Where Knowledge Meets Innovation
A consumer reports a reaction through your branded form. SafetyOps records it as a case, reads the facts from their own words, and asks a person to decide what it is. It then tracks the four minimum elements FDA requires, counts 15 business days from the Day 0 your responsible person confirms, and holds the seriousness assessment, the electronic signature and the audit trail. Nothing is decided for you: every judgement names a person, and the record is kept for six years.
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