The Life Sciences industry faces many challenges, such as constrained capacity and long production times, complicated distribution networks, as well as long product development lifecycles and the mandate to continually be innovating.
Inspirage has developed a number of innovative solutions leveraging both Oracle PLM Cloud and Agile PLM applications to address these challenges.
Ensure faster and safer time-to-value for new treatments and devices with streamlined product development and commercialization offerings.
Below are just a few examples:
1. Global Data Synchronization Network (GDSN)
The Medical Device industry is at a pivotal point in which regulatory bodies and customers require GS1-compliant data to be electronically transmitted to one another. As Medical Device companies dive head first into managing this mash-up of master data, manufacturers require a solution to meet not only the current requirements from the Food and Drug Administration (FDA) and the National Health Service (NHS), but also a solution that is scalable to support future requirements such as the EU’s Medical Device Regulation (MDR).
Inspirage’s GDSN (Global Data Synchronization Network) solution is an internet-based network of interoperable data pools and a global product registry, that enable companies to exchange standardized product data with trading partners, regulatory agencies, and more.
2. Global Product Registration
Struggling under the burden of keeping track of your product submissions in this ever-changing regulatory environment? Trying to enter international markets but manually screening each shipment to verify compliance?
Inspirage’s Global Product Registration process helps companies manage the regulatory process throughout your entire stage gate. The process starts with target market assessments during Concept, continues through management of the regulatory statuses across the various jurisdictions and electronic data submission and finishes with order and shipping compliance rules and validations. Our solution brings efficiency and order back to your processes while following a repeatable stage gate configured for your target markets. This solution is designed for global companies to manage across geographies, languages, and jurisdictions.
3. Unique Device Identifier (UDI)
Oracle has partnered with Inspirage to deliver a UDI Solution, enabling Medical Device customers to comply with the FDA UDI mandate. The solution is a holistic approach UDI implementation, spanning hardware as well as software, and ensures consistent, compliant labeling. Leveraging Oracle PLM, our 3-step solution performs the following functions:
1. Source & Cleanse: Find & validate legacy UDI attribute data for all SKUs;
2. Process & Manage: Attribute revision management & GTIN synchronization; and
3. Extract & Submit: FDA GUDID upload & integration to UDI (P.I.) system
4. Product Compliance
To directly address these challenges and many others, Inspirage offers a fine-tuned combination of Oracle products and custom Inspirage-built enhancements, ideal for improving forecasting and inventory planning. All key inventory data is viewable from a common platform, providing the visibility that is often missing from globe-spanning supply chains.
From product design through quality, risk and compliance, to product launch, we offer a centralized, coordinated approach to ensure product success.
Contact our team today to learn more about how we can help, and also be sure to check out our Resource Center for additional blog posts, webinars and other materials.
