Current Good Manufacturing Practice (cGMP) is a set of regulations that was initially put forth by the FDA to ensure that business organizations, manufacturers, and packagers of pharmaceutical products, medical devices, blood, and certain foods proactively guarantee...
It’s quite easy to mix up the Failure Mode and Effects Analysis (FMEA) from IEC 60812:2018 and the Hazard Traceability Matrix (HTM) in the ISO 14971:2019. Especially since nothing prevents a company from using these terms interchangeably or using different terms...
FDA 21 CFR Part 11 is a regulation that governs how Medical Device, Pharmaceutical, and other FDA-regulated companies should handle their electronic records and electronic signatures. The Life Science Industry is known for a vast number of regulations and various sets...
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