Secure software used to print patient packaging labels

Citing the critical need for secure, compliant record keeping, Specials Clinical Manufacturing (SCM) of Prudhoe, U.K., which provides a range of manufacturing development and packing services for the clinical trials market, is adopting new software used for the printing of labels for patient packages.The system reportedly manages the printing of patient data, treatment codes, study centers, stratification group and patient visits while ensuring all data are kept secure and traceable for SCM.

The system selected is the Prisym Medica software with ClinTrial module from PRISYMID, Inc. (www.prisymidinc.com), which, the supplier adds, “offers powerful design features and specific functions for printing package labels.”

The software is said to provide a validated system that satisfies specific requirements of FDA and the U.K.'s Medicines Healthcare Regional Authority. For FDA, it complies with 21 CFR Part 11 regarding records and signatures.

It is also designed to provide a totally secure environment for label design, approval, automatic gathering of variable data and label printing. The software is also developed, tested and documented in accordance with strict GAMP (Good Automated Manufacturing Practice) guidelines and supplied with full life-cycle documentation based on the GAMP “V” model, the supplier notes.

The software reportedly uses high levels of security and data encryption to ensure systems integrity and regulator compliance, and is able to record critical activities, including time and date stamping, and electronically link them to individual users.

SCM packaging manager Elaine Mackie comments, “Initially, there was no suitable system in place for printing labels, especially labels for random studies and projects. We knew, however, what level of quality we required, and the PRISYMID system not only delivered, but also exceeded our expectations.”

In addition, she notes that the software “is user-friendly and has a very useful reminder mechanism.”

PRISYMID, Inc., 704/409-2351. www.prisymidinc.com