Cumplimiento automatizado de la DSCSA con el módulo 3911 de la FDA

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.

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La DSCSA exige a la FDA 3911

La Ley de Seguridad de la Cadena de Suministro de Medicamentos (DSCSA) exige el uso del formulario 3911 de la FDA, crucial para garantizar la trazabilidad y la responsabilidad de los medicamentos recetados. El formulario 3911, conocido como «solicitud integral de retirada del mercado», es una herramienta que utilizan las partes interesadas del sector farmacéutico para notificar a la FDA sobre las retiradas de medicamentos y los problemas de seguridad de los productos.

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.

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FDA 3911 Módulo

Easily fill out DSCSA FDA form 3911 without errors

Rellene el formulario para acceder a la hoja de datos

La DSCSA exige a la FDA 3911

Requirement Submission for Recalls and Suspect Products

Facilitates Communication

FDA 3911 Benefits

Reduced Administrative Overhead

Efficiency in Compliance

Patient Safety

Hable hoy mismo con un experto en soluciones

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FDA 3911 Módulo

Easily fill out DSCSA FDA form 3911 without errors

Rellene el formulario para acceder a la hoja de datos

La DSCSA exige a la FDA 3911

Requirement Submission for Recalls and Suspect Products

Facilitates Communication

FDA 3911 Benefits

Reduced Administrative Overhead

Efficiency in Compliance

Patient Safety

Hable hoy mismo con un experto en soluciones