That is why we have developed a new generation of cloud-based software to support a 360° view of the people, processes, and environment involved in the compounding process.
Process Analytical Technology (PAT) has been implemented for years, particularly by the chemical industry for the control of chemical processes. More recently, PAT has become a cornerstone of the US Food and Drug Administration’s (US FDA) Quality by Design (QbD) initiative for both the design and control of quality processes. We’re taking what industry has learned and applying it to Compounded Sterile Product preparation.
We understand that improving quality and efficiency while minimizing costs requires comprehensive, ongoing management. That’s why we’re combining the data elements you need into one convenient tool.
- Real-Time Engineering Controls – Help you document and critically evaluate key components of the production process to minimize the hazards and control worker exposure.
- Direct Process Inputs – Access personnel training records and facility, equipment, and service provider certifications to facilitate regulatory compliance.
- Integrated Measurements – Third-party interfacing to external systems allows documentation of batch validation reports and microbial and sterility testing.
- Continuous Data Collection – Incorporate sampling data directly into your production records, helping you identify trends that may require attention.
Plus, our web-based, Pharmacy-Focused ERP incorporates all the additional data collected with the InsightRX vision system, providing remote users an unparalleled view into the clean room.