Simplifi 797®

Simplifi 797 is a turnkey web-based quality management system that simplifies and automates ongoing compliance with essential USP Chapter 797 and USP Chapter 800 requirements for safety and risk mitigation—including comprehensive policies, procedures, staff training, competency evaluations, risk management, quality assurance practices necessary for a safe and efficient sterile compounding environment.

“Simplifi 797 equips pharmacies with all of the tools and resources needed to comply with the complexities of USP 797 and USP 800. It is the most comprehensive quality management solution available for enacting proper policies and procedures, elevating staff competencies, streamlining cleanroom operations and most importantly, protecting patients and staff from the risks of sterile and hazardous drug compounding.”

– Eric S. Kastango, MBA, BSPharm, FASHP

Using Simplifi 797 enables your compounding staff to:

  • Ensure staff and patient safety: With 24/7 monitoring and alerts to QA plan deviations, overdue task and other key notifications; expert consultations on facility-specific QA plans, policies and procedures, and continued best practice offerings.
  • Maximize operational efficiency: Simplify, streamline and automate cleanroom operations, enhance and automate compliance tracking documentation, and ensure trouble-free regulatory inspections – everything needed to maintain compliance with half the resources.
  • Standardize training and best practices: Web-based compounding training streamlines staff competency validation and offers easy access to CE Credit, while a comprehensive list of observational staff competencies helps validate proficiency and sterile cleanroom operations.
  • Scale for health systems: Best practices can easily be streamlined and standardized across multiple locations, while system-level risk, trends and deviations are more rapidly identified and communicated with on-demand reporting capabilities.

 

Insights

Take the first steps toward compliance with USP 797 standards

Accuracy of CSPs and ensuring a state of control are both needed in a cleanroom