1. 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 Solution
PRISYM 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 configurable 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
efficiency objectives
• Offers UDI readiness to support the FDA’s
upcoming compliance requirements
for Medical Device
A revolution in label lifecycle management
Assisting with
Consolidation
Enabling
Expansion
Reducing
Risks
Increasing
Operational
Efficiency
Overcoming
Technical
Challenges
Achieving
Regulatory
Compliance
DATA SHEET

2. 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 specific
labeling operations across the globe
• Utilizes a global workflow 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 significantly greater flexibility and
control when managing production labeling of a
specific 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 specific
requirements through low risk configuration which
accelerates operational efficiencies and ROI
Core Features
The PRISYM 360 platform delivers a large amount of
functionality through a blend of pre-configured and
configurable features that can resolve current and
future global labeling challenges without requiring
any custom development.
• Validatable solution capable of meeting FDA
regulatory compliance, specifically 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 workflow 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 specific printing processes
using the powerful print front-end without
requiring time consuming custom development
Our Expertise
PRISYM ID has specialist professionals to support
your global Label Lifecycle Management.
• Proven track record of implementations with
global organizations, delivering rapidly realized
business benefit 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, configuration
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
DATA SHEET