OneScan stands as the cornerstone for participants in the pharmaceutical industry, offering unparalleled support in achieving and responding to audit requests from federal and state regulators, as well as trading partners.
In a regulatory landscape where compliance is non-negotiable, and transparency is paramount, OneScan's robust features ensure a seamless and efficient process for audits.
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OneScan automates the generation and maintenance of comprehensive compliance documentation, ensuring that participants in the pharmaceutical industry are well-prepared for audits. The system meticulously captures and stores data related to serialization, traceability, and other regulatory requirements, providing a centralized repository for all necessary documentation.
In response to audit requests, OneScan offers real-time accessibility to critical data. Participants can swiftly retrieve relevant information, including product details, serialization records, and distribution history. This instantaneous access not only expedites audit responses but also demonstrates a commitment to transparency and compliance.
OneScan's audit trail capabilities are instrumental in demonstrating adherence to regulatory standards. The system records every interaction, modification, or transaction within the supply chain, creating an indisputable and verifiable trail of activities. This level of transparency is invaluable during audits, providing regulators and trading partners with confidence in the integrity of the pharmaceutical supply chain.
For seamless collaboration with trading partners, OneScan facilitates the sharing of necessary information in a secure and controlled manner. Whether responding to audit requests from federal and state regulators or trading partners, the system ensures that the right stakeholders have access to the right data, streamlining the audit response process.
OneScan's commitment to compliance goes beyond audit responses. The system continuously monitors and analyzes data, offering insights that enable participants to proactively address potential issues before audits occur. This proactive approach contributes to a culture of ongoing improvement and ensures sustained compliance in the ever-evolving pharmaceutical regulatory landscape.
In conclusion, OneScan emerges as an indispensable ally for participants in the pharmaceutical industry, facilitating seamless compliance and audit response processes. With its comprehensive documentation, real-time data accessibility, audit trail capabilities, efficient collaboration tools, and a commitment to continuous improvement, OneScan empowers pharmaceutical entities to navigate audits with confidence, ensuring regulatory adherence and fostering trust among regulators and trading partners alike.
OneScan suite is the leading DSCSA solution, designed and proven to increase productivity, profitability, and supply chain visibility. LSPedia's seamless, cloud-based compliance solution streamlines the track and trace requirements with little impact on your daily processes.
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OneScan suite is the industry's #1 turnkey, cloud-based DSCSA compliance and exceptions management solution suite for the entire pharmaceutical supply chain.
OneScan is the industry's leading platform for serialization and EPCIS data interoperability. EPCIS is where serialized events are created, updated, and stored. OneScan enables serial generation, encoding, commissioning, reworking, and decommissioning.
OneScan Connector 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 double data entry or human (data entry) errors!
OneScan is the industry's leading platform for serialization and EPCIS data interoperability. EPCIS is where serialized events are created, updated, and stored. OneScan enables serial generation, encoding, commissioning, reworking, and decommissioning.
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.
OneScan 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.
Access the OneScan ATP database of more than 31,000 authorized trading partners. Quickly find, add, verify, and manage your trading partners. DSCSA requires all of your trading partners to be authorized.
OneScan Investigator is the #1 cloud-based exceptions management solution for FDA's Enhanced Supply Chain Security requirement under the DSCSA. Investigator automatically identifies, alerts, and resolves EPCIS errors and discrepancies. There's no longer a need to hire additional staff to manage exceptions.
Management of expiring drugs has never been easier or more accurate. OneScan Expiry is a proactive platform with simple reporting and automatic notification of soon-to-expire products. Easy to use and fully automated to save you time and money.
Looking for superior customer service, best-in-class response times, and a white glove experience? You've come to the right place!
My experience with LSPedia has been exceptional, and the customer service has been fantastic. I am confident that LSPedia will continue to provide us with compliance to the regulations set forth by DSCSA.
LSPedia is so easy to work with, it’s been a home run. The testing went well, integration was fantastic. Working with the team has been easy, and they really know what they’re doing.
LSPedia's cost was in-line, it's user-friendly, but most of all it was the support and trust we have in LSPedia beyond almost anything. We have just had a really positive relationship for approximately seven years.
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