DSCSA Compliance for Manufacturers
LedgerDomain’s OCI-compliant XATP Digital Wallet powers secure credentialed DSCSA applications. Verify your trading partner’s Authorized Trading Parter (ATP) status, build a 6-year record of compliance activity, drive enhanced verification and interoperable tracing, and manage recalls and 3911s. The DSCSA Control Tower integrates with enterprise systems to manage and track compliance activity.
DSCSA Compliance Starts with Authorized Trading Partners
Verifiable Credentials are a digital “precheck” that prove that you’re an Authorized Trading Partner (ATP) under the DSCSA. These fully interoperable credentials comply with FDA guidances and industry standards including PDG, OCI, and NIST identity assurance. By securing your IT systems and preventing criminals from stealing your identity, Verifiable Credentials save you time on your journey to DSCSA compliance.
XATP by LedgerDomain Checks the Boxes for Manufacturers
Ensure that all your trading partners are Authorized Trading Partners (ATPs) under the DSCSA
Ensure that your establishment is registered with FDA
Systems and processes to respond to product tracing requests from ATPs and regulators
Systems and processes to respond to requests for product identifier verification from ATPs and regulators
Retain all records for at least 6 years
Your DSCSA Action Plan
ATP Credential + Address Book
Meet the “all-electronic” Authorized Trading Partner requirement.
Demonstrate your ATP status to direct trading partners
Check and log ATP status of indirect trading partners
Track your trading partners’ ATP status over time
Drive customer master data validation
Credential integrates with your VRS provider at no cost
Magic Portal for Trading Partners
Interoperate with stakeholders at all supply chain levels while reducing call center burden.
Email address validation
Instant onboarding for direct trading partners
ATP licensure checks for indirects
Automatic verification with Verification Router Service (VRS) integration
Trace requests
Exception reports (e.g. drop ship customers)
DSCSA Control Tower for Your Team
Executive web dashboard for all DSCSA compliance activity, including tracing and investigations
Manage tracing & verification requests
Manage exceptions reporting & resolution
Smart negative verification workflows
Track DSCSA compliance across a full range of activities
Access 6-year archive to support audits and investigations
5 Steps for Manufacturers
01 GET YOUR CREDENTIALS
Submit proof of being an ATP, and you’ll receive an activated credential in your wallet
02 FIRE UP THE CONTROL TOWER
Onboard your compliance team and start to monitor your compliance
03 BUILD ATP ADDRESS BOOK
Track and log the ATP status and supplementary data of your direct trading partners
04 ACTIVATE YOUR PORTAL
Provide a single channel for trading partners to submit DSCSA requests
05 MANAGE TRACING & 3911
Respond to tracing requests, recalls, log 3911s and more
…get your policies in order and you’re done!
Secure Your DSCSA Compliance Today
Manufacturer
$9000/year
- Wallet with ATP Credential
- Connection with VRS provider for inbound credential validation
- 2000 ATPs
- 10 users
- Export & archive
- PDG and OCI compliant
XATP Advanced
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- Additional named users
- Unlimited Address Book
- Unlimited trading partner identity confirmation and credential exchange
- Hosted DSCSA Magic Portal (trace, verification, exception reporting)
- Entity Resolution Tool for GLNs and addresses
- 6-year archive retention
- Email support
XATP Enterprise
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- Everything in XATP Advanced
- Unlimited credentialed identities (NIST Level 2)
- Unlimited trace request management
- Unlimited named users
- Enterprise-scale digital architecture (SSO, enterprise SLA)
- Partner modules (serialization EPCIS, T2/T3 management, VRS access, mobile scanning applications, advanced license verification)
- 3911 management, 12-year archiving & enterprise support
