SOURCE: Bilcare

October 01, 2007 13:08 ET

Bilcare Offers a Secure Solution for Clinical Manufacturing

New PRISYM Labeling Software Meets FDA Requirements and Saves Time

PHOENIXVILLE, PA--(Marketwire - October 1, 2007) - In its ongoing mission to provide its customers service and quality beyond compliance, Bilcare Global Clinical Supplies (http://www.BilcareGCS.com) has installed PRISYM Medica label design and production software. Bilcare can print labeling projects in-house, saving customers more than 3 weeks of production time on average when compared to outsourcing. "The installation of PRISYM label software is the latest step in our ongoing effort to continually improve the quality of service we offer our customers," said Bilcare America's President, Vincent Santa Maria. "The recent upgrading of our packaging rooms, the expansion of our storage facilities and the enhancement of our IVRS capabilities are all important milestones for Bilcare and our customers."

PRISYM Medica label design and production software is specifically developed to meet the FDA's current compliance requirements, in particular 21 CFR Part 11. The software uses high levels of security and data encryption to ensure systems integrity and regulatory compliance at all times. It is able to record critical activities and electronically links them to individual users, along with time and date stamping. This is the same software labeling program used by many large pharmaceutical companies. In accordance with Bilcare's User Requirement Specification, the software can print labels in up to 32 different languages as fixed text, as well as sequentially numbered and randomized labels. PRISYM's software solution provides additional label project management tools such as reporting capabilities and study specific packaging configuration set-up.

PRISYM Medica provides a totally secure environment for label design, approval, automatic gathering of variable data and label printing. It is developed, tested and documented in accordance with strict FDA and GAMP (Good Automated Manufacturing Practice) guidelines and supplied with full life cycle documentation. The PRISYMLS team has over 20-years experience in delivering high-quality labeling and auto-identification solutions to companies in a wide range of industries. With offices in the UK and USA as well as an extensive network of international partners worldwide PRISYM has a well established global presence. The global reach of PRISYMLS has positive implications for Bilcare which currently has distribution capability into 50 countries worldwide. Bilcare's locations in India and Wales will also begin using this software in the near future.

Bilcare-Add 1

Bilcare Global Clinical Supplies serves the Americas, Europe, and Asia with clinical trial materials support, services and complete project management. Our services for solid, semi-solid, liquid, DEA (CI-V) and biotech clinical trial materials (CTM) satisfy a broad range of requirements; from pre-formulation research and development, analytical services and clinical supplies pack-aging and labeling, to IVRS, controlled temperature (cold and frozen chain) CTM storage, distribution worldwide, and returns and destructions accountability. Our integrated approach provides you with seamless service throughout your entire project. We combine our industry experience and our total clinical supply chain service and delivery to provide smart, efficient and innovative solutions.

For more information about Bilcare Global Clinical Supplies, please visit our website at www.BilcareGCS.com.

Contact Information

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