SIS is a full system for post-marketing Surveillance of Products. It provides features to improve quality and productivity in processes of Pharmacovigilance, Cosmetovigilance, and Toxicovigilance areas, covering the entire management process of adverse event reports and treatment, such as reception, analysis, submissions, and storage.

What does it offer?

• Compliance with the current legislation.
• Assists national and multinational companies of all sizes.
• Support to Pharmacovigilance (human and animal), Cosmetovigilance, and Toxicovigilance.
• Catalyzes cooperation of everyone involved in product safety processes.

Main features:

• Notifications and Alerts on important dates and deadlines.
• Receiving and managing of Reports.
• Makes integration possible with other corporate systems, such as SAC, CRM, and ERP.
• Issuance of standard reports such as CIOMS and full case report form, in addition to customizable reports, allowing to cross all data of the solution.
• Causality analysis employing Naranjo and Karch-Lasagna algorithms.
• Coding of cases using MedDRA, WHO-ART, in addition to ICD-10.
• Report export in XML for submission (E2B).

Organex offers full package of services to assure success in software implementation.

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