Simplifi 797®

Simplifi 797 is a comprehensive web-based quality management system that helps to meet the requirements of USP Chapter 797 and recently published USP Chapter 800. It facilitates the ongoing compliance of training, procedures, and documentation essential to patient safety and risk mitigation.

Rely on expert-based guidance to ensure compliance with sterile and hazardous drug compounding standards to protect patients

Using Simplifi 797 enables your compounding staff to:

  • Identify and mitigate ongoing risks: Respond quickly to day-to-day deviations from quality assurance plans with real-time alerts on facility and system-level compliance risks.
  • Demonstrate compliance: Easily access reports on your compliance trends and issues for hassle-free inspections. Generate reports on trends and analysis by activity, compounding area or facility.
  • Receive expert guidance customized specifically to your facility: Receive a quality assurance plan developed by industry-expert Eric Kastango, RPh, MBA, FASHP to meet the unique needs of your facility. This plan includes a full set of policies and procedures that are regularly updated to meet the changing regulatory landscape of USP 797 and USP 800.
  • Educate staff members and demonstrate training validation: Staff members receive online ACPE-approved sterile compounding training with 33 hours of CE credit directly linked to USP 797 and 800 standards, as well as the opportunity to demonstrate training validation through observational competency documentation.

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