PRISYM ID: PRISYM SaaS for Label Management

Software-as-a-Service model enables SME medical device manufacturers to achieve rapid compliance and end-to-end label lifecycle management

PRISYM ID’s PRISYM SaaS cloud-based Software-as-a-Service is a compliance-ready platform for label lifecycle management, which makes available the core benefits of the PRISYM 360 enterprise class software to smaller- and medium-sized medical device manufacturers.

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.

PRISYM SaaS takes a compliance-first approach and is hosted within a cloud environment exclusive to life sciences organizations. The underlying infrastructure is validated and is governed by strict quality assurance and regulatory compliance processes.

The PRISYM SaaS application layer is also validated, meaning 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.

Key benefits of the PRISYM SaaS 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.

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.