OVERVIEW SAP manages the complex manufacturing processes implemented by Global Life Sciences organizations, processes which generate data required for labeling medical devices and other Life Sciences products. If this data is not accurately reflected on labels and associated documentation costly product recalls and damage to a supplier’s reputation can result. PRISYM 360, PRISYM ID’s flagship label lifecycle management solution, integrates with the SAP application environment, enabling manufacturing and distribution processes to be adapted to ensure timely synchronization of label related data and accurate printing of labels.

1. World-Class Label
Management Software
UK TEL +44 (0) 118 936 4400 | US TEL +1 508-948-6100
www.prisymid.com | info@prisymid.com
COMPLIANT LABEL LIFECYCLE
MANAGEMENT FOR SAP APPLICATIONS
OVERVIEW
SAP manages the complex manufacturing processes
implemented by Global Life Sciences organizations,
processes which generate data required for labeling
medical devices and other Life Sciences products.
If this data is not accurately reflected on labels and
associated documentation costly product recalls and
damage to a supplier’s reputation can result.
PRISYM 360, PRISYM ID’s flagship label lifecycle
management solution, integrates with the SAP
application environment, enabling manufacturing and
distribution processes to be adapted to ensure timely
synchronization of label related data and accurate
printing of labels.
With automatic creation of a comprehensive and secure
audit trail for all entity and process changes and strictly
enforced role based user permissions, organizations can be
sure of on-going compliance with regulatory requirements.
PRISYM 360
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 complete label
integrity from data management to design and
approval through to label production and inspection
to meet the strictest compliance requirements.
Deployed enterprise wide for compliant label
production by some of the World’s largest medical
device and pharmaceutical producers, PRISYM 360
provides the dynamic environment necessary to
assimilate processing for products added through
new development or merger and acquisition activities.
PRISYM 360 Key Features:
• Compliance ready: Meets regulations such as FDA 21 CFR
Part 11, UDI and EU Annex 11
• Dynamic data and label content management
• Secure version and revision control of electronic records
• Work-flow management of approvals
• Comprehensive role base security

2. World-Class Label
Management Software
UK TEL +44 (0) 118 936 4400 | US TEL +1 508-948-6100
www.prisymid.com | info@prisymid.com
The Power of SAP Integration
Organizations invest heavily in SAP to establish
a core platform for management, monitoring and
control of critical production processes.
By enabling output from these processes to
be synchronized with the label management
repository PRISYM 360 integration with SAP
ensures that accurate data is automatically used
for labeling purposes. For example batch production
data associated with Work Order transactions can
be imported into the PRISYM 360 data repository
for appropriate label processing.
Unattended printing means that labels and
associated documents, such as IFUs (Instructions
for Use) can be printed by SAP, minimizing delays
in printing processes. Rules defined in PRISYM 360
can determine what action needs to be taken in the
event of errors and events such as print job failures
or change approvals are recorded in a secure audit
trail maintaining compliance at all times.
Where source data required for labeling is held
in SAP and other applications, PRISYM 360 also
allows aggregation of all the necessary information
into a central repository for labeling purposes.
Compliance is Key
By integrating the SAP environment with PRISYM 360,
organizations benefit from the built in compliance ready
capabilities delivered by the platform and gain access
to the extensive knowledge and experience PRISYM
ID Professional Services has in taking customers from
deployment of label lifecycle management through to
full 21 CFR Part 11 and EU Annex 11 validation. Able to
support initiatives for regulatory compliance such as FDA
UDI (Unique Device Identification), PRISYM 360 provides
the assurance needed in the event of regulatory audit.
PRISYM 360
SAP Integration Benefits
• Centralized label lifecycle management
in a single, compliance ready platform
• Manage label data from core SAP modules
including Life Sciences, Manufacturing and
Distribution
• Single point production of labels from within SAP
• Support for changing regulatory requirements
and organizational profiles
• Validation remains external to the business
application
SAP ERP
Industry Solutions
Work Order
and
production
processing
data
Data
SAPPO
P360SAPIntegration
Acknowledgement
User Access
Label Printing
Secure Audit Approval