NetSuite Industries: Life Sciences
Streamlining Compliance in the
Life Sciences & Medical Devices Industry
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Balancing Regulation and Efficiency
The life sciences and medical devices industries operate within highly regulated and complex supply chains. Navigating strict FDA, ISO, EU MDR, and other industry-specific regulations, companies in these sectors must ensure the timely delivery of essential healthcare products and biological materials. This includes medical devices, pharmaceuticals, biotechnology products, and research materials. However, manual practices can significantly hinder production and distribution. Implementing a solution that streamlines compliance workflows in NetSuite is essential for the efficient daily operations of companies in these sectors.
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Inefficient Paper-Based Regulation Practices
In industries responsible for manufacturing and distributing essential tools, technologies, and biological products for diagnosing, monitoring, treating, and preventing diseases, adhering to regulations from global regulatory bodies is non-negotiable. With the risk of product recalls and market bans, companies in these fields often rely on manual, time-consuming processes in attempts to maintain compliance.
Traditional practices such as handwritten inventory counts, hand-created labels, and physical shipping documents introduce potential points of failure in the compliance system. By automating inventory management across the entire process in NetSuite, companies in the life sciences and medical devices sectors can eliminate the risk of non-compliance.
Streamlining Regulatory Compliance
RF-SMART's Warehouse Management System for NetSuite offers a variety of inventory management solutions that can help automate these manual compliance and quality control processes without disrupting operations. Companies in the life sciences and medical devices sector can implement and configure automated solutions to meet their specific needs. Below are some of the most adopted functions that RF-SMART customers in these sectors use:
Inventory Reporting Tool
Automate documentation of inventory movements and support rigorous quality control through accurate tracking of lot and serial numbers. This tool provides comprehensive data for audits and inspections, strengthens traceability for recall procedures, and aids in post-market surveillance by offering detailed tracking of product distribution.
Labeling Solution
Address complex labeling and packaging regulations by automating the creation of compliant labels. RF-SMART ensures accurate labeling, simplifies audits by maintaining label history, and enhances traceability through the generation and tracking of unique identifiers. Built-in compliance features help companies navigate intricate labeling requirements with ease.
Image Capture
Add a visual dimension to compliance efforts by streamlining documentation with visual evidence by capturing images of products and processes. This provides valuable visual data for audits and inspections and enhances traceability by linking images to specific items or lots.
Signature Capture
Enable electronic capture and storage of recipient signatures, providing proof of delivery. This feature supports chain of custody requirements, enhances traceability, and provides valuable documentation for audits and potential dispute resolution.
Lot and Serial Tracking
Enable precise tracking of individual items or batches throughout the supply chain. This feature simplifies recall procedures by providing detailed histories of each product's movement and status.
Automated Shipping for Enhanced Traceability
RF-SMART Shipping for NetSuite offers several key functionalities that can help companies in these sectors maintain regulatory compliance by ensuring accurate documentation of crucial shipping details, without disrupting operations. Automated features include:
- Real-Time Tracking: Visibility into the shipping process - monitor the location and condition of products during transit.
- Expiration Date Management: Prevent shipping expired products, ensuring patient safety and adherence to FDA and EU MDR regulations. RF-SMART enables FEFO (First Expired, First Out) inventory management, automates alerts for approaching expiration dates, and maintains detailed records for audits and recalls.
- Address Validation: Support compliance with data protection regulations like GDPR and HIPAA by safeguarding patient information. Additionally, it provides audit trails of shipment destinations and helps maintain chain of custody.
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How RF-SMART Helped Argonaut Achieve Successful Compliance
“RF-SMART lets us keep that process flowing without errors. In contract manufacturing, our largest priority is the protection of our clients’ materials. We have zero margin for error, and RF-SMART ensures that we are error-free.”
- Ben Siedschlag, Supervisor of Manufactuing and Operation
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Challenges
Argonaut Manufacturing Services, a start-up biotech contract manufacturer, faced significant challenges in establishing their business. These included designing compliant business and system processes from scratch, finding a suitable ERP system, implementing a scalable inventory management solution, and meeting strict regulatory requirements like ISO 13485. The company needed to eliminate errors associated with paper-based environments and ensure real-time tracking of materials throughout the manufacturing process.
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Solution
To address these challenges, they implemented NetSuite as their ERP and RF-SMART for inventory management, which provided crucial features such as lot and expiration traceability, cycle counts, bin location and material identification, and barcode label generation. RF-SMART's out-of-the-box functionality met both inventory and regulatory management needs, and was integrated across receiving, manufacturing, and pick-pack-ship services.
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Results
By implementing RF-SMART’s inventory management solution, Argonaut was able to:
Implemented real-time tracking of material movement through NetSuite, ensuring compliance Maintained error-free processes in material handling and inventory management Protected clients’ materials, meeting the zero-margin-for-error requirement in contract manufacturing
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