La serialización no es igual para todos. Con diferentes mandatos en EE. UU., la UE, Asia y Oriente Medio, las empresas deben navegar por una compleja red de requisitos. ¿Está preparado para el cumplimiento global?
La mejor solución para la trazabilidad en la cadena de suministro
OneScan es un sistema seguro basado en la nube que se integra a la perfección con cualquier software de planificación o gestión de recursos empresariales, permite una fácil incorporación de los datos de los Servicios electrónicos de información de códigos de productos (EPCIS) y se puede ampliar con módulos para una mayor funcionalidad y comodidad.
OneScan es un sistema seguro basado en la nube que se integra a la perfección con cualquier software de planificación o gestión de recursos empresariales, permite una fácil incorporación de los datos de los Servicios electrónicos de información de códigos de productos (EPCIS) y se puede ampliar con módulos para una mayor funcionalidad y comodidad.
La solución OneScan Pharmacy de LSpedia es la solución líder en la industria que cumple con la DSCSA para dispensadores. Con nuestra garantía de cumplimiento, puede dedicar su tiempo a lo que mejor sabe hacer: la atención al paciente.
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.
Nubes y paquetes
Standard Multi-Tenant
Además de la trazabilidad, cumpla con otros requisitos de cumplimiento críticos, como cGMP, Parte 11, SOM y 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.
Cree y distribuya productos serializados con el motor de serialización integrado, la solución Edge Warehouse y la verificación de productos en tiempo real.
Gestione el movimiento de productos más allá de las cuatro paredes. Resuelva las excepciones en la cadena de suministro con Investigator y obtenga información sobre los clientes y los productos con Big Data Analytics.OneScan Investigator, and gain customer and product insights with Big Data Analytics.
Un potente motor de datos que rastrea la incorporación de EPCIS, la cobertura de los productos de EPCIS, la calidad de los datos, las excepciones y el tiempo de proceso de envío.
El módulo Customer Portal brinda a los clientes intermedios acceso las 24 horas del día, los 7 días de la semana, los 365 días del año a sus datos de transacciones de ASN y EPCIS, lo que cumple con los requisitos de la DSCSA y fomenta la transparencia. Al ofrecer una plataforma centralizada y fácil de usar, el módulo mejora la eficiencia operativa al permitir a los clientes recuperar y descargar sus datos de forma independiente, lo que minimiza la necesidad de comunicación manual y permite que su personal se concentre en tareas de mayor valor. Este portal de autoservicio no solo garantiza el cumplimiento, sino que también promueve la interacción proactiva con los clientes y un flujo de trabajo empresarial simplificado.
El módulo de conformidad con la fiebre aftosa en la UE de LSpedia es un complemento de la suite OneScan. El módulo de conformidad con la fiebre aftosa de la UE, totalmente integrado en OneScan, es una poderosa herramienta diseñada para facilitar el cumplimiento del Sistema Europeo de Verificación de Medicamentos (EMVS) en virtud de la Directiva sobre medicamentos falsificados, según el Reglamento Delegado (UE) 2016/161 de la Comisión. Al automatizar la conversión y la carga de los datos de los lotes serializados en el centro europeo, el módulo de conformidad con la fiebre aftosa de la UE permite a los fabricantes comercializar en el mercado de la UE con facilidad y confianza, al tiempo que garantiza el cumplimiento de la normativa llave en mano.
El seguimiento y localización se refiere al proceso de seguimiento del movimiento de los medicamentos recetados desde el fabricante hasta el paciente. La Ley de seguridad de la cadena de suministro de medicamentos (DSCSA) exige que todos los medicamentos recetados se rastreen a lo largo de la cadena de suministro a nivel de unidades serializadas para ayudar a prevenir la distribución de productos falsificados, contaminados o dañinos por cualquier otro motivo.
La serialización EPCIS (Electronic Product Code Information Services) es el requisito de la DSCSA y el estándar GS1 para el seguimiento y la localización de los productos a lo largo de la cadena de suministro. Asigna un identificador único (número de serie) a cada artículo, lo que permite monitorear en tiempo real su ubicación y estado. Esto ayuda a mejorar la visibilidad de la cadena de suministro, mejorar la seguridad de los productos y garantizar el cumplimiento de las normas de la 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 es la solución líder de DSCSA, diseñada y comprobada para aumentar la productividad, la rentabilidad y la visibilidad de la cadena de suministro. La solución de cumplimiento fluida y basada en la nube de LSpedia agiliza los requisitos de seguimiento y localización con un impacto mínimo en sus procesos diarios.
Desbloquee la trazabilidad global y la seguridad de la cadena de suministro
Explore los desafíos y las estrategias para garantizar la seguridad de las cadenas de suministro farmacéuticas, alimentarias y de otro tipo. Descubra cómo las tecnologías innovadoras y los esfuerzos de colaboración pueden proteger la salud pública y mejorar la confianza de los consumidores en el mercado interconectado actual.
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