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Compliance Regulation Gears

Committed to Compliance

As your trusted regulatory compliance partner, Legisym understands the importance of feeling confident that in the event of an inspection, you can quickly produce auditing reports and documentation to support your policies and procedures. With our service and solutions, our clients can be confident we are committed to both the highest level of compliance and service.

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Meeting All Mandatory & Optional Requirements for CSOS Set By the DEA

During the development phase of Express222™, our team spent countless hours architecting the system to ensure it was built to be fully compliant with Code of Federal Regulations (CFR) 21 parts 1305 and 1311. It is in this section of the CFR that the controlled substance ordering systems regulations are specifically mandated. To meet the audit requirements, Legisym contracted with the Drummond Group to certify the Express222™ CSOS application. Since receiving our initial Drummond Group certification in 2009, Express222™ has been audited, at our request and expense, four more times as we continue to roll out enhancements. While these audits are time consuming and expensive, Legisym is committed to providing our clients with the highest level of compliance and service.

COMPLIANCE TECHNOLOGY

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SIGNATURE VALIDATION
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AUTOMATED REPORTS
24/7 ACCESS
SECURE
DEA signature validation by Express222™ is automated and instantaneous. Notification of successfully signed and validated orders are sent immediately to both buyers and suppliers. Specific queries and automated reports designed to accommodate audit requests. These automated reports and queries will eliminate the burden and frustration of trying to find filed 222 forms or searching through spreadsheets of information. Express222™ provides suppliers and buyers with 24/7 access to their CSOS order, shipment, and receiving information. Express222™ is compatible with SHA-1 and SHA-2 security encryption.
Drummond Attestation Report

THIRD-PARTY AUDIT OF LICENSE VERIFY™

When we expanded our role as a partner in compliance with License Verify™, we were determined to help our clients feel confident in their license verification processes. For this reason, our service not only offers license verification through a user interface, providing all available data on demand with record-level and file-level audit trail reporting, we developed optional APIs to integrate data elements to a client’s internal systems and procedures, creating a fully automated process for verifying license data.

As part of our efforts towards supporting the industry and our partners, Legisym had the Drummond Group, the same independent software review and certification organization that has been trusted to audit Express222™ CSOS on five separate occasions, conduct a comprehensive review of License Verify™ in accordance with industry best practices and common application frameworks. During the assessment of the comprehensive, license tracking and verification service solution, Legisym’s 7 primary claims related to efficacy, accuracy, and usability were evaluated and findings officially documented. Claims such as:

  • accurately captures licensing data provided by regulatory authorities through electronic automation;
  • licensing data is refreshed as frequently as daily, (dependent upon the issuing authority) with no refresh longer than monthly; and
  • reduces the frustration of day-to-day tasks by integrating with internal systems.

To learn more about the Drummond Attestation Report of License Verify™ or to schedule a live demo, contact us today.

Legisym, LLC
Our goal at Legisym is to provide the Pharmaceutical Supply Chain with affordable and effective regulatory compliance services and solutions.
9325 Tarver Dr. STE C-101, Temple, TX 76502
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