GUIDANCE

Audit Support

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.

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GUIDANCE

Robust Features

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.

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Need more support?

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.

Learn about outsourcing with PRG