News Placeholder - PRISYM ID’s Medica Greatly Simplifies FDA and MHRA Compliance

PRISYM ID’s Medica Greatly Simplifies FDA and MHRA Compliance

PRISYM Medica is a web-based solution designed for life science companies that need to design, validate and approve labeling 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 mistakes1, such as inaccurate or unclear labeling, 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 labeling 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 labeling 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 labeling 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

 

Dave Taylor, Product Manager of PRISYM ID commented: “When your product is as important as pharmaceuticals and medical devices, zero defect labeling is vital. A lack of accuracy and clarity in labeling contributes to 1 in 10 NHS patients suffering from mistakes in their treatment 2, while without accountability in labeling, 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 labeling training requirements and specialist labeling supplies.