Case Studies

COOK Inc. Implements PRISYM Medica to Manage Global Labeling and Localized Requirements

The Situation

COOK 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.

The Challenge

The efficient management and distribution of global products is a vital part of COOK’s success. With the expansion of global trade and computerization 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) barcode, 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 could comply with the IVD Directive and FDA 21 CFR Part 11 regulations. Once installed the whole system would need to be validated.

COOK, Ireland realized very quickly that they needed to upgrade their labeling system. The existing labeling system was a ‘home grown’ 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.

The Solution

COOK’s 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.

PRISYM ID’s experts worked closely with Emmett and his team to implement a new labeling system built around the PRISYM Medica labeling software. The PRISYM Medica software gave 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 dispatch 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 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.

PRISYM Technology & Services

• PRISYM Medica
• Full Lifecycle Documentation
• Validation Services

Benefits

• Individual user permissions
• No manual input during print runs
• Electronic signature of individual users in keeping with FDA rules
• Interfaced with business systems including various databases and their MRP/ERP
• Label format incorporates the EAN Barcode which can be locked for security
• System Validation