Ensure Quality and Compliance Standards Are Met in the Manufacturing Process

Painless Scaling for Batch with the Assure-Trak^® Compounding Management System

The Assure-Trak^® Compounding Management System

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

The Assure-Trak^® Compounding Management System

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

Batch Compounding

Our Batch Compounding module delivers everything necessary for the anticipatory compounding needs of health system and non-health system affiliated 503B Outsourcing Facilities in one convenient package.

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

Add Ons:

Assure-Trak^® Video Auditor

Passive Audit Monitoring

Assure-Trak^® Video Auditor 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 batch 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.

Assure-Trak^® Compounding EXchange

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).