Software-as-a-Service model enables SME medical device manufacturers to achieve rapid compliance and end-to-end label lifecycle management
PRISYM ID today announces the general availability of PRISYM SaaS, its new cloud-based Software-as-a-Service offering. PRISYM SaaS is a compliance-ready platform for label lifecycle management, which makes available the core benefits of the PRISYM 360 enterprise class software solution to smaller and medium sized medical device manufacturers.
Chris Lentz, VP SaaS Business Development, PRISYM ID, comments: “PRISYM 360 was launched with the aim of transforming global label lifecycle management in the medical device industry through intelligent use of data, and was a focused direct response to the growing regulatory and compliance needs of organizations in the sector. With the FDA now increasingly clamping down on medical device companies to prove auditability and compliance with regulations such as UDI, there is a need for organizations of all sizes to take a strategic approach to the management of their data.”
The PRISYM SaaS offering takes a compliance-first approach and is hosted within a cloud environment exclusive to life sciences organizations. The underlying infrastructure is fully validated and is governed by strict quality assurance and regulatory compliance processes. Moreover, all PRISYM SaaS customer instances are formally qualified using a pre-approved IQ and the installed software is formally tested in the cloud environment. This means a minimum of customer specific validation is required to achieve full compliance.. This allows for rapid and cost-effective deployment in compliance with regulations such as FDA 21 CFR Part 11, removing most of the validation burden from the customer, enabling them to minimize manual record keeping and providing assurance in the event of regulatory audit.
Origen Biomedical, based in Austin, Texas, has adopted PRISYM SaaS for the management and production of labels for their range of medical devices. Jackie Jaskula, Director of QA and Regulatory at Origen Biomedical comments: “Smaller medical device manufacturers are coming under scrutiny. We need a Label Lifecycle Management system that can cost effectively capture, store and disseminate data safely, quickly and accurately that also helps us to meet validation and compliance challenges. The PRISYM SaaS compliance-first approach embraces these needs; allowing companies like ours to mitigate the risk of costly product recalls, expedite labeling and take control of label data across the organization.”
Key benefits of the PRISYM SaaS solution include:
- Compliance ready Label Lifecycle Management (LLM) platform providing data oriented management of complex labeling requirements;
- Easy to use label printing process enabling rapid deployment and reducing time to production;
- Centralized web based solution removes infrastructure management overhead;
- Automated version control and audit trail removes burden of manual record keeping;
- UDI readiness to support the FDA’s compliance requirements;
- Lifecycle documentation based on the GAMP 5 Model
Mick Daw, CEO at PRISYM ID concludes: “Many smaller manufacturers can neither afford a full enterprise class software solution, nor do they have the need for the wide range of functionality of the largest enterprises. PRISYM SaaS offers them the core functionality they require in a cost effective, ‘compliance-ready’ cloud platform, which will allow them to take control of label data across the business and demonstrate that they are addressing audit and compliance requirements.”