Tel: +44 (0) 118 936 4400 | Fax: +44 (0) 118 936 4499 | E-mail: info@prisymid.com | Web: www.prisymid.com©PRISYM ID Limited. All rights reserved. You may not copy, reproduce, transmit, store or modify any of the material in this brochure without prior written permission of PRISYM ID.

Tearing up the rule book We’re looking at labeling in a different way. With a high percentage of product recalls of medical devices caused by labeling and packaging defects, it’s easy to see why companies focus so much attention on the label as part of the production process. However a broader view is required. In the battle to deliver safe, accurate and compliant product information, it’s not about the label – it’s about the data.

The costly mislabeling of medical devices is avoidable. By providing a 360 degree outlook of an organization’s data assets and given the ability to control and optimize them to create a fully integrated approach across the lifecycle can transform the production and labeling process. It’s time to shift the focus.

The SolutionPRISYM ID has an unparalleled reputation for product excellence, innovation and delivery. In PRISYM 360, we have brought together all our industry knowledge, experience and client intelligence to create an elite core solution that is highly confi gurable to your company’s requirements and quick to deploy.

PRISYM 360 is a powerful, comprehensive, scalable and validatable solution which offers medical device manufacturers complete label integrity from data management to design and approval through to label production and inspection to meet the strictest compliance requirements.

PRISYM 360 adds value to your business in six main areas; driving positive change within your organization.

By implementing PRISYM 360, your organization will gain the following operational advantages:

• Provides a single scalable Label Lifecycle Management (LLM) platform across the enterprise that can mitigate the costly risk of product recalls due to labeling errors

• Supports 3rd party manufacturing, packaging, and labeling operations to assist with operational effi ciency objectives

• Offers UDI readiness to support the FDA’s upcoming compliance requirements

for Medical DeviceA revolution in label lifecycle management

Assisting with Consolidation

EnablingExpansion

ReducingRisks

Increasing Operational

E�ciency

OvercomingTechnical

Challenges

Achieving RegulatoryCompliance

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Tel: +44 (0) 118 936 4400 | Fax: +44 (0) 118 936 4499 | E-mail: info@prisymid.com | Web: www.prisymid.com©PRISYM ID Limited. All rights reserved. You may not copy, reproduce, transmit, store or modify any of the material in this brochure without prior written permission of PRISYM ID.

• Supports local language and country specifi c labeling operations across the globe

• Utilizes a global workfl ow for reviewing, approving, and version controlling label formats and data with high visibility and traceability

• Provides a platform to achieve global standardization of the labeling lifecycle including data, format, brand and operating procedures

• Implements a harmonized process to control the creation, editing and operational use of labeling content throughout the business

• Consolidates, controls and captures all instances of production label prints across manufacturing lines, distribution centers, as well as by 3rd party manufacturers

• Achieves signifi cantly greater fl exibility and control when managing production labeling of a specifi c product in multiple locations

• Leverages your existing network and IT assets, thus reducing capital outlay and protecting prior infrastructure investment

• Meets rapid deployment and validation specifi c requirements through low risk confi guration which accelerates operational effi ciencies and ROI

Core FeaturesThe PRISYM 360 platform delivers a large amount of functionality through a blend of pre-confi gured and confi gurable features that can resolve current and future global labeling challenges without requiring any custom development.

• Validatable solution capable of meeting FDA regulatory compliance, specifi cally 21 CFR Part 11

• True web-based solution that supports multiple browsers, offering a standardized solution to meet global labeling challenges

• Powerful document management including control of label images, IFUs, label designs and fonts

• Dynamic data management capability regardless of supporting database technology

• Desktop integration to Microsoft Word™ and Microsoft Excel™

• Secure version and revision control of all electronic records within the application

• Proactive workfl ow system to manage label related approvals

• Comprehensive label template designer featuring comprehensive coverage of barcode symbologies

• Flexible user permission model to support the diverse requirements of a global manufacturer

• Extensive support for rich text data content including color, font, size, sub-script and super-script

• Performs carbon-copy reprint, re-label or reconciliation of print jobs

• Supports customer specifi c printing processes using the powerful print front-end without requiring time consuming custom development

Our ExpertisePRISYM ID has specialist professionals to support your global Label Lifecycle Management.

• Proven track record of implementations with global organizations, delivering rapidly realized business benefi t and tangible return on investment

• Demonstrable history of software innovation providing leading edge solutions to clients regulated by the FDA and EU

• Skilled professional services team to aid with solution design, implementation, confi guration and training

• Skilled validation experts to work with quality teams to support the implementation of a compliant Label Lifecycle Management solution in accordance with corporate quality guidelines

• In-house development, test and support teams to provide a complete end-to-end solution from a single vendor

• Global 24/7 software support

• Accredited as a GS1 solution provider to ensure production of compliant barcodes

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