PRISYM ID's Medica Greatly Simplifies FDA and MHRA Compliance
By Prisym Id, PRNESunday, March 21, 2010
Web-Based Solution Allows Faster Rollout, Greater Collaboration and Increased Accuracy When Labelling Pharmaceuticals and Medical Devices
DUBLIN, March 23, 2010 - 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
For further information, please visit www.prisymid.com or to arrange a web-demonstration call +44(0)118-936-4400.; PR Contact: Ana Williams, Spark Communications, +44(0)207-436-0420, ana at sparkcomms.co.uk
Tags: Dublin, ireland, March 23, Prisym Id