FDA Compliance / Automation
Validation of Automated Systems for FDA Compliance
FDA regulatory compliance is a mission-critical requirement. If the FDA finds a manufacturer to be non-compliant to or in violation of FDA rules, the consequences can be severe with warning letters, mandatory product recalls, temporary shutdowns, criminal penalties and fines depending on the severity of the violation. These penalties imposed by FDA could seriously dent the manufacturer’s brand image and at times could even cripple the manufacturer financially. read...
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