A Revolution in Label Lifecycle Management - Take a 360° View of Your Label Production Process to Ensure FDA Compliance
In PRISYM 360, we have brought together all of 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 enterprise labeling 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 including FDA & EU regulations.
Today, product recalls caused by labeling and packaging defects, UDI compliance, label rework, just in time printing, local language requirements and automated label inspection (to name just a few) all have an impact on medical device production processes. So its easy to see why companies focus so much attention on labeling. However, a broader view of the procedure is essential. In the battle to deliver safe, accurate and compliant product information, it’s not just about the quality of the label – it’s also about the data.
With PRISYM 360, the costly mislabeling of medical devices is now avoidable. By providing a revolutionary 360° outlook of your organization’s master data assets and giving the ability to control and optimize them to create a fully integrated approach across the lifecycle, we can transform your production and labeling process.
Features & Benefits
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
- 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
- Lifecycle documentation based on the GAMP 5 Model to gain cGMP compliance by meeting all guidelines
- 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
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
As part of PRISYM 360 we have created six pre-configured and pre-validated print solutions. These standard out-of-the-box print front ends have been designed to provide a solution to common labeling and business process challenges whilst reducing cost and increasing speed of deployment.
PRISYM BluePrints include solutions for:
1. Sales Order/Goods Out Process
2. Purchase Order/Goods In Process
3. Product Printing Process: for small numbers of easily identifiable products
4. Approved Label Printing Process: for small numbers of labels across many products
5. Batch Manufacturing Process
6. Works Order Based Process
- [DATASHEET] PRISYM 360 506.59 KB
- [WEBINAR WATCH-BACK] A Revolution in Label Lifecycle Management - Taking a 360° View182.98 MB
- [WHITEPAPER] Implementing UDI (Unique Device Identification) 122.42 KB
- [WHITEPAPER] Aligning for Growth - The Evolution of Medical Device Labeling54.96 KB
- [INFOGRAPHIC] An Insight to Customers Top Labeling Challenges561.5 KB
- [INFOGRAPHIC] The FDAs UDI Initiative – A Definitive Guide804.14 KB