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The Basics of FDA Medical Device Classes

Success in the medical device industry requires more than just creating a good product – you must meet regulatory standards for your device to make a difference. That’s why when designing, building, or selling medical devices, it’s important to know and understand the FDA’s classification of your...

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5 Key Trends Impacting the Pharmaceutical Industry

The pharmaceutical industry is constantly evolving with new medications, changing regulations and pressure to reduce pricing. What’s next for the industry? Experts have identified five key trends emerging in 2019 that will significantly influence the way pharmaceuticals are manufactured and...

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The Benefits of Environmental Monitoring

In highly-regulated industries like pharmaceuticals, medical devices, and food and beverage, transparency and accuracy are essential to success. Changing technologies, an evolving regulatory landscape, and increasing demands for consumer visibility make this process even more complicated. That’s...

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Thermal Mapping from A-Z

When it comes to producing and storing temperature-sensitive products, sometimes the long list of terms and information involved in mapping can get a little confusing. Below is a list of abbreviations and key terms to help make digesting your mapping report and validation easier.

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FDA Noncompliance: Form 483 and Warning Letters in Environmental Monitoring

Companies operating in highly regulated industries are no strangers to FDA regulations, audits, inspections and noncompliance. Regulations cover a wide range of topics, from product labeling to environmental conditions to manufacturing practices. Companies operating in the medical device,...

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USP <795> and <797> Revisions: What Compounders Should Know

The United States Pharmacopeial Convention, or USP, is a nonprofit science-driven organization that establishes standards for medicines. These standards are developed with independent experts and are primarily published in a compendium of General Chapters. While USP deals with quality and...

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Advancing Alzheimer’s Treatment: A Promise for the Future

Many people have a connection to Alzheimer’s in some way. After all, the memory disorder affects over 43 million people worldwide. For anyone who has witnessed the disease firsthand, the impact on quality of life can be devastating. It’s no wonder, then, that so many resources – funding and...

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How to Prepare for an Audit in Five Easy Steps

One of the biggest issues companies have is complying with and passing audits – whether planned or surprise. And, that goes double for companies in healthcare, pharmaceuticals, and even manufacturing where regulatory standards can be stringent. If you're not ready, this can make for a sticky...

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8 Reasons to Switch to Cloud-Based Environmental Monitoring

From manufacturing to vaccines, tracking environmental conditions is essential to protecting your assets and remaining compliant with various regulations. Traditionally, monitoring temperature, humidity, pressure and more have been accomplished using chart recorders and data loggers. These...

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The Case for Environmental Monitoring Across Multiple VFC Locations

Vaccinations are one of the most regulated products within the healthcare industry, as they require strict temperature control at all stages, especially when storing and handling. FDA regulations and CDC guidelines for vaccines are designed to ensure their safety, purity, potency, and...

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