December 16, 2025
USP 797 Compliance Made Simple with Automated Monitoring
The stakes have never been higher for sterile compounding pharmacies. With USP 797 standards in full effect and regulatory agencies conducting rigorous inspections, facilities face mounting pressure to demonstrate complete compliance—or risk serious consequences. If you’re responsible for maintaining sterile compounding operations, you know manual environmental monitoring is time-consuming and error-prone. The good news? Modern
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March 18, 2019
BIMO Inspection Readiness Checklist & Guide: FDA BioResearch Monitoring of Clinical Trials
Did you know that an FDA inspector typically schedules a bioresearch monitoring (BIMO) audit within five days of arrival? Would your clinical have BIMO inspection readiness in such a short time? Well, it should be: these inspections can occur at any time during a clinical trial, and there is no hard rule for how much notice they have to provide. If you are
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February 15, 2019
Smart Lab: How IoT Healthcare Devices Will Improve Medical Research Labs
The “Internet of Things” has been growing at a stunning rate. Some experts have estimated more than 20 billion devices will be connected by 2020. There are already more devices connected to the IoT than there are people on the planet. The sheer expansiveness of the IoT has meant no field has been left untouched. Healthcare is
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November 16, 2018
How a CO2 Monitor Can Ensure Your Lab is Safe and FDA Compliant
Having high levels of carbon dioxide (CO2) in your laboratory can be potentially life-threatening for your employees if the proper precautions aren’t taken. Monitoring CO2 levels in your lab is essential in ensuring the quality of your product while maintaining FDA compliance. Fortunately, CO2 monitors are designed to keep your technicians and products safe. If you aren’t sure what
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