Environmental monitoring refers to the process of collecting environmental data over time and monitoring for any changes that could be detrimental to the manufacturing or distribution of a product.

In many cases, individual consumers cannot verify the quality of products that can significantly affect their health and safety. Instead, they rely on manufacturers and distributors to follow a strict set of practices to consistently manufacture, store, and distribute high quality products.

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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...

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.

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,...

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...

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...