The number of U.S. Food and Drug Administration (FDA) inspections dropped dramatically in 2020, with the agency postponing most onsite visits to limit COVID-19 risks. The number of FDA warning [...]
Blog Home TAG: FDA Compliance Software
In Manufacturing Industries, Medical Device Industry, FDA Regulated Industries, Quality Management, Regulatory Compliance Management, Risk ManagementPosted
For decades, pharmaceutical and medical device companies have operated under the assumption that they must document and validate each and every software used in their processes. The concern was [...]
In Manufacturing Industries, FDA Regulated Industries, Quality Management, Regulatory Compliance ManagementPosted
Authors: Sal DiIorio, Principal Consultant, Semi-Tech Group Dave Vadas, VP of Special Projects, AssurX Quality management software by design is built to automate processes for specific [...]
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