter FA flexo press

      Primoreels acquires new Nilpeter FA flexo press

      Primoreels’ new FA is a 9-color, 17’’ flexo press with a double diecutting unit.
      04.24.18

    • Europe | Flexo Presses | Flexography | Label Converting Equipment
      Codimag appoints DewaFlex to strengthen Benelux support

      Codimag appoints DewaFlex to strengthen Benelux support

      The company aims to expand its presence and make its Aniflo printing technology more accessible in the region.
      04.24.18

    • Digital Printing | Europe | Flexography
      EDNN installs first MPS EF SymJet hybrid press in the Netherlands

      EDNN installs first MPS EF SymJet hybrid press in the Netherlands

      The press combines the fully automated MPS EF flexo platform and an integrated Domino N610i digital UV inkjet label press.
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    • Flexo Supplies | Flexography | Ink and Coatings | North America | Prepress Supplies
      Flint Group prepares for expansive INFOFLEX display

      Flint Group prepares for expansive INFOFLEX display

      Flint Group experts will be on hand to discuss the latest developments in prepress to press-side solutions.
      04.24.18

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      EskoWorld 2018 to feature

      EskoWorld 2018 to feature 'Packaging Connected'

      The event will be held on June 5-7 at the Hyatt Regency Hill Country Resort and Spa, San Antonio, TX, USA.
      04.23.18

    • Digital Printers & Presses | Digital Printing
      Uteco Group and Kodak announce availability of Sapphire EVO digital press

      Uteco Group and Kodak announce availability of Sapphire EVO digital press

      The Sapphire EVO digital press addresses a full range of low and high-volume applications that produce up to 20m2 per year.
      04.23.18

    • Europe
      Herma unveils new coating plant in Germany

      Herma unveils new coating plant in Germany

      The expansion will extend Herma's production capacity for self-adhesive materials by 50%.
      04.23.18

    • Flexo Presses | Flexography

      Prestige-Pak installs PCMC’s Fusion C flexo press

      The addition of the versatile press helps to mark the Wisconsin company’s 50th anniversary.
      04.20.18

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      Schawk Manchester receives FlexoExpert certification

      The UK site is the fourth within the Schawk organization to receive the Flint Group certification.
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    Breaking News
    • Pulse Roll Label Products presents PureTone to Vietnam
    • InPrint’s Industrial Inkjet Conference to focus on creative applications
    • TMI introduces enhanced coefficient of friction tester
    • Sato America appoints Tim Cook president
    • Flint Group will showcase latest products at Labelexpo Southeast Asia
    View Breaking News >
    CURRENT ISSUE

    April 2018

    • Pouch Converting
    • Metallic Inks
    • A COMMON $ENSE APPROACH TO COATING APPLICATIONS
    • Print Management Systems
    • Narrow Web Profile: Pacific Barcode, Inc.
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