CARA for RIM
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The CARA Life Sciences Platform is made up of different module which make up full Regulatory Information Management.
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Generis Company Presentation for RIM
The document discusses Generis's Intelligent Content Services Platform and CARA software. It provides an overview of CARA's capabilities for regulatory information management, submissions management, and other regulatory and clinical processes. It highlights CARA's flexibility and ability to support multiple use cases across the product lifecycle from development through commercialization. Examples of large life sciences companies using CARA for regulatory information management and submissions are also provided.
Controlling
Controlling is one of the most important management processes and involves determining if objectives have been achieved and if the objectives were appropriate. An effective control system links activities to organizational objectives and focuses on positive performance rather than blame. It also ensures employees understand expectations. Regular audits and feedback help evaluate performance and ensure improvements. Maintaining accurate records management manuals that describe policies, responsibilities, and procedures is crucial for effective control of records systems. The manuals should be tailored to an organization's needs and activities.
Importance of nursing informatics in health care delivery
Nursing informatics is the integration of nursing, information management, and information technology to support health care. In the Philippines, nursing informatics education and electronic health records can help improve documentation, communication, and patient outcomes. However, most Philippine hospitals still rely on paper records and have yet to fully adopt electronic systems. Developing nursing informatics and electronic health records according to local needs could help address issues like high nurse-patient ratios and promote safer, higher quality care.
Meter Data Management 2.0
The fact that a Meter Data Management (MDM) system is the single, secure repository for the millions of data points collected by an AMI makes it the logical solution for data analytics such as validation, editing and estimation that improve the accuracy of billing information. Yet, as a single-source system of record, the MDM also is the starting point for integration of meter-read data with other enterprise systems to improve real-time efficiency of network operations and business processes.
The MDM with meter modelling components and standardized connectivity can integrate with the utility geodatabase (GIS) and outage management system (OMS) to significantly streamline outage detection and restoration verification.
MDM integrated with the utility supervisory control and data acquisition (SCADA) system or distribution management system (DMS) allows comparison of information at substation/net-stations with aggregated meter data to detect potential theft or network loss during distribution. Similar aggregate comparison helps analyse power quality, identify demand trending and forecast demand. These network analysis capabilities empower accurate asset planning and the utility’s ability to meet demand without adding more capacity.
In all of these enterprise-level functions, MDM integration with the GIS provides valuable visualization that facilitates operator and analyst identification of areas of concern or opportunity.
The real-time network intelligence possible with such a powerful MDM solution can return substantial benefits to several utility operations and business processes — well beyond the initial-level billing accuracy improvement.
NURSING INFORMATICS.pptx
This document discusses nursing informatics topics including nursing records and reports, management information systems, electronic health records, telemedicine, and telenursing. It provides definitions and discusses the importance, types, and best practices for nursing records and reports. Records and reports are important for documenting care, communication between providers, and evaluating services. The document also defines management information systems and describes their objectives and importance for supporting strategic goals, planning, and evaluating health programs.
Modul diktat kuliah sia
Sistem informasi akuntansi merupakan strategi dan alat yang mampu mengendalikan transaksi perusahaan dan asetnya, mencakup data keuangan dan nonkeuangan untuk memperoleh informasi ekonomis yang akurat. Tujuan mempelajari sistem informasi akuntansi antara lain untuk menyediakan informasi yang relevan, akurat dan tepat waktu dalam pengambilan keputusan bisnis.
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This document outlines the process for conducting a records and information inventory. It describes identifying the purpose and scope of the inventory, gathering key information about records like their source, format, location, and users. The process involves identifying departments, prioritizing the inventory, reviewing work processes and repositories, interviewing staff, and creating a log of all repositories and a final organization-wide inventory. The goal is to understand an organization's information environment and identify issues to improve records and information management.
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The document discusses Generis's Intelligent Content Services Platform and CARA software. It provides an overview of CARA's capabilities for regulatory information management, submissions management, and other regulatory and clinical processes. It highlights CARA's flexibility and ability to support multiple use cases across the product lifecycle from development through commercialization. Examples of large life sciences companies using CARA for regulatory information management and submissions are also provided.
Controlling
Controlling is one of the most important management processes and involves determining if objectives have been achieved and if the objectives were appropriate. An effective control system links activities to organizational objectives and focuses on positive performance rather than blame. It also ensures employees understand expectations. Regular audits and feedback help evaluate performance and ensure improvements. Maintaining accurate records management manuals that describe policies, responsibilities, and procedures is crucial for effective control of records systems. The manuals should be tailored to an organization's needs and activities.
Importance of nursing informatics in health care delivery
Nursing informatics is the integration of nursing, information management, and information technology to support health care. In the Philippines, nursing informatics education and electronic health records can help improve documentation, communication, and patient outcomes. However, most Philippine hospitals still rely on paper records and have yet to fully adopt electronic systems. Developing nursing informatics and electronic health records according to local needs could help address issues like high nurse-patient ratios and promote safer, higher quality care.
Meter Data Management 2.0
The fact that a Meter Data Management (MDM) system is the single, secure repository for the millions of data points collected by an AMI makes it the logical solution for data analytics such as validation, editing and estimation that improve the accuracy of billing information. Yet, as a single-source system of record, the MDM also is the starting point for integration of meter-read data with other enterprise systems to improve real-time efficiency of network operations and business processes.
The MDM with meter modelling components and standardized connectivity can integrate with the utility geodatabase (GIS) and outage management system (OMS) to significantly streamline outage detection and restoration verification.
MDM integrated with the utility supervisory control and data acquisition (SCADA) system or distribution management system (DMS) allows comparison of information at substation/net-stations with aggregated meter data to detect potential theft or network loss during distribution. Similar aggregate comparison helps analyse power quality, identify demand trending and forecast demand. These network analysis capabilities empower accurate asset planning and the utility’s ability to meet demand without adding more capacity.
In all of these enterprise-level functions, MDM integration with the GIS provides valuable visualization that facilitates operator and analyst identification of areas of concern or opportunity.
The real-time network intelligence possible with such a powerful MDM solution can return substantial benefits to several utility operations and business processes — well beyond the initial-level billing accuracy improvement.
NURSING INFORMATICS.pptx
This document discusses nursing informatics topics including nursing records and reports, management information systems, electronic health records, telemedicine, and telenursing. It provides definitions and discusses the importance, types, and best practices for nursing records and reports. Records and reports are important for documenting care, communication between providers, and evaluating services. The document also defines management information systems and describes their objectives and importance for supporting strategic goals, planning, and evaluating health programs.
Modul diktat kuliah sia
Sistem informasi akuntansi merupakan strategi dan alat yang mampu mengendalikan transaksi perusahaan dan asetnya, mencakup data keuangan dan nonkeuangan untuk memperoleh informasi ekonomis yang akurat. Tujuan mempelajari sistem informasi akuntansi antara lain untuk menyediakan informasi yang relevan, akurat dan tepat waktu dalam pengambilan keputusan bisnis.
How to Become a Chief Data Officer - The 5 Golden Rules to Achieve Success
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Presentation delivered at DAMA Puget Sound on June 9th, 2015
How to conduct a records and information inventory
This document outlines the process for conducting a records and information inventory. It describes identifying the purpose and scope of the inventory, gathering key information about records like their source, format, location, and users. The process involves identifying departments, prioritizing the inventory, reviewing work processes and repositories, interviewing staff, and creating a log of all repositories and a final organization-wide inventory. The goal is to understand an organization's information environment and identify issues to improve records and information management.
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Leeann Sills presents on the topic of nursing informatics. Nursing informatics involves using computers and information technology to support nursing practice, education, research, and administration. It aims to help manage and process nursing data and information to support decision making. Some key benefits include improved access to patient records, decreased data entry redundancy, and increased time for patient care through automation. Challenges include upfront costs, need for training, and ensuring privacy and security of patient information. Nursing informatics is still emerging but will continue growing in importance as health care delivery increasingly relies on technology.
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Makalah sistem informasi akuntansi spsdp (studi kasus pt. surabaya wire) kel. 3
Ringkasan dokumen tersebut adalah:
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2. ERP merupakan sistem informasi yang mengintegrasikan proses bisnis perusahaan.
3. Dokumen ini membahas konsep, manfaat, risiko dan contoh produk ERP terkemuka seperti SAP, JD Edwards, Oracle dan PeopleSoft.
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GenerisCorp provides pharmacovigilance case management and content storage solutions using their CARA platform. CARA allows for full PV case management or integration with third party systems like ARGUS or ARIS Global. It provides secure storage of safety data in the cloud or on-premise. Use of CARA can reduce costs through licensing savings, consolidated case processing, and deduplication of records. CARA also maintains documents from global sites in a centralized and 21 CFR Part 11 compliant repository.
CARA for IDMP
The document discusses CARAforIDMP, a software that helps companies manage regulatory identity management data standards. It allows companies to store standardized medicinal product data in a single repository according to ISO IDMP standards. The software extracts IDMP data from content using artificial intelligence and allows users to manage and report on the data through configurable dashboards. CARAforIDMP integrates IDMP data management with other regulatory applications and content repositories.
CARA for Legal Contracts Management
The CARA solution for Contracts Management from Generis Corp offers functionality to manage the entire lifecycle of contract documents, from initial draft through approval, negotiation, amendment, signatures, and archiving. It allows multiple simultaneous users to edit documents and includes review comments, document comparison, and email signatures. Contracts can be archived, renewed, or retired through automatic workflows.
CARA for Records Management
CARA provides full records management functionality including controlling creation, distribution, use, maintenance and disposition of records. It allows configuring audit trails that can track any user or system event along with retention periods and destruction policies for different record categories. The highly configurable system streamlines processes, reduces costs and ensures a full audit history for all classified records.
fme Product Review CARA by Generis
The document summarizes a review of Generis' new CARA platform. Key points include:
- Generis has established itself as a leading ECM vendor and CARA has been their flagship product for over 20 years.
- The new CARA platform provides greater flexibility by being platform independent and allowing usage across different content systems.
- It offers a mix of existing CARA features and new capabilities to improve the user experience.
- Generis is known for adapting CARA to customer needs rather than forcing customers to adapt to the platform.
Cara for RIM - planning, tracking and registration
CARA is a regulatory management software that allows companies to plan, track, and register products. It enables users to create products, regulatory applications for multiple markets, events associated with each application, and submission packages. CARA also helps users manage correspondence, commitments, and close events once approved, while registering products and tracing them back to source documents.
CARA for GxP Quality documents
Generis CARA now provides a preconfigured module for Quality / SOP / GxP documentation, based on the DIA Reference Model. CARA is the innovative and leading user interface for Documentum providing easy and fast user functionality, together with a comprehensive configuration toolbox.
The module is a preconfigured package of the standard CARA product to provide functionality required for managing all kinds of Quality Management (including SOP) documentation.
CARA: Connector for CARA/Documentum and Argus
USDM develops a connector that allows Argus systems to be integrated directly with CARA for Documentum.
CARA for Documentum - automatic image tagging
CARA can automatically tag images stored in Documentum by calling image tagging engines to extract information from images on import or when a user tags an image. This extracted information is then added to configured attributes in Documentum, avoiding the need to manually tag images. Users can also check images directly into Documentum from Office applications like Word or PowerPoint through an added ribbon.
CARA for Documentum - SharePoint simulteneous co-authoring
Allow multiple authors to work on a document simultaneously, seeing each others' changes in real-time, all driven from CARA directly to Word
CARA for Documentum - work directly in MS Word
CARA on Documentum allows users to access Documentum repositories directly from Microsoft Office applications like Word and Excel. It adds a ribbon to Office that lets users search for, open, check out, and check in documents from Documentum without leaving their Office program. Users can save documents directly back to Documentum from the Office ribbon to avoid the double work of saving in Office and then checking documents back in separately.
Cara v3 8 major new features
This document outlines new features in version 3.7 of CARA, an ergonomically designed web interface and business rules engine for document management platforms. Major new features include a content transfer plugin for one-click editing and batch importing/exporting of files, a tabbed interface for document lists, enhanced workflows, and extended customization and multi-lingual support options.
Documentum: Life after Java Applets
Documentum: content transfer has relied on Java Applets or the less user-friendly HTML5 options with limited functionality. CARA now offers a plug-in approach that provides all the ease of use of the Java Applet without the issues. It also allows direct upload from Windows Explorer / Mac Finder and also Outlook.
CARA for Pharmaceutical Labelling documents
Labelling made simple
Managing Labelling documentation is a complex matter for Life Sciences companies, given not only the variety of the documents (Core Data Sheets through to individual labels for different dosage forms, strengths and markets), but also the need for managing translations, regulatory affairs interactions internally and with authorities, the changing industry regulations for such content, and the need to interact with Product Supply and integrate feedback loops from new safety / efficacy data and regulatory directives. CARA allows this complexity to be handled in a secure and simple way.
CARA provides tools for:
> Structured authoring - Author individual components that are collated to single labels
> Submission and production integration - Seamlessly integrate the label documents with both labelling production systems and submission systems
> Master Data Management - Integrate seamlessly with a variety of master data management systems (product information) or manage it in CARA
> Where Used - Easily track and trace where each version of each label has been submitted and approved during which date period
> Translations - Manage translations of labels including providing a portal access via CARA to translation companies
CARA for eTMF (electronic Trial Master Files)
CARA for eTMF is a clinical trial management software package configured for managing electronic trial master file documentation. It is based on an electronic data management reference model. The software allows users to create eTMF structures and documents from configurable templates. It also provides secure external access for investigators and integrations with clinical trial management systems.
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CARA for RIM
- 1. for Regulatory Information Management (RIM) Do you need to know: What is approved, and where, globally? What your affiliates have done locally? The plans and status of all ongoing regulatory work? CARA provides this in a few easy clicks
- 2. CARA provides the optimal solution to the situation – allowing companies to have a single UI for RIM that simplifies the business users’ experience, with the RIM data seamlessly connected to submission assemblies and individual documents, allowing full traceability, impact analysis and an easy Current Approved View of your products globally. TheRIMlifecycleofpharmaceuticalproductsfromearlydiscovery,through development and trials to submission and post-submission tracking, updates, lifecycles and pharmacovigilance, is extremely complex. At the heart of managing the process is a combination of the Master Data on products and the documentation associated with every step of the process. Traditionally, managing these has involved implementing multi- ple silo systems with very little inter-system communication and thus data integrity.
- 3. How does it work? The CARA RIM modules provides a pre-config- ured set of data objects to manage all RIM data. At the heart is a set of Controlled Vocabularies (dosage forms, strengths, indications and so on) that are based on IDMP / SPOR. The next layer is the company Product information, from prod- uct families down to Medicinal Products and Packaged products, as well as substance and studies management. These two layers togeth- er capture the information required for IDMP / xEVMPD purposes, and can be further config- ured to individual customer needs, as well as acting as a Master Data Management system that other systems can query via REST API. Finally, there are the Events, Activities, Applica- tions and Registration objects, that are linked in a cascading fashion to each other, with automa- tions during bulk creation of e.g. Activities from Events. Every object has planned and actual dates and responsibilities data that can be used for plan- ning and then for tracking through report dash- boards. They also have a unique ability to have supporting documents attached that are not in- tended for submission but use reference during the process. All of this is support by the new Business Process Management capabilities of CARA that move simple document workflows to the next level. CARA RIM COMPONENTS Submission Forecasting / Planning Dossier (Assembly) Management Document Management Applications, Events and Activities Product Registration Commitment Management Health Authority Interactions (Q&A, correspondence) Regulatory Archive of published submissions Labelling (CCDS to labels, translations and artwork) Reporting and Analytics / Integrated Regulatory Information Data Management and Information Standards Design History File – Medical Device Regulatory Intelligence (2021) Safety Reporting / submissions Dossier publishing with our publishing partners See our main LIFE SCIENCE SOLUTIONS page for details of each of the modules. Over470,000users andgrowing…