NetSuite Industries: Life Sciences
Streamlining Compliance in the
Life Sciences & Medical Devices Industry
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 inventory movement documentation and support quality control with accurate lot and serial number tracking. Get comprehensive audit data, strengthen traceability for recalls, and monitor post-market product distribution.
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.
Precise Labeling for Highly Regulated Industries
For companies operating in the life science and medical device industry, a mislabeled product is more than an operational error, it’s a compliance risk. Whether you’re managing ISO 13485 requirements, FDA UDI mandates, or DSCSA serialization obligations, accurate labeling is the difference between operational excellence and costly non-compliance.
In a space where every label must reflect the right lot number, serial number, and expiration date, manual processes leave life science and medical device companies exposed to errors that can lead to product recalls, suspended licenses, and regulatory fines of up to $500,000 per violation.
RF-SMART Cloud Printing eliminates manual processes entirely, using NetSuite data to generate labels at the exact point of activity. Whether you are receiving, manufacturing, or picking, Cloud Printing automatically populates a label with lot numbers, serial numbers, and expiration dates, eliminating the need to physically enter item data.
For companies with UDI or GS1 compliance requirements, RF-SMART supports all industry-standard barcode formats out of the box. The result is full label traceability from raw materials to finished goods, giving regulated companies the confidence that every label is accurate, every time.
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How RF-SMART Helped Amatheon
Gain Complete DSCSA Compliance
“When regulators and industry leaders tour our facility, they consistently identify
our operation as a benchmark for how pharmaceutical compliance and
warehouse efficiency should be executed.”
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Challenges
Amatheon faced a critical DSCSA compliance deadline requiring capabilities their existing systems couldn't support, while simultaneously struggling with unstandardized picking processes across 1,800 SKUs.
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Solution
Amatheon chose RF-SMART for NetSuite, working hand-in-hand with the
RF-SMART development team to build a solution that addressed both regulatory compliance and end-to-end operational efficiency.
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Results
With RF-SMART for NetSuite,
Amatheon experienced:
40% accelerated pick times60% reduced replenishment lag99% picking accuracy250,000 shipments annually Earned the Supply Chain Excellence Awars for innovation in pharmaceutical traceability and operational efficiency
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