Simplifi 797® for USP Chapter <800>: Hazardous Drug Compounding

USP Chapter 800 enforcement is approaching – are you prepared?

Simplifi 797 is a comprehensive web-based quality management system that helps meet the requirements of both USP Chapters <797> and <800> for compounding sterile preparations. It facilitates the ongoing compliance of training, procedures, and documentation essential to patient safety and risk mitigation.

Simplifi 797 offers turnkey compliance through policies & procedures, staff training and observational competency evaluations based on the expertise of trusted industry leaders at Clinical I.Q., led by Eric S. Kastango, MBA, RPh, FASHP.

“Simplifi 797 provides the tools and resources needed to ensure compliance with hazardous compounding standards mandated by USP Chapter <800>. The updated policies and procedures, competency assessments and facility-specific formulary are key to helping your cleanroom mitigate the risks from hazardous drug compounding.”

– Eric S. Kastango, MBA, BSPharm, FASHP

Using Simplifi 797 enables your compounding staff to manage USP 800 compliance:

  • Achieve compliance confidence. Streamline cleanroom operations and enhance compliance tracking documentation with on-demand compliance reporting capabilities to ensure trouble-free inspections.
  • Monitor and document activities on the go. Simplifi 797 has a mobile responsive interface for easy access – saving you time in your daily routine.
  • Receive expert guidance specifically customized for your facility. Access a customized quality assurance plan specific to your facility by the Clinical IQ team, led by Eric Kastango, MBA, RPh, FASHP – the leading expert in sterile compounding.
  • Educate staff and demonstrate training validation. Staff receive ACPE-approved, web-based sterile compounding training on hazardous drug compounding from Critical Point that includes policies and procedures specific to USP <800> that evolve as regulations evolve.

Additional Simplifi 797 features addressing USP <800> requirements enable staff to:

  • Implement expanded Hazardous Drug (HD) Policies & Procedures that meet proper hazardous drug compounding  requirements
  • Perform competency assessments on HD compounding with updated documents, including HD Decontamination, Cleaning and Disinfecting, HD Donning and Doffing, and HD Receiving
  • Manage a facility-specific formulary list of drugs classified as hazardous by NIOSH
  • Assign, collect and store Employee Hazardous Drug Risk Acknowledgement sign-offs and forms
 
Why Simplifi 797?

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