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Enhanced Compliance Cloud
Maintaining the integrity of the pharmaceutical supply chain is a group effort with all parties responsible for ensuring that they are conducting business exclusively with authorized trading partners and reporting to the relevant federal agencies on suspect or illegitimate product. Doing so without slowing the flow of product is what Enhanced Compliance Cloud enables.
Comprised of Powerful Modules
Solving from the ground up with best practice-based policies and procedures and an unrivalled platform for managing and monitoring license status of trading partners, Enhanced Compliance Cloud automates regulatory reporting enabling team members to spend less time on administration and more time growing your business.
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ATP Module
- License management, authentication and validation to ensure business exclusively with Authorized Trading Partners.
- Medpro and NABP integrations for real time license data.
- Secure record storage for audit and inspections.
SOM Module
- Monitor and track suspicious ordering activities of controlled substances.
- Automated alerting based on aggregated quantities and ordering behaviors.
- Visibility at the ingredient level to ensure compliance.
FDA 3911 Module
- Automatically generate FDA 3911 reporting of suspect product.
- Support compliance with 24 hour FDA-reporting requirements.
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Policies and SOPs
- Full set of policies and SOPs to adhere to federal and state regulatory requirements.
- Secure and accessible document storage with comprehensive version control.
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System Validation
- Complete compliance with FDA CFR 21 Part 11.
- Ensure secure and reliable connections between trading partners.
Traceability Cloud Benefits
Enhanced Transparency
Achieve unparalleled visibility into the entire supplychain. Real-time updates on product movements and status.
Operational Streamlining
Automated processes reduce manual efforts. Seamless collaboration with trading partners.
Actionable Insights
Access detailed analytics for informed decision-making. Customizable reports cater to specific business needs.
Global Compliance
Ensure compliance with country-specific serializationregulations. Mitigate risks associated with diverse global standards.
Make a Positive Impact on Your Business
The Global Traceability Cloud is a must have asset for pharmaceutical companies aiming to thrive in the dynamic and regulated global market.
Improved Efficiency
Streamlined operations lead to increased efficiency. Reduced risks of errors and delays in product movements.
Strategic Decision-Making
Access to real-time and historical data for strategicplanning. Proactive responses to supply chain dynamics.
Market Adaptability
Stay compliant with varying international regulations.Adapt quickly to changes in the global pharmaceutical landscape.
What's Included
- Turnkey DSCSA Compliance
- Seamless API Integrations
- Interoperable Electronic Data Exchange
- EPCIS 1.2, 1.3
- EPCIS Data Repository
- Reserve, Commission, and Aggregation
- Global Trading Partner Connection NetworkAS2, sFTP, and Portal
- Verification Router Service
- Lookup Directory (LD)
- Master Data Management
- Reporting and Analytics
- 1D & 2D Barcode Scan and Print
Complementary Clouds
Operations Cloud
Make and distribute serialized products with integrated Serialization Engine, Edge Warehouse solution, and real time product verification.
Learn MoreSupply Chain Cloud
Manage product movement beyond 4-walls. Resolve supply chain exceptions with Investigator, and gain customer and product insights with Big Data Analytics.
Learn MoreEnhanced Compliance Cloud
In addition to Traceability, adhere to other critical compliance requirement including cGMP, Part 11, SOM, ATP.
Learn MoreOneScan Suite Features
- Turnkey DSCSA Compliance
- Seamless API Integrations
- Interoperable Electronic Data Exchange
- Serialization & Product Identifier
- EPCIS 1.2, 1.3
- EPCIS Data Repository
- Reserve, Commission, and Aggregation
- Global Trading Partner Connection NetworkAS2, sFTP, and Portal
- Verification Router Service
- Lookup Directory (LD)
- Master Data Management
- Reporting and Analytics1D & 2D Barcode Scan and Print
- HQ Consolidation Reporting
- Business Intelligence & Data Analytics
- FDA 3911 Reporting (with auto-filled forms)
Seamless Operations
Solutions built for integration with workflow, automation, and data security at the core.
Highly Secure
All data is encrypted
Cloud-Based
Encrypted data is stored in our secured cloud
2D Scanning
Receive Pick Pack Ship Verify
Exceptions Manager
VRS EPCIS errors and discrepancies
Scalable
Single or multi-facility operations
FDA Validation
Single or multi-facility operations
Speak With a Solutions Expert Today
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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