Sterile Compounding Quality Management System
Increased attention to USP 797 compliance in the wake of several major, well -publicized investigations of compounding facilities has elevated the stakes for pharmacists and pharmacies that compound sterile medications. Your training, documentation and quality assurance processes need to be top notch to reduce the risk of fines or incidence reports.
Rely on expert-based USP 797 guidance to ensure compliance and protect patients
Simplifi 797 is a quality management system that ensures your pharmacy maintains the training, procedures and documentation essential to patient safety and risk mitigation of sterile compounding. You can be assured knowing the system:
- Provides expert guidance customized to your facility: In addition to best practices and procedure documents, you receive a custom quality assurance plan developed specifically for your facility, all developed by industry expert Eric Kastango, RPh, MBA, FASHP, ensuring that you have the right plan in place for your particular environment.
- Offers quality education with unlimited review: Staff members receive access to 30 hours of comprehensive, ACPE-approved sterile compounding training for pharmacists and technicians, all directly linked to USP Chapter 797 standards. They can review any of the training at their convenience.
- Documents USP 797 best practices: Automated processes ensure a high and consistent level of performance and ease identification of compromised compounded sterile products. The fully integrated system includes compounding logs, facility-specific batch templates that adhere to your master formulary and custom bar-coded labels generated directly from documentation logs.
- Identifies ongoing risks: Embedded management reports flag facility and system-level compliance risks, while real- time alerts allow managers to quickly respond to day-to-day deviations from quality assurance plans.