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Life Sciences

Refresher: Which IT Systems Are Regulated

If your company makes drugs, medical devices, or biologics (vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins), it is regulated.

If your company is regulated, then every IT system you use to design, develop, conduct trials, manufacture, package, label, store, distribute, install, or service your products is also regulated and must comply with the regulations that govern the countries and regions in which your company operates. This includes both IT systems you host on your own premises, as well as those available in the cloud.

With this in mind, we’ll move on to the next post in this series on maintaining regulatory-compliant IT systems in the cloud. Between now and the next post, feel free to download the related guide by filling out the form below.

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Marin Richeson

Marin joined the life sciences industry in 2001. Over the course of her tenure, she has held roles in clinical finance, IT, quality assurance, and validation. The diversity of her experience provides her with a unique perspective on the interconnectedness of this complex, multi-faceted industry. Marin Richeson is a lead business consultant in Perficient's life sciences practice.

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