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PRISYM ID's Medica Greatly Simplifies FDA and MHRA Compliance

DUBLIN, March 23, 2010 /PRNewswire/ -- PRISYM ID Limited today announced the launch of a new product that allows life science companies to review, validate and record their product labels quickly and efficiently while allowing greater collaboration across the process. PRISYM Medica is a web-based solution designed for life science companies that need to design, validate and approve labelling on a variety of products, from medical devices to pharmaceuticals and into clinical trials. The announcement was made from the Validation Week Europe conference in Dublin where PRISYM ID is sponsoring.

"With 200,000 deaths a year in the US alone caused by preventable medical mistakes(1), such as inaccurate or unclear labelling, accuracy, accountability, and thus compliance, are vital for life sciences," said Dave Taylor, Product Manager of PRISYM ID. "With every step of a product's development needing approval from many different people, often in different locations, simply designing, validating and approving labelling on products can be a very time-consuming, inefficient process. Even when this process can be automated, the relevant software will typically need to be installed at each location, turning what could be a simple process into an essentially massive change management process."

PRISYM Medica is a web-based product that offers life science companies a single solution to meet their packaging and labelling requirements. PRISYM Medica has been designed to increase collaboration and lessen the expense and inefficiency of validation, by allowing all relevant parties access to the design, review and validation process online. There is no need to install the relevant software at each location and the web-based nature of the solution also means that it is simpler to involve people simultaneously at each step of the label production process, making collaboration much easier.

PRISYM Medica is a simple to use label design and management application which allows you to develop, review, validate and distribute labels aiding with compliance for the Food and Drug Administration (FDA) and the Medicines and Healthcare products Regulatory Agency (MHRA) regulations, among others. It enables unique serialised codes to be automatically applied in the format necessary to meet local legislative requirements. Where appropriate, live batch information, destination information and intelligent serial numbers needed for compliance with international regulations can be passed for printing automatically.

    PRISYM Medica benefits include:

    - Secure, automated and accurate labelling for globally
      distributed life science products
    - Web-based using Microsoft Internet Explorer, allowing quick
      deployment and easy use
    - Automated printing and reporting of identity codes to comply with
      national and international standards
    - A proactive review and approval work engine, increasing the
      accuracy of layout and data used on labels and reducing the likelihood
      of product recalls
    - Support in meeting with FDA, MHRA and other compliance
    - Template-based label development, minimising the changes needed
      for each separate design
    - Design labels for global use due to Unicode compliance
    - Produce over 35 types of barcodes GS1 DataBar, ITF14, EAN,
      DataMatrix, Code 39, Code 93 and QR codes

"When your product is as important as pharmaceuticals and medical devices, zero defect labelling is vital," said Dave Taylor, Product Manager of PRISYM ID. "A lack of accuracy and clarity in labelling contributes to 1 in 10 NHS patients suffering from mistakes in their treatment(2), while without accountability in labelling, piracy and counterfeiting, which cost the life sciences industry $38 billion a year, become harder to spot. With PRISYM Medica, we are aiming to make this accuracy and accountability as smooth, simple and straightforward as possible for life sciences companies. By allowing greater collaboration and easier access, accuracy is improved. Also the validation becomes a much faster, lower cost process, which allows vital products to be rolled out much sooner."

In addition, PRISYM ID has an experienced team to support you with your labelling training requirements and specialist labelling supplies.


PRISYM ID design and deliver high quality, industry compliant RFID, labelling and barcode solutions for companies in a wide range of sectors including life sciences, chemical, manufacturing and automotive. With over 20 years experience and product development, the company boasts a comprehensive range of software and consumables from intuitive label design and print to automated track and trace systems. Our elite client list includes Johnson & Johnson, Pfizer, Allergan and Glaxo Smith Kline.

Headquartered in the United Kingdom, PRISYMID has offices in the USA and Europe as well as a strategic network of partners to meet our customers' needs on a global scale.

(1) Hearst media corporation investigation

(2) NHS figures


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