La sérialisation n'est pas une solution universelle. Avec des mandats variés aux États-Unis, dans l'UE, en Asie et au Moyen-Orient, les entreprises doivent faire face à un réseau complexe d'exigences. Êtes-vous prêt pour la conformité mondiale ?
La meilleure solution pour la traçabilité de la chaîne d'approvisionnement
OneScan est un système sécurisé basé sur le cloud qui s'intègre parfaitement à tout logiciel de planification ou de gestion des ressources d'entreprise, facilite l'intégration des données EPCIS (Electronic Product Code Information Services) et peut être étendu avec des modules pour des fonctionnalités et une commodité supplémentaires.
OneScan est un système sécurisé basé sur le cloud qui s'intègre parfaitement à tout logiciel de planification ou de gestion des ressources d'entreprise, facilite l'intégration des données EPCIS (Electronic Product Code Information Services) et peut être étendu avec des modules pour des fonctionnalités et une commodité supplémentaires.
La solution OneScan Pharmacy de LSpedia est la principale solution de conformité DSCSA du secteur pour les distributeurs. Grâce à notre garantie de conformité, vous pouvez consacrer votre temps à ce que vous faites le mieux : les soins aux patients.
Features single-tenant architecture, geo-redundant backups, and cyber resilience. FedRAMP® Moderate Authorized and built on the foundation of the OneScan system.
Country-Level supply chain security that meets diverse international compliance requirements. FedRAMP Moderate Authorized and powered by OneScan.
Nuages et offres groupées
Standard Multi-Tenant
Outre la traçabilité, respectez d'autres exigences de conformité critiques, notamment cGMP, Part 11, SOM, ATP.
Enhanced-Tenant
A high-performance hosting model designed for customers with growing volumes and tighter processing windows. Designed for up to 100MM serials/year.
Single-Tenant
A dedicated hosting model designed for customers with advanced security, regulatory, or scale requirements. Engineered with no practical serial limitations -- capacity sizes to customer’s roadmap.
Créez et distribuez des produits sérialisés grâce au moteur de sérialisation intégré, à la solution Edge Warehouse et à la vérification des produits en temps réel.
Gérez le mouvement des produits au-delà de 4 murs. Résolvez les exceptions de la chaîne d'approvisionnement avec Investigator et obtenez des informations sur les clients et les produits grâce à Big Data Analytics.OneScan Investigator, and gain customer and product insights with Big Data Analytics.
Un puissant moteur de données qui suit l'intégration des EPCIS, la couverture des produits EPCIS, la qualité des données, les exceptions et le temps de traitement des expéditions.
Le module Customer Portal fournit aux clients en aval un accès 24 h/24, 7 j/7 et 365 j/7 à leurs données de transaction ASN et EPCIS, répondant ainsi aux exigences de la DSCSA et favorisant la transparence. En proposant une plate-forme centralisée et conviviale, le module améliore l'efficacité opérationnelle en permettant aux clients de récupérer et de télécharger leurs données de manière indépendante, en minimisant le besoin de communication manuelle et en permettant à votre personnel de se concentrer sur des tâches à plus forte valeur ajoutée. Ce portail en libre-service garantit non seulement la conformité, mais favorise également un engagement proactif des clients et un flux de travail rationalisé.
Le module de conformité européenne contre la fièvre aphteuse de LSPedia est un complément à la suite OneScan. Entièrement intégré à OneScan, le module de conformité de l'UE contre la fièvre aphteuse est un outil puissant conçu pour faciliter la conformité au système européen de vérification des médicaments (EMVS) en vertu de la directive sur les médicaments falsifiés du règlement délégué (UE) 2016/161 de la Commission. En automatisant la conversion et le téléchargement des données de lots sérialisées vers le hub européen, le module de conformité FMD de l'UE permet aux fabricants de commercialiser facilement et en toute confiance sur le marché de l'UE tout en garantissant une conformité réglementaire clé en main.
Le Track and Trace fait référence au processus de surveillance du transport des médicaments sur ordonnance du fabricant au patient. La loi sur la sécurité de la chaîne d'approvisionnement des médicaments (DSCSA) impose que tous les médicaments sur ordonnance soient tracés tout au long de la chaîne d'approvisionnement au niveau de l'unité sérialisée afin d'empêcher la distribution de produits contrefaits, contaminés ou autrement dangereux.
La sérialisation EPCIS (Electronic Product Code Information Services) est l'exigence de la DSCSA et la norme GS1 pour le suivi et la traçabilité des produits tout au long de la chaîne d'approvisionnement. Il attribue un identifiant unique (numéro de série) à chaque article, ce qui permet de surveiller en temps réel son emplacement et son état. Cela permet d'améliorer la visibilité de la chaîne d'approvisionnement, d'améliorer la sécurité des produits et de garantir la conformité aux réglementations DSCSA.
LSPedia’s API Integration module offers 24+ standard RESTful APIs for easy integration to your business systems. Connector enables master data, serialized product data, and order data to flow seamlessly in real-time or in batches between connected systems. No more scanning into multiple systems or risking human (data entry) errors!
Serialized Lifecycle Management (SLM) automates the tracking, recall, and reconciliation of pharmaceutical products down to the lot and serial number. It replaces manual processes like emails, spreadsheets, and phone trees with guided, automated workflows that gives organizations a compliant and complete evidence trail. The platform's integrated expiry and recall management modules further streamline pharmacy operations by proactively surfacing near-expiration products and delivering precise, location-specific recall notifications.
Digital Link transforms standard GS1 barcodes into secure digital gateways that connect manufacturers, distributors, and dispensers to trusted product information.
Serialized Rev-Cycle Management (SRM) is LSPedia’s financial reconciliation solution that ties every post-sale financial event to the exact product serial number. Each transaction is executed in the right amount, for the right party, under the right contract terms.
Global TraceabiliOneScan Edge enables Scan In (receive) and Scan Out (pick/pack/ship) of packages utilizing the 1D UPC barcode and the 2D data matrix barcode. It also enables aggregation for serialized packages.ty Cloud is designed to empower pharmaceutical companies with unparalleled global traceability capabilities.
LSPedia's Verification Router Service for EPCIS provides a secure and efficient way for companies to manage their product data in compliance with DSCSA regulations. By routing and verifying product information in real-time, our service helps companies ensure that their supply chain operations are always compliant, efficient, and secure.
LSPedia's Authorized Trading Partner (ATP) module is a comprehensive solution that empowers pharmaceutical companies to fully adhere to the requirements of the Drug Supply Chain Security Act (DSCSA). To ensure that businesses engage exclusively with authorized trading partners, this module offers a wide range of features dedicated to license management, authentication, and validation.
OneScan Investigator is the go-to exceptions management solution for the FDA’s Enhanced Supply Chain Security requirement, a 2023 mandate under the Drug Supply Chain Security Act (DSCSA). It manages the errors and failures that arise from new DSCSA transactions including EPCIS and VRS.
LSPedia's OneScan offers easy FDA 3911 reporting with auto-fill. With just the click of a button, OneScan will generate a complete 3911 form auto-populated with all of the correct data, ready to send, saving time and eliminating human errors from manual data entry.
Enhanced Suspect Order Monitoring (SOM) is a OneScan module built for manufacturers, distributors, and other regulated stakeholders in the pharmaceutical supply chain to identify and manage potentially suspicious orders for controlled substances.
LSPedia's Authorized Trading Partner (ATP) module is a comprehensive solution that empowers pharmaceutical companies to fully adhere to the requirements of the Drug Supply Chain Security Act (DSCSA). To ensure that businesses engage exclusively with authorized trading partners, this module offers a wide range of features dedicated to license management, authentication, and validation.
LSPedia's Big Data module simplifies trading partner identification and management to enhance supply chain visibility and support holistic decision making. Seamless integration of GS1 standardized company prefixes, Global Location Numbers (GLNs), and Global Trade Identification Numbers (GTIN) enabling data analytics and ensuring accurate KPI calculation.
LSPedia’s API Integration module offers 24+ standard RESTful APIs for easy integration to your business systems. Connector enables master data, serialized product data, and order data to flow seamlessly in real-time or in batches between connected systems. No more scanning into multiple systems or risking human (data entry) errors!
The Customer Portal module provides downstream customers with 24/7/365 access to their ASN and EPCIS transaction data, meeting DSCSA requirements and fostering transparency. By offering a centralized and user-friendly platform, the module enhances operational efficiency by enabling customers to independently retrieve and download their data, minimizing the need for manual communication and allowing your staff to focus on higher-value tasks. This self-service portal not only ensures compliance but also promotes proactive customer engagement and a streamlined business workflow.
Global TraceabiliOneScan Edge enables Scan In (receive) and Scan Out (pick/pack/ship) of packages utilizing the 1D UPC barcode and the 2D data matrix barcode. It also enables aggregation for serialized packages.ty Cloud is designed to empower pharmaceutical companies with unparalleled global traceability capabilities.
EPCIS (Electronic Product Code Information Services) serialization is the DSCSA requirement and GS1 standard for tracking and tracing products throughout the supply chain. It assigns a unique identifier (serial number) to each item, allowing for real-time monitoring of its location and status. This helps improve supply chain visibility, enhance product safety, and ensure compliance with DSCSA regulations.
LSPedia's EU FMD Compliance Module is a bolt-on to the OneScan Suite. Fully integrated to OneScan, The EU FMD Compliance Module is a powerful tool designed to facilitate compliance with the European Medicines Verification System (EMVS) under the Falsified Medicine Directive by Commission Delegated Regulation (EU) 2016/161. By automating the conversion and upload of serialized batch data to the European Hub, the EU FMD Compliance Module enables manufacturers to commercialize in the EU market with ease and confidence while ensuring turnkey regulatory adherence.
LSPedia's Rx expiration management revolutionizes pharmacy operations by providing the capability to effortlessly generate accurate reports of all prescription products nearing expiration within the next 30, 60, or 90 days. This invaluable feature empowers pharmacy staff to efficiently identify and manage expiring items, saving hours that would otherwise be spent manually inspecting every shelf. Now, the team can redirect their focus to revenue-generating activities, ensuring a more streamlined and profitable workflow.
OneScan Investigator is the go-to exceptions management solution for the FDA’s Enhanced Supply Chain Security requirement, a 2023 mandate under the Drug Supply Chain Security Act (DSCSA). It manages the errors and failures that arise from new DSCSA transactions including EPCIS and VRS.
LSPedia's Recall Management sets itself apart as the most advanced recall system, leveraging comprehensive data on products received at each location. This strategic approach ensures unparalleled accuracy in recall notifications, allowing users to receive pertinent information only for products they have received. By eliminating unnecessary notifications, our system optimizes efficiency, enabling users to stay in compliance and protect their operations without wasting valuable time on irrelevant recall alerts for products not present at each location.
Track and Trace refers to the process of monitoring the movement of prescription drugs from the manufacturer to the patient. The Drug Supply Chain Security Act (DSCSA) mandates that all prescription drugs must be traced through the supply chain at the serialized unit-level to help prevent the distribution of counterfeit, contaminated, or otherwise harmful products.
LSPedia's Verification Router Service for EPCIS provides a secure and efficient way for companies to manage their product data in compliance with DSCSA regulations. By routing and verifying product information in real-time, our service helps companies ensure that their supply chain operations are always compliant, efficient, and secure.
Enhanced Suspect Order Monitoring (SOM) is a OneScan module built for manufacturers, distributors, and other regulated stakeholders in the pharmaceutical supply chain to identify and manage potentially suspicious orders for controlled substances.
"Before OneScan, we were doing everything manually. We were receiving transaction tracing through PDFs and validating serialization, lot numbers, and expiration data ourselves. At one point we had essentially one person dedicated all day just to validating T3 PDFs. It was a cumbersome process and it left a lot of room for error.”
Jeremy Condomina
Purchasing Manager
Prime Pharma Solutions
"As clinical trials become more complex and globally distributed, compliance has to operate in real time. Partnering with LSPedia has allowed us to embed serialization and traceability directly into our workflows, giving our teams the confidence to execute high-stakes shipments without delay."
Salim Shaikh
Founder & CEO
Spring Bio Solution
The implementation process we did with LSPedia was really seamless. Our wholesale line of business was a new operation. We were standing it up from the ground up, so we really needed to rely on LSPedia’s expertise to stand up our new ERP software system and then integrate LSPedia into our process.
Peter Fleck
Vice President of Operations, Birdi Pharmacy / Designated Representative, Birdi Wholesale
Peter Fleck
LSPedia shows a constant committment to improvement; whether it's their support or their product...they're always leveling up. The support team provides consistently thorough follow-up and clear, articulate communication. the support we receive represents a meaningful step up in service and is genuinely appreciated.
Zac Sweeney
EPCIS Data Encoder
Capital Wholesale Drug
LSPedia didn’t just provide software; they ensured we were fully compliant. Anytime we had questions, the LSPedia team knew DSCSA inside and out and guided us step by step. That level of expertise made a huge difference during audits. Thanks to their expert team our audit was smooth and successful.
La suite OneScan est la principale solution DSCSA, conçue et éprouvée pour améliorer la productivité, la rentabilité et la visibilité de la chaîne d'approvisionnement. La solution de conformité fluide et basée sur le cloud de LSpedia rationalise les exigences de suivi et de traçabilité avec un impact minimal sur vos processus quotidiens.
Débloquez la traçabilité mondiale et la sécurité de la chaîne d'approvisionnement
Explorez les défis et les stratégies liés à la sécurisation des chaînes d'approvisionnement pharmaceutiques, alimentaires et autres. Découvrez comment les technologies innovantes et les efforts de collaboration peuvent protéger la santé publique et renforcer la confiance des consommateurs dans le marché interconnecté d'aujourd'hui.
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