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http://www.oracle.com/us/products/applications/siebel/047101.pdf
The Siebel Adverse Event and Complaint Management module from Oracle allows companies to create, assign, investigate, and monitor corrective and preventative actions (CAPA). Corrective actions can be generated from a complaint investigation. ORACLE DATA SHEET 3 or from any internal product issue findings.
https://docs.oracle.com/cd/E05553_01/books/LSSIA/LSSIAComplaintCapture2.html
7 rows · Adverse events and complaints management (AECM) is an important process in the …
https://support.oracle.com/knowledge/Siebel/550034_1.html
Oracle's Siebel Adverse Events and Complaints Management (AECM) module provides customers with the ability to generate MedWatch 3500A reports for submission to Food and Drug Administration (FDA). Recent FDA guidelines change the format of the report and also add new reporting elements.
https://support.oracle.com/knowledge/Siebel/550038_1.html
Electronic Medical Device Reporting is one of several key enhancements planned for Oracle's Siebel Adverse Events and Complaints Management module. Currently, submission of mandatory FDA reports is done manually via U.S. Postal service or other parcel carriers.
https://docs.oracle.com/cd/E26802_01/doc.111/e26803.pdf
Oracle Argus Safety is an adverse event reporting and management system with an E2B+ interface. It enables you to import the files in E2B+ format and you can evaluate the files in the Oracle Argus Safety staging area. The adverse event case is then either accepted in Oracle Argus Safety as a new ca se or the case is appended as a follow-up
https://www.oracle.com/technetwork/cn/industries/adverse-event-complaint-management-349940-zhs.pdf
Oracle 的 Siebel Life Sciences 是专为医疗、生物技术和制药公司 设计的世界一流的客户关系管理解决方案。全球主要组织都在使用 Oracle 不良事件与投诉管理功能实现标准化，以显著提高合规性、 产品质量和组织业绩。 提高流程质量和一致性
https://pharmaceuticalcommerce.com/information-technology/make-adverse-events-and-customer-complaints-part-of-a-holistic-quality-management-system/
Nov 09, 2009 · Using a dedicated quality system to manage complaint handling and adverse event reporting removes the barrier of having to extensively customize an ERP such as SAP or Oracle, as they are generally designed to work out-of-the-box with a …
https://docs.oracle.com/cd/E26802_01/doc.111/e26803/chapterone.htm
Siebel Adverse Event and Complaint Management system is specifically designed for medical, biotechnology, and pharmaceutical companies to improve regulatory compliance, product quality, and business performance.
http://www.oracle.com/us/products/applications/057206.pdf
Oracle automates adverse event and product complaint management processes from the moment of awareness through reporting, monitoring and resolution.
https://www.oracle.com/industries/life-sciences/argus-safety-case-management.html
CSL Behring Trusts Oracle Argus for Pharmacovigilance. Oracle Argus is the market-leading solution for processing, analyzing, and reporting adverse event cases originating in pre- and post-market drugs, biologics, vaccines, devices, and combination products.
https://docs.oracle.com/cd/E26802_01/doc.111/e26803/title.htm
Oracle America, Inc., 500 Oracle Parkway, Redwood City, CA 94065. This software or hardware is developed for general use in a variety of information management applications. It is not developed or intended for use in any inherently dangerous applications, including applications that …
https://docs.oracle.com/cd/E26802_01/doc.111/e26804/aecmargussafety.htm
To install the Device and Drug Adverse Event: Siebel AECM and Argus Safety. Download Oracle Device and Drug Adverse Event Data Integration Pack for Siebel Adverse Event Complaint Management and Argus Safety 11.1 from edelivery. Unzip aia-aecm_argus-pip.zip. Navigate to the Disk1 directory: aecm_argus-pip/Disk1.
https://docs.oracle.com/cd/E26802_01/doc.111/e26804.pdf
Refer to Oracle Device and Drug Adverse Event Data Integration Pack for Siebel Adverse Events and Complaints Management and Oracle Argus Safety Implementation Guide for details on configuring more than one in stance of a participating application. 3 Pre-built Integration Deployment
https://basicmedicalkey.com/product-quality-complaints-versus-adverse-event-reports/
Aug 21, 2016 · Chapter 16: Product Quality Complaints versus Adverse Event Reports. The United States Food and Drug Administration (FDA) places a significant amount of emphasis on the need for pharmaceutical companies to develop an effective approach to complaint management, including the establishment of well-written procedures.
https://www.oracle.com/technetwork/cn/testcontent/2-clinical-trial-management-and-adv-132510-zhs.pdf
Adverse Event and Complaint Management Maintains All Adverse Events and Complaints in a Single Repository • Call Center Triage • Consistent, auditable process supports regulatory requirements • Consistent process improves data quality • Escalation promotes data integrity and history • Assignment manager automatically routes to appropriate
https://www.oracle.com/partners/en/most-popular-resources/oracle-base-portfolio-list-5796156.xls
Order Management Integration Pack for Oracle Transportation Management, Oracle E-Business Suite and Siebel CRM Order to Cash Integration Pack for Siebel CRM and SAP ... Device and Drug Adverse Event Data Integration Pack for Siebel Adverse Events and Complaints Management and Oracle …
http://www.oracle.com/us/industries/life-sciences/045889.pdf
Oracle solution offers integrated complaint and adverse event capabilities, which provides the industry direct integration of adverse events reporting to clinical data management system. This creates a unique single source of truth for both adverse event submission and reporting. Oracle’s end-to-end solution
https://www.slideshare.net/BioPharmSystems/oracle-adverseeventreportingsystemaers
Dec 25, 2010 · With its• Single repository of global unparalleled integration with Oracle Clinical and Oracle Thesaurus adverse event and complaint Management System, Oracle AERS provides companies with a data• Powerful case management solution to help manage adverse events and reduce risk.
https://blogs.perficient.com/tag/adverse-event-reporting-2/page/2/
When evaluating Oracle Argus Safety for the reporting and management of adverse events or product complaints, one thing is clear to me; a company can save a tremendous amount of time by leveraging Argus’ innate functionality to assist in the tedious tasks around case entry.
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