DSCSA Compliance Solution, CARO: The Next Chapter in Compliance‑as‑a‑Service for Pharmaceutical Regulatory Compliance, Credentials, and Master Data
- Spherity
- 2 days ago
- 7 min read
If your team has ever received a product identifier (PI) verification, tracing, or data request through VRS or email - without a DSCSA Authorized Trading Partner (ATP) credential attached - you’ve felt the operational friction first-hand. Do you respond? Is the entity legitimate? Has your VRS already auto-replied? What does that mean for future interactions?
Questions like that had sparked Spherity’s DSCSA compliance software, i.e. CARO’s, feature expansion. With CARO v1.3, we’re taking a decisive step from a VRS utility toward a comprehensive Authorized Trading Partner (ATP) master data and communication platform that is purpose-built for pharmaceutical regulatory compliance, verifiable credentials, and high‑integrity master data management.
And the bigger story isn’t just the features - it’s CARO’s long‑term vision as Compliance‑as‑a‑Service (CaaS) solution: like other Spherity products, CARO goes beyond software‑as‑a‑service. We’re building a compliance partner that automates governance, reduces risk, and turns efficient compliance management into tangible business benefits.
Why Spherity’s DSCSA Compliance Solution, CARO, is Expanding: Real‑World Challenges
Source pain point:
“When I receive a data request through VRS, tracing or other communication channels without DSCSA ATP credential attached, I want to be able to check their ATP status or, at the very least, their license status to decide whether to respond or, if my VRS has already responded automatically, to inform future interactions with this entity. I want a mechanism to feed this entity into my CARO address book, vet them and communicate securely.”
CARO v1.3 is designed to solve exactly this: provide point‑in‑time ATP verification and license checks, then give you the tools to add entities to your address book, vet credentials, and communicate securely - while building an auditable history for DSCSA and internal review.
What's New in CARO v1.3: Key Capabilities for Pharmaceutical Regulatory Compliance
Authorized Trading Partner Portal for Master Data Management
Direct & Indirect Trading Partner Management: Maintain master data for all your supply chain partners in a governed CARO Address Book.
Credential‑Backed ATP Status Check: Verify ATP status with confidence and alignment to PDG and OCI guidance.
Entity License Status Check: Validate license data against authoritative sources and monitor regulatory compliance continuously.
Hierarchical Structure: Organize credentials and licenses in parent-child relationships to map locations to the ATP’s headquarter.
Future Enhancements: Ongoing data monitoring and new integrations guided by customer requirements.
Invite Partners to CARO
Seamlessly invite direct and indirect trading partners to join CARO, making collaboration, credential exchange, and verification requests part of a consistent onboarding flow.
Message Portal for Connected Partners
Request Information: Send structured data requests and free‑text messages to partners for timely responses.
Document Exchange: Share and receive documents securely within CARO, with audit trails that support DSCSA.
Why this matters:
CARO v1.3 consolidates authorized trading partner data management, automated credential and license verification, and secure communications into one platform, so your pharmaceutical compliance workflows don’t have to live in separate systems. To deliver all this, CARO is powered by the regulatory compliance experts from Legisym. The outcome is improved master data quality, faster interactions, and reduced risk.
Beyond Software‑as‑a‑Service: CARO as Compliance‑as‑a‑Service
Compliance‑as‑a‑Service (CaaS) is the next era for regulated industries: managed governance, automated credential validation, continuous monitoring, and workflow orchestration delivered as a holistic service. CARO’s mission is to embody CaaS by combining:
Identity‑first master data and ATP status grounded in OCI verifiable credentials (VCs).
Continuous license monitoring (e.g. FDA, state boards, DEA) with event‑driven alerts.
Operational workflows (verification requests, corrections, merges, and status transitions) with full auditability.
Secure messaging and document exchange to keep compliance conversations inside a governed perimeter.
Scalable onboarding and collaboration, making compliance automation a shared capability across the network.
The result? Regulatory compliance becomes a repeatable, automated capability-not just a periodic checkmark. And when compliance becomes efficient, it creates business value: fewer interruptions, lower remediation costs, faster time‑to‑collaboration, and better data confidence across the pharmaceutical supply chain.
The Long‑Term Vision: Spherity’s DSCSA Compliance Solution, CARO, as Your Single Source of Truth
CARO is evolving into an identity‑driven DSCSA ATP master data platform that unifies partner records, preserves audit history, and drives integrity across domains.
1) Smart Deduplication Across Domains
Duplicate records across GLNs, contacts, licenses, and systems are a persistent source of errors. CARO addresses this at the entry point:
An ATP credential (a unique VC‑backed identifier) acts as a filter to ensure each entity is uniquely identified.
All records tie back to one ATP credential when available; for organizations without ATP credentials, unique enterprise IDs identify their CARO accounts.
Records without credentials or CARO accounts can still be maintained by users, and CARO will continue to streamline these processes based on feedback.
Once verified, duplicates are merged under the same ATP credential, with historical associations preserved for traceability and DSCSA audits.
Outcome: A single source of truth for each entity grounded in verifiable credentials and designed for regulatory compliance.
2) Hybrid, Near Real‑Time Updates
CARO, Spherity’s DSCSA compliance solution, blends real‑time credential verification with a disciplined schedule for license data refreshes:
Real‑time checks against issuer registries confirm credential authenticity and revocation status (e.g., OCI-compliant process).
License data is normalized and refreshed daily or weekly, depending on the source (e.g., FDA, state boards, DEA).
During ATP checks, the system cross‑checks cached license status, triggers immediate rechecks if data is stale, or requests manual verification when needed.
Outcome: A resilient hybrid model that balances responsiveness with high data integrity—ideal for pharmaceutical compliance workflows that never pause.
3) Transparent Handling of Unverified Trading Partner Data
Visibility matters even when data isn’t fully verified. CARO ingests unverified or partially verified records but segregates and labels them clearly.
Unverified ATPs are excluded from DSCSA compliance workflows (e.g., product verification requests) and automatically rechecked on a schedule or when new credential data arrives.
Outcome: Full partner visibility while maintaining compliance gating and data confidence.
4) Event‑Driven Notifications and Auditable Workflows
CARO, Spherity’s DSCSA compliance solution, provides proactive visibility across the lifecycle:
Verification Failures: Immediate alerts on failed credential or license checks.
Duplicate Merge Events: Notifications when multiple identifiers (GLNs, licenses, credentials) are consolidated.
Status Changes: Alerts when an ATP moves between states (Unverified → Verified, Revoked, etc.).
Audit Trail: Track verification attempts, merges, and status transitions for DSCSA compliance and internal audits.
Outcome: A transparent, auditable workflow with self‑service partner management tools, enabling faster resolution and stronger regulatory compliance posture.
Business Benefits: Turning Compliance Into Competitive Advantage
When compliance becomes automated, it becomes value‑generating:
Risk Reduction: ATP VC checks and continuous license monitoring lower the probability of interacting with non‑compliant entities and prevent downstream issues.
Operational Efficiency: One platform for credentials, master data, and secure messaging reduces swivel‑chair work and context switching.
Data Retention & Attestation: Just keeping files is no longer enough. Data create a searchable, electronic audit trail that proves during investigation that due diligence, like ATP check, has been completed.
Data Quality & Trust: Deduplication anchored to ATP credentials improves accuracy across systems—less rework, fewer disputes.
Audit Readiness: End‑to‑end audit trails and event logs compress audit cycles and reduce preparation overhead.
Faster Time‑to‑Collaboration: Structured requests and partner invitations accelerate onboarding of both direct and indirect trading partners.
Cost Savings: Automated checks reduce manual validation time, and early detection of licensing gaps prevents costly escalations.
Network Effects: As more partners adopt Spherity credentials and CARO workflows, identity assurance and pharmaceutical supply chain visibility improve for everyone.
Example Scenarios: How Our DSCSA Compliance Solution, CARO, Could Work in Practice
VRS PI Verification Request Without Credential
You receive a request via VRS without a DSCSA ATP credential.
You add the entity to your CARO Address Book with the little data you have.
You invite them to CARO and begin secure communications to resolve data gaps.
CARO performs a real‑time credential or license status checks.
Until verified, the entity is excluded from DSCSA workflows; CARO schedules automatic rechecks and logs all attempts for auditability.
Onboarding an Indirect Trading Partner
Invite the partner to CARO, prompting them to share ATP credentials or relevant license information.
CARO ties records to the credential (or enterprise ID), prevents duplicates, and builds a master data profile.
Use the Message Portal to exchange documents securely and request corrections where needed.
License Lapse or Revocation Event
CARO’s continuous monitoring detects a license issue and triggers an immediate alert.
The partner’s status updates in the ATP Credential Dashboard; the entity is temporarily gated from DSCSA workflows.
Your team initiates remediation via CARO, and the platform preserves the audit trail across status transitions.
Duplicate Consolidation Across Systems
Multiple GLNs or license IDs surface for the same partner.
CARO merges duplicates under the unique ATP credential, preserving historical associations for traceability.
A Duplicate Merge notification informs stakeholders; downstream systems receive clean, reconciled data.
Architecture & Governance Principles for Pharmaceutical Regulatory Compliance
Verifiable Credentials (VCs): CARO leverages OCI guidance for ATP credentials, enabling interoperable, tamper‑evident identity assurance aligned with pharmaceutical regulatory expectations.
Identity‑Driven Master Data: The ATP VC serves as the primary key, ensuring integrity across partner records and domains.
Event‑Driven Model: Real‑time checks, automated refreshes, and alerts keep regulatory compliance responsive.
Security & Privacy by Design: Secure messaging, scoped permissions, and auditable actions maintain confidentiality while enabling collaboration.
Customer‑Led Roadmap: CARO grows with your requirements—new registries, workflows, and integration points prioritized based on feedback.
The Journey from VRS Utility to Compliance‑as‑a‑Service
Seed Your Address Book
Import known partners and identifiers (GLN, license numbers, contacts) and let CARO evaluate credential and license coverage.
Define Roles & Policies
Configure access controls, verification workflows, and escalation paths for verification failures or license anomalies.
Invite Partners
Use CARO’s invitation flows to onboard direct and indirect partners, requesting ATP credentials or license documentation as needed.
Automate Checks & Notifications
Enable real‑time credential validation, scheduled license refreshes, and event‑driven alerts to keep stakeholders informed.
Measure What Matters
Track KPIs like verification cycle time, duplicate reduction, audit findings resolved, and partner onboarding speed. Translate efficient compliance management into measurable business outcomes.
Why Spherity’s DSCSA compliance solution, CARO, Why Now
The pharmaceutical ecosystem is moving decisively toward verifiable credentials, interoperable master data, and Compliance‑as‑a‑Service. CARO v1.3 is your near‑term foundation, and CARO’s roadmap is your long‑term partner:
Identity‑first governance that reduces duplication and error.
Continuous monitoring that turns reaction into prevention.
Secure, auditable communications where compliance decisions are made.
A compliance partner—not just software—aligning to Spherity’s vision of automating compliance in regulated industries.
Tell us which registries matter most, where your workflows get stuck, and how CARO can streamline your world. We’re building this with you.
Final Thought
Compliance isn’t just a checkbox. With CARO, pharmaceutical regulatory compliance, credentials, and master data management become a continuous capability-automated, auditable, and collaborative. As a Spherity platform, CARO goes beyond software‑as‑a‑service to deliver Compliance‑as‑a‑Service, helping you generate business benefits from efficient compliance management. That’s how pharmaceutical supply chains move forward-with confidence, integrity, and speed.
