 Incorporated is among the world's best-known and most respected names in medical devices and supplies. Closely allied with top medical research facilities, teaching hospitals and leading specialists around the world, the COOK® Group supply innovative, physician-conceived, custom-crafted medical devices to health care providers.
Why a new labeling solution was needed
The efficient management and distribution of global products is a vital part of COOK®'s success. With the expansion of global trade and computerisation COOK® saw the need to replace plain language descriptions of products and services with identification systems that are usable in every trade and industry sector worldwide. It was decided to implement the European Article Numbering (EAN) bar code, a uniform and standard numbering system across the group.
This change brought the company’s labeling system under close scrutiny. It was very important that the labeling process was reliable, accurate and consistent across international sites. A flexible and robust labeling system that would automate the labeling process was needed. On top of this it was vital that the labeling system complied with the IVD Directive and FDA 21 CFR Part 11 regulations. Once installed the whole system would need to be validated.
COOK®, Ireland realised very quickly that they needed to upgrade their labeling system. The existing labeling system was a ‘homemade’ system linked to J Base, Cook Ireland’s ERP system. It was a text only system with a huge amount of manual inputs and limited format design flexibility. Their Quality Manager, Emmett Devereux contacted PRISYM ID, a labeling systems provider in the medical device, pharmaceutical and clinical trials sectors, with expertise in systems validation.
The Solution
Jason Putt, a PRISYM ID validated labeling expert worked closely with Emmett and his team to implement a new labeling system built around PRISYM ID’s PRISYM Medica labeling software. The PRISYM Medica software gives Cook flexibility to design their own label formats incorporating the new EAN barcode, which can then be locked for security.
Individual user permissions control what features and functions each user can access, for example employees in
despatch have a ‘print only’ user permission whilst Emmett has format design, format approval and print
permissions.
At print time no manual inputs are required, the user simply scans the works order then PRISYM Medica pulls down
batch/lot specific information from the ERP system and cross references to a secure product database to bring up
the correct label format automatically populating each label with variable batch/lot information.
A complete record of each activity is kept securely in PRISYM Medica with time and date stamping. Each record is
linked electronically to the electronic signature of individual users, in keeping with the FDA 21 CFR Part 11 rule.
PRISYM ID deliver more than great labeling software
PRISYM ID also assisted with the validation of the whole system and provided life cycle documentation for their
PRISYM Medica software.
Cook®, Ireland now has a truly compliant and future proof labeling system enabling them to confidently and
accurately label their products for worldwide distribution.
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Case Studies 
Mittwoch, 08. Februar 2012
