Applied Clinical Trials

PRISYM Medica 5 software features RFID capability and ensures compliance with latest FDA regulations

Following the success of its powerful PRISYM 5 label software, PRISYMID has launched PRISYM Medica 5. PRISYM Medica label design and production software is specifically developed to meet the FDA's current requirements, in particular 21 CFR Part 11 rules regarding electronic records and signatures, and the Medicines Healthcare Regional Authority (MHRA). PRISYM Medica now offers additional state-of-the-art-features such as RFID support, mixed printer technology capability, multiple database linking and a special "Alert" system to monitor the printing process.

Suitable for the life sciences including pharmaceutical, medical device, clinical trial, biotech and fine chemical manufacturers, 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.

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. Plus, the system can be integrated with many other software packages, including ERP and MRP systems using the Datawatch module.

Developed with ongoing customer feedback, version 5 offers a number of additional benefits, including the management of RFID devices and printed labels. The software allows the user to take variable data from databases, ERP and MRP systems and design, print and write to RFID labels or to an RFID tag. Mixed technology capability drives thermal transfer, inkjet and industrial laser printers as well as managing all production coding, marking and labelling from a single platform.

A special "Alert" facility also allows users to monitor and control printers on a network from a central location. Reports and statistics on the printing process can be easily viewed to ensure efficiency and pick up error messages. The useful "label / message sets" function also enables printing of all labels and messages for a production batch, from a single print request, to any number of printers.

An additional module is also available for managing and labelling Clinical Trials. Trial resources managed by PRISYM ClinTrial include randomised patient lists, stratification of patients, study group or centre, patient visits, and treatment codes.

The PRISYMID team has over 20 years experience in delivering high quality labelling 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, the company is able to provide barcode, labelling, RFID and print solutions on a global scale. The company boasts a comprehensive range of software and consumables; from intuitive label design and print to automated track and trace systems.

For further information on PRISYMID Limited's products and services, please call tel: 0118 936 4400 or email Alternatively, visit (PID11)

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