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FDA 3911 Module
Promptly respond to any illegitimate drug product investigations.
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Easily fill out DSCSA FDA form 3911 without errors
LSPedia's OneScan offers easy FDA 3911 reporting with auto-fill. With just the click of a button, OneScan will generate a complete 3911 form auto-populated with all of the correct data, ready to send, saving time and eliminating human errors from manual data entry.
DSCSA Mandates FDA 3911
The Drug Supply Chain Security Act (DSCSA) mandates the use of FDA form 3911, crucial for ensuring the traceability and accountability of prescription drugs. Form 3911, known as "Comprehensive Recall Request," is a tool used by pharmaceutical stakeholders to notify the FDA about drug recalls and product safety issues.
Requirement Submission for Recalls and Suspect Products
It's obligatory for the pharmaceutical supply chain to complete and submit form 3911 when a suspect product is identified or when recalling products due to safety concerns, quality issues, or regulatory violations. The form requires detailed information about the affected product, including its name, lot number, and reason(s). Additionally, companies must assess the potential risk posed by the product to public health.
Facilitates Communication
FDA form 3911 facilitates communication between the FDA and industry stakeholders throughout the suspect product investigation or recall process, aiding in evaluating the classification, scope, and coordination with other regulatory agencies. Compliance with 3911 form is essential for fulfilling regulatory obligations, ensuring the timely removal of unsafe products from the market, and maintaining the integrity of the pharmaceutical supply chain.
FDA 3911 Benefits
Reduced Administrative Overhead
Automated creation of Form 3911 so that employees can focus on adding human insights instead of redundant data entry.
Efficiency in Compliance
Reporting is a regulatory mandate, but that doesn't mean it has to be burdensome. Expert systems mitigate the effort and shrink reporting and response times to protect patients and integrity of operations.
Patient Safety
Ensuring the authenticity and integrity of product in the pharmaceutical supply chain is an industry-wide effort in which we all have a role to play.
Speak With a Solutions Expert Today
OneScan suite is the leading traceability solution, designed and proven to increase productivity, profitability, and supply chain visibility. LSPedia's seamless, cloud-based compliance solution streamlines the track and trace requirements with little impact on your daily processes.
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