PRISYM Launches Powerful New Labeling Software For Life Sciences
PRISYM Medica 5 software features RFID capability and ensures compliance with latest FDA regulations
Following the success of its powerful PRISYM 5 label software, PRISYM Inc. has launched PRISYM Medica 5. PRISYM Medica label design and production software is specifically developed to meet the FDA's current requirements, most notably 21 CFR Part 11 rules regarding electronic records and signatures. 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, PRISYM Medica 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 link them to individual users, including 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 is supplied with full life-cycle documentation based on the GAMP ‘V' Model. In addition, the system can be integrated with many other software packages, including ERP and MRP systems using the Datawatch module.
Developed with ongoing customer feedback, PRISYM Medica 5 offers a number of additional benefits, including the management of RFID devices and printed labels. The software allows users to take variable data from databases, ERP and MRP systems and design, print and write to RFID labels or RFID tag. Mixed technology capability drives thermal transfer, inkjet and industrial laser printers as well as managing all production coding, marking and labeling 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 capture 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.
PRISYM Medica also offers powerful design features and contains advanced tools specifically created to meet the requirements of the world's pharmaceutical and medical industries. Label templates can be designed to cover a wide range of differing layouts. For example, support for double-byte characters allows the printing of languages such as Chinese, Cyrillic or Arabic using Windows True-Type fonts.
An additional module is also available for managing and labeling clinical trials. Trial resources managed by the PRISYM ClinTrial module include randomized patient lists, stratification of patients, study group or center, patient visits, and treatment codes.
SOURCE: PRISYM