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Assure-Trak - Compounding Management Health System
The Assure-Trak Compounding Management System ensures patient safety and compliance while driving efficiencies. For the first time, a single system can be deployed covering all compounding across an enterprise. Users can easily produce both sterile and non-sterile compounds through a single platform. The Assure-Trak® Compounding Management System is designed to fulfill the needs of a single hospital, an outpatient infusion center, and your central fill facility distributing within your network of affiliated hospitals.
Rather than require manual effort to scan all possible ingredients to build an NDC database, ConsortiEX provides a Formulary Management System (FMS). FMS is updated daily with new NDCs, their therapeutic equivalents, and required compounding information for each scanned ingredient. FMS ensures 100% ingredient verification, removing the implementation and maintenance burden for our customers.
The Assure-Trak® Compounding Management System
The Assure-Trak® Compounding Management System was designed to support the unique needs of the health system community and strikes the ideal balance of process and quality controls, creating a unified system designed from the pharmacy’s point of view.
Assure-Trak® Compounding Management System is a highly scalable Software as a Service application, making it easier than ever to keep up with the latest enhancements by automatically including software upgrades. In addition, our system is cloud-hosted, reducing the need for IT involvement during implementation and for ongoing maintenance. Assure-Trak® Compounding Management System seamlessly integrates our Dynamic Patient Specific Compounding and Batch Compounding modules.
Other features of the Assure-Trak® Compounding Management System include:
- Label Customization by the pharmacy with no IT involvement
- Pharmacist Verification of all compounds remote, real-time, and in-line
- Recall Management to prevent, and identify, the use of recalled NDC/LOT combinations
Our Dynamic Patient Specific Compounding module is incredibly flexible. We are able to leverage existing interfaces to reduce the implementation timeline. Improve your patient safety outcomes by implementing a Compounding Management System in just a few months, rather than years.
Other features of our Dynamic Patient Specific Compounding include:
- Global Production Methods to customize and assign to one or many dataset CSPs
- Reduces time and cost of waste with multi-dose container and returned compound management
- Electronic Compounding Record for 100% of doses
- Bedside scannable labels for Barcode Medication Administration documentation
- Off-the-shelf hardware reduces IT evaluation time, purchasing and maintenance costs
- Bi-directional integration with EHRs using HL7 message protocol (FHIR)
Our Batch Compounding module delivers everything necessary for the anticipatory compounding needs of hospitals, pharmacies, and 503B outsourcing facilities in one convenient package.
Traditional IV Workflow Management Systems were designed for one-at-a-time dose preparation – but we took a different approach. While there are similarities, high volume anticipatory batch compounding and mini-batch patient-specific compounding require different workflows. Additionally, all batch compounds created with our Batch Compounding module may be used as an ingredient for any other compound – patient-specific or batch.
Other features of our Batch Compounding module include:
- Efficiently prepare and schedule anticipated patient-specific doses to increase IV room capacity
- All settings maintained within pharmacy requiring zero IT footprint and no HL7 interface
- Electronic and version-controlled Master Formulations for Batch CSPs and Compounding Records for 100% of compounds
Passive Audit Monitoring
InsightRX moves beyond isolated snapshots at a fixed point in time, to continuous video capture for more comprehensive monitoring.
- Continuous monitoring assures a more complete view of your compounding processes, reducing the risk of a decoy syringe or bag being used for image capture.
- Confirm the aseptic preparation of each production task, which is appended to the electronic back record and searchable per Production Task.
- Time & date stamped compounding tasks ensure pharmacists can view a single moment of production, as well as the entirety of the task.
Order Management Module
The Assure-Trak® Compounding EXchange allows customers and affiliate organizations to access inventories of certified-quality products and effectively manage demand.
- Centralize all inbound orders for both the hub-and-spoke approaches of a health system affiliated central fill facility and the distribution models of a 503B outsourcing facility.
- Our application is fully integrated and compliant with the DEAs Controlled Substance Ordering System (CSOS).
Outsourcing facilities have a unique set of operating requirements and traditional ERP-based pharmaceutical management systems are not cutting it. The DQSA increased the regulation and compliance requirements of outsourcing facilities. We built a compounding management system designed to ensure our customer’s compliance with DQSA and incorporates both pharmacy-based compounding and pharmaceutical-based manufacturing into one product.
For health system and non-health system affiliated 503B outsourcing facilities, meeting the FDA mandated manufacturing and compliance guidance of the DQSA is top of mind. You want confidence in your vendor to understand the unique production workflows required of an outsourcing facility, and has successfully supported each customer through their FDA audit.
Other features of our Assure-Trak® Compounding Management System include:
- Label Customization including ASTM and ISMP standards
- Documentation of all materials required and used within each batch
- Recall Management to prevent, and identify, the use of recalled NDC/LOT combinations
Other features of our Assure-Trak® Compounding Management System include:
- Label Customization including ASTM and ISMP standards
- Documentation of all materials required and used within each batch
- Recall Management to prevent, and identify, the use of recalled NDC/LOT combinations
Other features of our Batch Compounding module include:
- Fully customizable production tasks, including secondary technician and pharmacist approvals
- Quarantine process, allowing only role-based authority to approve or reject all procedures or specifications impacting the identity, strength, quality, and purity of the drug product
- Electronic and version-controlled Master Formulations for Batch CSPs and Compounding Records for 100% of compounds including uploaded Sterility and Stability Reports
Other features of our Batch Compounding module include:
- Passed an independent 21 CFR 11 audit, ensuring electronic signature and record integrity
- Fully customizable production tasks, including secondary technician and pharmacist approvals
- Quarantine process, allowing only role-based authority to approve or reject all procedures or specifications impacting the identity, strength, quality, and purity of the drug product
- Electronic and version-controlled Master Formulations for Batch CSPs and Compounding Records for 100% of compounds including uploaded Sterility and Stability Reports
Passive Audit Monitoring
InsightRX moves beyond isolated snapshots at a fixed point in time, to continuous video capture for more comprehensive monitoring.
- Continuous monitoring assures a more complete view of your compounding processes, reducing the risk of a decoy syringe or bag being used for image capture.
- Confirm the aseptic preparation of each production task, which is appended to the electronic back record and searchable per Production Task.
- Time & date stamped compounding tasks ensure pharmacists can view a single moment of production, as well as the entirety of the task.
Order Management Module
The Assure-Trak® Compounding EXchange allows customers and affiliate organizations to access inventories of certified-quality products and effectively manage demand.
- Centralize all inbound orders for both the hub-and-spoke approaches of a health system affiliated central fill facility and the distribution models of a 503B outsourcing facility.
- Our application is fully integrated and compliant with the DEAs Controlled Substance Ordering System (CS