Serialization is not one-size-fits-all. With varying mandates across the U.S., EU, Asia, and the Middle East, companies must navigate a complex web of requirements. Are you prepared for global compliance?
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.
Comprehensive Compliance Documentation
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.
Real-Time Data Accessibility
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.
Audit Trail Capabilities
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.
Efficient Collaboration with Trading Partners
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.
Continuous Monitoring and Improvement
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.
100% Compliance Guaranteed
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.
PRG implements and supports a range of track-and-trace and supply chain compliance platforms including OneScan, the #1 DSCSA solution in the industry. Whether it’s a new implementation or a migration from an alternative solution, OneScan and PRG is your 100% compliance guarantee.
After doing multiple demos and attempting to use other vendor software (which I found unuseable), I’ll personally be using LSPedia's solution- they appear to me to be the only vendor with certain functionalities built as of the time of writing, such as connection to the Verification Routing Service (VRS) so that I can quickly conduct verifications of suspect product and clear it without the need for manual verification requests to pharmaceutical manufacturers.
Garrison Taylor
Director
TopRx
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.
Brad King
Business Operations
Kowa Pharmaceuticals
We consider LSPediA to be experts when it comes to the DSCSA and serialization. They know and understand the ever-changing regulations, and are proactive on putting things in place to get us ready to go live with serialization.
Ken Riester
VP Supply Chain
Kowa Pharmaceuticals
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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