Activity Description : Sterile compounding operations require extensive documentation, ranging from master formulation records (MFRs) and policies and procedures to staff training, competency assessments and regulatory compliance records. Managing these requirements through fragmented or manual systems can create challenges with version control, accessibility, standardization and regulatory readiness. This session explores how two organizations leveraged digital solutions to modernize key components of their sterile compounding quality systems. Presenters will demonstrate approaches to centralizing and managing MFRs and implementing a digital platform for competency, compliance, and quality oversight. Attendees will hear lessons learned related to system design, governance, change management, implementation barriers, and ongoing maintenance, while gaining practical strategies for evaluating and applying digital solutions within their own sterile compounding operations.
Handouts/Tools:
Describe challenges associated with managing master formulation records, staff competencies, and regulatory compliance documentation across sterile compounding operations.
Identify opportunities to use centralized digital solutions to improve MFR management, competency assessment, documentation control, and regulatory readiness.
Discuss practical strategies for implementing and maintaining digital quality management solutions, including governance, change management, and approaches to overcoming implementation barriers.
.jpg)
