Case Study
Integrating ERP & IQVIA SmartSolve eQMS for Life Sciences
Client
The client is a global medical device manufacturing company that creates breakthrough treatments for conditions affecting the head and the heart. As a heavily regulated company, they must comply with federal and global regulations and report product-related Complaints and Nonconformances (NCR).
Project Scope: IQVIA & ERP System
They are utilizing IQVIA SmartSolve as their Enterprise Quality Management System (eQMS) and want to make use of its NCR and Complaint functionalities.
These functionalities require utilizing patient and product data (including intermediary products, finalized products, product batch, and product line) stored in the client’s Enterprise Relationship System (ERP) system.
A little more about IQVIA SmartSolve eQMS for Life Sciences, from iqvia.com:
IQVIA’s SmartSolve® eQMS for life sciences is an award-winning platform that is built on four key pillars: Quality and Regulatory Compliance, Digital Content Management, Quality Management and Supplier Quality Management. Powered by Microsoft Azure, it leverages the latest in AI, analytics, and automation to enhance operational efficiency and ensure global compliance.
The Smartbridge Solution
The Smartbridge team assessed the customer’s needs, paying particular attention to data privacy and security best practices, and implemented a series of technical integrations between the client’s ERP System and SmartSolve.
Our solution focused on the following key aspects of the People, Process, and Technology framework:
Integrations with Enterprise Systems
Recognizing the value of consolidating relevant data in one system, we utilized a series of integrations to synchronize and make use of data from the client’s ERP systems.
We implemented an API look-up, allowing SmartSolve to query relevant patient and related product data, including product batch data, from the client’s ERP systems for use in Complaints and NCRs.
In addition, we developed an integration that pushes Product, Finished Product, and Product Line-related data to SmartSolve’s API endpoint. These integrations help us to ensure that users are only using pre-validated data as inputs, ensuring consistent, normalized data entry in reporting and helping to better maintain compliance with regulatory requirements.
Did you know? Salesforce Life Sciences Cloud uses IQVIA’s “ADA” engine for better predictive insights and guidance.
Salesforce has entered into a new partnership with IQVIA, licensing the latter’s Orchestrated Customer Engagement (OCE) platform to underpin and augment Salesforce Life Science’s Cloud offering.
Learn more >
Managing Data Privacy
Due to data privacy concerns, our custom API solution only enables look-up functionality for patient and related product for use in Complaints and NCRs, and is hosted on the client side, ensuring that Personally Identifiable Information (PII) remains secure.
Success Through a Modernized Implementation
The implementation of the integrated eQMS platform yielded significant benefits for the medical device manufacturer:
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