About 21 CFR Part 11

The pharmaceutical, biotech, and medical device industries have become dependent on computerized systems for every aspect of a drug’s lifecycle.  Clinical trials are managed using software; New Drug Applications are submitted to the FDA electronically; laboratory assays on a drug’s efficacy are performed using computerized instrumentation; and critical parameters in the drug’s manufacturing process such as temperature and pH are controlled using automated systems.  Labeling, adverse reaction reporting, consumer complaints, and pharmacy controls also depend on various computer systems working perfectly.  All these systems now fall under the jurisdiction of 21 CFR Part 11. Source: FDA Validation

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