The Boston Scientific medical devices manufacturer uses PRISYM MEDICA

PRISYM Medica enables manufacturing efficiencies and higher brand recognition for Boston Scientific

Boston Scientific, one of the world's largest medical device manufacturers, was looking to standardise on a single labelling system. Boston were running no less than 30 separate labelling systems. This project initially arose when a world wide branding exercise highlighted the huge variances in label formats and styles on secondary packaging. Closer investigation found that standardising on a single labelling system would offer not only consistent branding and format but other valuable business benefits such as increased efficiency and robust compliance measures.

The Challenge:

To deliver a collaborative environment across 20 plants and ISO production lines whilst providing centrally managed and secure controls over label formats and data. The specifications requested a label management solution with the following features:

• Central labelling system for design, approval and distribution of label formats
• Centralised control protected label data and templates, stored on a central server
• One process for PDM change request (CR) submissions
• 100% compliance with FDA 21 CFR Part 11
• Printing of label sets for multipacks
• Easier inclusion of barcodes and variable data
• Easy look up for label histories

The solution:

PRISYMID's specialist life sciences team worked with Boston to put together a detailed URS (user requirement specification). A solution was then developed based on PRISYM ID's flagship product PRISYM Medica.

PRISYMID implemented a network labelling solution that was integrated with Boston's SAP system and Windchill Boston's PDM. The new labelling system was also linked to the product database to improve variable data inclusion.

Because PRISYM Medica has been purpose designed for FDA regulated manufacturing environments very little customisation was required. This means the system is easily upgraded in the future and the project costs don't spiral as implementation progresses.

PRISYM Technology & Services

• PRISYM Medica labelling software
• Full lifecycle documentation
• Validation services including IQ, OQ and PQ testing
• Custom design to label production and also label design front ends

The benefits:

Marc White, Systems Project Manager for Boston Scientific has identified several benefits since installing the PRISYM Medica system;

• Corporate branding achieving higher recognition within clinics and hospitals
• Customers now familiar with where to look for information on labels as formats are standardised
• Disparate design shops replaced with a single smaller team as designs are managed centrally
• Variable data inclusion and barcodes automated eliminating labelling errors
• Quick and easy to add new production lines to the labelling system
• Easy to move product from one line to another to take advantage of tax, labour or shipping efficiencies

It was pretty obvious from the beginning that PRISYMID have a very strong grasp on software validation and the implications of FDA 21 CFR Part 11. PRISYMID has provided us with a labelling backbone integrated to our other enterprise systems and our product database.

Marc White, Systems Project Manager, Boston Scientific

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