Medical device manufacturer, OriGen Biomedical, has selected PRISYM ID’s label management solution to put data at the heart of its medical device labeling processes.
OriGen Biomedical is a growing, privately held medical device manufacturer founded and leading producer of cryopreservation, cell culture, and ECMO respiratory products with approx. 85 employees.
With the regulatory spotlight highlighting the need for a holistic view of labeling procedures, OriGen Biomedical recognized that taking a strategic approach to the management of their data would also enable them to increase their operational efficiency, improve time to market and reduce the risks associated with traditional, silo’d approaches.
With limited IT and Regulatory teams in-house, it was vital for the new solution to be easy to implement, comprehend, and use. The PRISYM SaaS offering was selected due to its compliance-first approach and it being hosted within a cloud environment exclusive to life sciences organizations, facilitating speedy implementation.
The underlying cloud infrastructure is fully validated and is governed by strict quality assurance and regulatory compliance processes. Moreover, the PRISYM SaaS application layer is also validated; meaning a minimal customer specific validation is required to achieve full compliance.
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Some benefits for OriGen Biomedical were:
- Automated approval workflow which removes most of the manual workload, speeds up the approval process and reduces the number of signatures required
- Reduced the overall cost of labeling and significantly reduced the labeling errors
- Dramatically reducing the need to amend circa 400 labels with the creation of just 4 templates
- Having a centralized web-based solution removes the infrastructure management overhead
- UDI and EU MDR readiness to support new and emerging compliance requirements
- Scalable solution which can be expanded as the business grows
- Cloud based solution enabling rapid deployment
- Compliance with FDA 21 CFR part 11 – Electronic signatures and approvals removing the need for manual sign off.
Richard Martin, CEO at OriGen Biomedical comments, “Smaller medical device manufacturers are coming under increasing scrutiny. We needed a Label Lifecycle Management system that could cost effectively capture, store and disseminate data safely, quickly and accurately that also helped 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.”
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.”
About OriGen Biomedical
OriGen Biomedical, Inc. is a leading producer of cryopreservation, cell culture, and ECMO respiratory products. OriGen’s focus is to produce a range of products to support the treatment of respiratory distress, cancer, genetic conditions, and other life-threatening diseases. The products are designed with the patient and user in mind and strive to maintain excellent customer service to ensure that patient care is the priority.
About PRISYM ID
World Class Label Management Software
PRISYM ID designs and delivers label management software for organizations that need complete product auto-identification and lifecycle traceability. With the continual tightening of labeling regulations and audits, PRISYM ID empowers its clients to safeguard their reputation by ensuring compliance, removing risk and significantly reduce costs by eliminating recalls through labeling errors.
PRISYM ID is the market leader in providing validatable world-class label lifecycle management and is trusted for delivering personalized service excellence to clients.