What You Should Know:
– Wolters Kluwer Health has launched its new Advanced Compounding module for Simplifi 797, providing a comprehensive, closed-loop solution to meet the rigorous 2023 USP Chapter 797 requirements.
– The module is designed for pharmacies performing complex, high-risk sterile compounding, offering essential tools for batch tracking, extended beyond-use dating, and stringent documentation. This upgrade ensures confidence with every inspection, cementing Simplifi 797’s ability to support the full spectrum of compounding needs, from immediate-use to Category 3.
Wolters Kluwer Simplifi 797 Unlocks Precision and Compliance for Advanced Pharmacy Compounding
Advanced compounding is widely recognized as one of the most technically challenging and regulatory-sensitive areas of pharmacy practice. With the recent update to USP Chapter 797—which introduced stricter requirements for documentation, competency verification, and environmental monitoring—the need for robust, specialized compliance tools has never been more acute.
Wolters Kluwer Health today addressed this critical market demand with the launch of its new Advanced Compounding module for Simplifi 797. The module provides pharmacies with a comprehensive, closed-loop system designed to meet 2023 USP Chapter 797 requirements, even for the most complex compounding needs.
“Advanced compounding is one of the most challenging areas of pharmacy practice, requiring precision, specialized knowledge, and a focus on compliance and quality outcomes,” said Rebecca (RJ) Johnson, Corporate Quality Assurance Manager at Revelation Pharma.
Closing the Loop on High-Risk Workflows
The new module is specifically built to serve pharmacies performing the highest-risk compounding. This includes facilities that are compounding medications with longer shelf life (extended beyond-use dates) and those that start with non-sterile ingredients (nonsterile-to-sterile formulations).
The core value proposition is the ability to centralize and standardize traditionally fragmented, paper-based processes:
- Batch Tracking and Beyond-Use Dating (BUD): The module allows pharmacies to accurately track newly required batch data and maintain compliance for complex formulations.
- Enhanced Documentation: Simplifi 797 now manages comprehensive documentation requirements, supporting auditing and inspection readiness.
- Education and Competency: The platform includes content and educational resources developed by Wolters Kluwer experts, providing policy, procedures, training materials, and observational competencies.
- Environmental Monitoring: The system provides the ability to record environmental monitoring results in line with strict USP guidelines, ensuring confidence with every inspection.
According to Annie Lambert, PharmD, BCSCP, Clinical Program Manager for Compliance Solutions at Wolters Kluwer Health, the module was explicitly built for this high-risk area to complement the compliance and safety features of their IV Workflow Management solution.
“Now, our Simplifi 797 solution enables the full scope of compounders—from immediate-use to Category 3—to meet USP standards,” Lambert added. By supporting the entire scope of compounding, Wolters Kluwer is positioning Simplifi 797 as the definitive solution for pharmaceutical quality assurance and patient safety.
