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Digitized Solution for Environmental Monitoring of FDA regulated cGMP Facilities - Tego
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Digitized Solution for Environmental Monitoring of FDA regulated cGMP Facilities

The FDA requires manufacturers operating under Current Good Manufacturing Practices (CGMP) to certify that every batch of drug, vaccine, or biologic be produced in a high quality controlled environment.

Digital Environmental Monitoring (EM) removes human factors and provides significant process improvement opportunities. These digital, data-driven solutions must survive sterilization. However, digital EM with sterilization-proof technology allows CGMP manufacturers to write data directly onto a) products and materials that must be tracked and verified before, during, and post-production and b) products and materials that monitor sterility. More importantly, digitized environmental monitorying makes data available via touchless, sightless procedures.

The digital traceability and visibility provides a full GMP compliance solution as well as an early warning system.

Tego’s environmental monitoring solution provides increased assurance of sterility for aseptically produced pharma and medical products.

Learn more about the solution here.

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