Navigation Links
PRISYM ID's Medica Greatly Simplifies FDA and MHRA Compliance
Date:3/22/2010

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
      regulations
    - 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.

About PRISYM ID

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

SOURCE PRISYM ID

Back to top
'/>"/>
SOURCE PRISYM ID
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
2. You May Have a Thyroid Problem and Not Know It - Particularly If Youre Over 60, Says a New Harvard Medical School Report
3. Local Medicare Contractors Expand Hypertension Coverage for CardioDynamics BioZ(R) ICG Technology
4. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
5. Globus Medical Raises $110 Million in Series E Financing Round
6. Quark Pharmaceuticals Appoints New Chief Medical Officer
7. Medicare Contractor Establishes Reimbursement Coding Guidance for Monograms Trofile Assay
8. Boston University Biomedical Engineers Find Chink in Bacterias Armor
9. Rochester Medical Anti-Infection Foley Catheter Demonstrates Effectiveness in Randomized Trial
10. Rockwell Medical Technologies, Inc. Begins Patient Enrollment for its SFP Dose-Ranging Study
11. Flexible Medical Systems Raises $1.2M Seed Investment for Initial Human Trials
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/18/2017)... CAMBRIDGE, Mass. , Jan. 18, 2017  Tarix ... Drug Administration has granted a Rare Pediatric Disease (RPD) ... treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB), a rare ... for RDEB and treatment is limited to supportive care. ... supplements the Orphan Drug Designation previously granted by the ...
(Date:1/18/2017)... Jan. 18, 2017  Robust competition in the ... discounts on medicine prices, according to a new ... study is among the first to examine the share ... manufacturers, pharmacy benefit managers (PBMs), health plans and other ... study is the first to show what happens when ...
(Date:1/17/2017)... NEW YORK , Jan. 17, 2017 ... Summary GlobalData,s new report, "North America Insulin Delivery ... the North America Insulin Delivery market. The report provides ... and average prices (USD) within market segments - Insulin ... Accessories. The report also provides company shares and ...
Breaking Medicine Technology:
(Date:1/18/2017)... West Lebanon, NH (PRWEB) , ... January 18, ... ... announces the launch of the revolutionary Active Brake Technology (ABT), an innovative braking ... and stability. , Active Brake Technology addresses one of the biggest concerns of ...
(Date:1/17/2017)... ... January 17, 2017 , ... Gym Source, America’s leading ... new showroom at South Dixie Hwy in Miami, FL. , “We are elated to ... “The new innovative in-store concept is designed to give clients a seamless and motivating ...
(Date:1/17/2017)... ... January 17, 2017 , ... SunView Software’s Service Smart Technology ... of the Year. , Each year, Pink Elephant recognizes a new product ... to address a specific business problem or opportunity. The award highlights original innovations that ...
(Date:1/17/2017)... ... ... Mirror Mirror Beauty Boutique, Houston’s premiere CoolSculpting provider , is proud ... Rewards Program. Practice founder, Paul Vitenas, MD FACS, is delighted that Mirror Mirror Beauty ... by Zeltiq, CoolSculpting is approved by the Food and Drug Administration as a safe ...
(Date:1/17/2017)... ... January 17, 2017 , ... SensorInsight ®, an Internet ... in the U.S.A. to offer Internet of Things (IoT) solutions based on ... sensor deployments such as monitoring solutions used to detect potentially hazardous conditions in ...
Breaking Medicine News(10 mins):