Are You up to Date on USP <797> Guidelines?

Are You up to Date on USP Guidelines?

The revisions took effect in November 2023To help ensure you’ve got everything covered, we’ve created this guide to be your go-to resource for all USP Chapter <797> changes related to environmental monitoring. We cover a wide range of topics, including: Download your free USP <797> PDF now!

Leveraging Surface Sampling Performance Data to Strengthen Environmental Monitoring

Leveraging Surface Sampling Performance Data to Strengthen Environmental Monitoring

In pharmaceutical cleanrooms, viable surface sampling is one of the most practical ways to validate whether your contamination control strategy is actually working during real operations—not just on paper. But there’s a persistent problem: surface sampling is interpretive and trend-based, and its reliability depends on data quality and consistency. In highly controlled environments where true […]

It’s International Cleanroom Technology Week!

It’s International Cleanroom Technology Week!

We’re recognizing the importance of effective cleanroom cleaning in maintaining controlled environments, supporting compliance, and protecting product quality. At Berkshire Corporation, we’re proud to provide solutions that help teams clean with confidence. Learn More >

DEA Inspections and the 60-Day Audit Gap

It starts with a phone call. Someone from the lobby tells you the Drug Enforcement Administration is here — badge in hand, DEA Form 82 ready to sign. They are not asking for a tour. They are conducting a full accountability audit of your controlled substances. Read More >

What 340B Compliance Services Should Include

What 340B Compliance Services Should Include

340B compliance is not a one-time project. It is an ongoing responsibility that requires consistent documentation, clear workflows, staff education, and regular review. For covered entities, compliance services can help reduce risk and create a stronger foundation for program performance. The most effective 340B compliance services are practical. They help teams understand what is required, identify where gaps may […]

State Licensing for 503B Outsourcing Facilities

State Licensing for 503B Outsourcing Facilities

Health systems, med spas, and specialty clinics increasingly rely on 503B outsourcing facilities to stabilize supply, standardize quality, and alleviate in-house sterile compounding risk. But while FDA sets the federal framework, state-by-state licenses and permits determine whether a 503B can legally ship into your state—and those rules vary widely. This guide explains the federal baseline, […]

Why EHR Go-Lives Fail: The Labeling Risk Hospitals Overlook

Why EHR Go-Lives Fail: The Labeling Risk Hospitals Overlook

Electronic Health Record (EHR) transitions are meant to improve patient safety and streamline hospital workflows. But during go-live, one overlooked detail can introduce serious risk: labeling. When wristbands don’t print correctly, barcodes fail to scan, or specimen labels don’t match new workflows, critical safety protocols can break down. Medication verification slows, specimen tracking falters, and […]

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