CARA for eTMF (electronic Trial Master Files)
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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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Benefits of an eTMF system
The document discusses electronic Trial Master File (eTMF) systems. It defines an eTMF as a formal way to organize and store documents and files required by regulatory agencies for clinical trials. eTMF systems can facilitate efficiencies in trials through improved document collection and management. The key to implementing interoperable eTMF systems is using standards-based models, vocabularies, and web technologies. DBI's cloud-based eTMF platform provides real-time access to clinical documents throughout a trial. Their flat rate licensing fee helps maintain budgets and allows flexibility.
Transforming eTMF Management: Moving to a Data-Driven Approach
We are moving towards a digital age of automation in clinical trials where electronic management of content and data to document activities and decisions is the industry-wide norm.
This means that the concept of TMF is also evolving and is no longer just a document repository, but rather a collection of systems holding content and data. As a result, there is a strong business case from moving away from just archiving documents to actively managing TMF content and information using techniques and practices borrowed from clinical data management.
In this webinar, we will look at how you can use queries, data review and process-based approaches to ensure that your TMF tells an accurate and complete story of what occurred in your study. We will also discuss the greater scope of TMF relevant information and systems and how you can best integrate these sources into a more holistic environment to greatly facilitate inspections and clinical trial oversight.
Powering your TMF for Inspection Readiness
Presentation from the 2016 MAGI West conference on how to prepare your organization for inspection readiness by focusing on processes, governance, and tools.
eTMF in the fast lane
Learn about the Trial Master File, eTMF and how efficiencies can be during the clinical trial process.
From Vision to Implementation: A Complete, Consistent and Compliant eTMF
Pfizer partnered with Wingspan to develop an electronic Trial Master File (eTMF) system to transform their document management processes. They spent 10 months defining requirements and selected Wingspan based on their capabilities. Wingspan then spent 5 months designing a highly optimized system. The teams worked closely over 12 months to deliver the system, meeting all milestones on time. The new eTMF provides complete, compliant and consistent management of studies and documents for Pfizer's global clinical trials.
Practical considerations for eTMF Planning
The document discusses a webinar on practical considerations for electronic trial master file (eTMF) planning presented by Paragon Solutions. The webinar covered why organizations are moving to robust eTMF systems, the necessary people, process and technology requirements, and insights into maturity models for eTMF implementation. The presentation addressed factors driving the transition to eTMF, considerations for change management and information architecture, and the need to challenge perceptions of regulatory requirements.
eTMF ppt
An eTMF is an electronic system for organizing and storing documents related to clinical trials. It replaces paper regulatory binders with electronic storage in a computer server or cloud. Key benefits include increased compliance, efficiency, transparency, and cost savings compared to paper-based systems. While adoption of eTMFs is growing, challenges remain around scope, performance for large document volumes, and change management for training users.
Implementing the TMF Reference Model
Since its release in 2010, The DIA’s TMF Reference Model has proven to be extremely valuable to the life sciences industry. In this content-packed webinar, we will provide a history and overview of the Model, present its structure, and the various sub-groups and resources available. The Model is not intended to be used “off-the-shelf" but can be implemented according to certain expectations and requirements of life science sponsors (pharma, bio, device), investigative sites (academic, for-profit, nonprofit) and CROs / third-party team members alike.
Paul Fenton, CEO of Montrium and CGI Life Science’s Fran Ross, both Members of the TMF Reference Model Steering Committee, will discuss strategies for implementing the Model and how it can be used to ensure tight controls of GxP required content for inspection. Finally, the session will present the TMF Reference Model Exchange Mechanism Standard which extends the Model's capability to facilitate eTMF interoperability and content exchange.
Recommended
Benefits of an eTMF system
The document discusses electronic Trial Master File (eTMF) systems. It defines an eTMF as a formal way to organize and store documents and files required by regulatory agencies for clinical trials. eTMF systems can facilitate efficiencies in trials through improved document collection and management. The key to implementing interoperable eTMF systems is using standards-based models, vocabularies, and web technologies. DBI's cloud-based eTMF platform provides real-time access to clinical documents throughout a trial. Their flat rate licensing fee helps maintain budgets and allows flexibility.
Transforming eTMF Management: Moving to a Data-Driven Approach
We are moving towards a digital age of automation in clinical trials where electronic management of content and data to document activities and decisions is the industry-wide norm.
This means that the concept of TMF is also evolving and is no longer just a document repository, but rather a collection of systems holding content and data. As a result, there is a strong business case from moving away from just archiving documents to actively managing TMF content and information using techniques and practices borrowed from clinical data management.
In this webinar, we will look at how you can use queries, data review and process-based approaches to ensure that your TMF tells an accurate and complete story of what occurred in your study. We will also discuss the greater scope of TMF relevant information and systems and how you can best integrate these sources into a more holistic environment to greatly facilitate inspections and clinical trial oversight.
Powering your TMF for Inspection Readiness
Presentation from the 2016 MAGI West conference on how to prepare your organization for inspection readiness by focusing on processes, governance, and tools.
eTMF in the fast lane
Learn about the Trial Master File, eTMF and how efficiencies can be during the clinical trial process.
From Vision to Implementation: A Complete, Consistent and Compliant eTMF
Pfizer partnered with Wingspan to develop an electronic Trial Master File (eTMF) system to transform their document management processes. They spent 10 months defining requirements and selected Wingspan based on their capabilities. Wingspan then spent 5 months designing a highly optimized system. The teams worked closely over 12 months to deliver the system, meeting all milestones on time. The new eTMF provides complete, compliant and consistent management of studies and documents for Pfizer's global clinical trials.
Practical considerations for eTMF Planning
The document discusses a webinar on practical considerations for electronic trial master file (eTMF) planning presented by Paragon Solutions. The webinar covered why organizations are moving to robust eTMF systems, the necessary people, process and technology requirements, and insights into maturity models for eTMF implementation. The presentation addressed factors driving the transition to eTMF, considerations for change management and information architecture, and the need to challenge perceptions of regulatory requirements.
eTMF ppt
An eTMF is an electronic system for organizing and storing documents related to clinical trials. It replaces paper regulatory binders with electronic storage in a computer server or cloud. Key benefits include increased compliance, efficiency, transparency, and cost savings compared to paper-based systems. While adoption of eTMFs is growing, challenges remain around scope, performance for large document volumes, and change management for training users.
Implementing the TMF Reference Model
Since its release in 2010, The DIA’s TMF Reference Model has proven to be extremely valuable to the life sciences industry. In this content-packed webinar, we will provide a history and overview of the Model, present its structure, and the various sub-groups and resources available. The Model is not intended to be used “off-the-shelf" but can be implemented according to certain expectations and requirements of life science sponsors (pharma, bio, device), investigative sites (academic, for-profit, nonprofit) and CROs / third-party team members alike.
Paul Fenton, CEO of Montrium and CGI Life Science’s Fran Ross, both Members of the TMF Reference Model Steering Committee, will discuss strategies for implementing the Model and how it can be used to ensure tight controls of GxP required content for inspection. Finally, the session will present the TMF Reference Model Exchange Mechanism Standard which extends the Model's capability to facilitate eTMF interoperability and content exchange.
Experience with eTMF and Site Archiving
The document discusses the evolution of electronic document management (EDM) and electronic trial master files (eTMF) in clinical trials. It notes that while EDM and electronic data capture have improved, most investigative sites still rely heavily on paper files. A survey found sites face issues like duplication of work between electronic and paper systems. The presentation calls for simplifying technologies and adopting fully electronic investigative site files and master files to improve efficiency for sites and clinical research associates. Overall it analyzes the current challenges with electronic documentation in clinical trials and the need for further progress.
Electronic trial master filest
An electronic Trial Master File (eTMF) provides advantages over the traditional paper TMF model that is still commonly used in Europe. An eTMF allows documents to be centralized in one electronic location that can be accessed from anywhere at any time, providing visibility, backup protection, and reducing duplication. However, implementing an effective eTMF requires changes to workflows and consideration of all documentation sources and stakeholders to maximize the benefits of process enhancements and improved data security that an eTMF can provide.
Clireo eTMF Solution by arivis
Clireo eTMF Solution by Arivis
What is Clireo?
• Comprehensive Software and Service enabling the Trial Master File
• Compliant with the DIA Trial Master File Reference Model Version 3
• Assign access and maintain control of Sites, Vendors, and Auditors for content.
• Eliminate CRA need to reconcile the Investigator Site File against the Sponsor TMF.
• Part 21 CFR 11 Digital signatures allow for faster turn around time on documents.
• Ability to quickly disseminate new information to users that the information is relevant to.
• Vendors and Sites can upload documentation and data directly into Clireo.
• Unlimited storage capacity assures that all documentation can be held in one location.
• No additional hardware required to implement.
• Dashboard reports on the status of sites and documents to easily identify missing or lagging information.
• Protect documents against unauthorized modification.
• Supports single or multiple file uploads with single screen metadata tagging.
• Centralized Documentation-Access from Anywhere.
• Resolve document issues faster.
• Ability to search documents in many ways.
• Dramatic Reduction in the need to print, scan, and store multiple copies in several locations.
• Link documents together to create a complete document package.
We have been serving eTMF customers since 2007.
Email now to schedule a demonstration and see how Clireo and Arivis can help you with your eTMF needs.
Tricia McQuarrie
Clinical Operations Manager tricia.mcquarrie@arivis.com
Arivis, Inc.
2198 E. Camelback Road
Phoenix, AZ 85016
Tel. 602-957-2150
www.m3.arivis.com
Ensuring a Quality Trial Master File
The document outlines the six elements of the quality control process for a Trial Master File: 1) careful planning, 2) desired level of quality, 3) proper equipment, 4) verification, 5) continued inspection, and 6) corrective action. It states that quality control for a TMF is a systematic process that addresses expectations, relies on planning, and requires predetermined benchmarks, verification, evaluation and continued inspection. Performing a quality control review based on expected document types rather than just inventory ensures the TMF is complete, accurate and ready for inspection.
Webinar on eTMF – Challenges, Opportunities & Trends
MakroCare’s eTMF solutions help clients minimize cumbersome paper document management and routine pain points of TMF compliance.
Practical Application of the TMF Reference Model Webinar
This webinar provided an overview of the TMF Reference Model and practical steps for organizations to implement it. It discussed the background and purpose of the model, how it standardizes trial master file content. The webinar also covered strategies for conducting an information architecture assessment, differentiating issues, leveling the playing field among stakeholders, preparing tools and getting the job done of adopting the model. It concluded with a discussion of specific artifact considerations, suggested additions to the model, and metadata functions.
Advance Information Management Through eTMF and CTMS Convergence
With the increasing need for oversight of studies taking place across the globe, effective TMF management through an eTMF is just the tip of the iceberg for enhancing your organizations’ collaboration strategies. By utilizing an eTMF in conjunction with a CTMS, the opportunity to improve management of information is afforded.
Practical Steps to Selecting and Implementing an eTMF
This webinar presentation provided an overview of practical steps for selecting and implementing an electronic trial master file (eTMF). It began with an introduction and housekeeping items. It then covered the changing regulatory landscape around eTMF requirements. Key challenges and the future of eTMF were discussed. The presentation outlined the process for eTMF vendor selection and provided tips for a successful implementation. It emphasized the importance of planning, change management, and adopting the TMF Reference Model.
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The document provides an overview of a webinar on TMF fundamentals presented by Montrium. The webinar agenda includes an introduction to Montrium, defining what a TMF is, common TMF challenges and how to alleviate them, leveraging regulations to ensure success, using basic metrics to better manage the TMF, and advantages of an electronic TMF. Key topics discussed include the TMF reference model, roles and responsibilities, tips for managing the TMF including clear governance and technology, and how an eTMF can help with collaboration, oversight, inspection readiness and metrics.
Clinical Trial Management System Implementation Guide
This document provides guidance on planning and implementing a clinical trial management system (CTMS). It discusses signs that a CTMS is needed, benefits of a CTMS, preparing to explore CTMS options by analyzing needs and identifying key stakeholders. It also covers developing requirements, selecting a system, choosing an implementation partner, and post-implementation support. The goal is to select and implement a CTMS in a strategic manner to reduce costs, increase efficiency and productivity for clinical trial management.
Managing Global Studies with Oracle's Siebel Clinical Trial Management System...
The document discusses how clinical trials are increasingly being conducted globally to reduce costs. It presents three case studies of companies using Oracle's Siebel Clinical Trial Management System (CTMS) to manage global studies. Key challenges include communication across countries, varying regulatory requirements, and financial management in different currencies. Siebel CTMS addresses these through features like multi-language support, customizable templates for documents and activities, and currency conversions. The presentation concludes with a demo of Siebel CTMS and a Q&A section.
Laboratory Information Management System
A Laboratory Information Management System (LIMS) is a software solution used in laboratories to manage large amounts of sample data and laboratory workflow. It typically handles five key phases: sample receipt and login, assignment and tracking, processing and quality control, data storage, and result reporting. A LIMS provides advantages like faster access to reports, reduced errors, improved efficiency and productivity. However, it also requires training, time for adaptation, costs for purchase and maintenance, and backup systems in case of data loss. Laboratories must ensure proper management, security and validation of any LIMS.
LIMS
This document discusses Laboratory Information Management Systems (LIMS). It begins by defining LIMS as a method laboratories use to manage data and disseminate results. It then discusses why LIMS are important for managing the information explosion, ensuring quality assurance, and reducing errors. The document outlines different types of laboratories that use LIMS, including research, testing, and manufacturing labs. It concludes by discussing how laboratories can determine their LIMS needs and options for acquiring a system through a systems analysis approach.
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Here we cover the following topics:
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Outsourcing TMF Management
In our upcoming webinar, we will be exploring how dividing responsibilities between CRO and Sponsor in an outsourcing model can be leveraged to improve the quality of your trials. We'll start by diving in to the world of outsourcing and what roles different organizations can play, and then explore some of the ways technology can enable outsourced TMF management to operate smoothly.
Medical laboratory software
Charisma Medical Software provides an end-to-end laboratory solution that automates all activities from sample intake to results and invoicing, helping to reduce turnaround times and eliminate errors. The solution has been implemented in Romania's largest labs and offers features ranging from basic request and result entry to integration with over 120 analyzers and electronic medical records. With over 15 years of experience, Charisma serves over 1,000,000 patients through its solutions used in many major medical institutions and pharmaceutical companies in Romania.
eCTD in Australia and Experience in the Pilot Programme
The document discusses Australia's implementation of electronic Common Technical Document (eCTD) format submissions and lessons learned from a pilot program. Key points include:
- Australia published a final eCTD specification in April 2015 and will require its use starting January 2016.
- When submissions arrive, they are checked for validation and completeness before being reviewed.
- Reviewers navigate submissions using hyperlinks and bookmarks within a review tool, so these elements must be well-implemented.
- Tips are provided to sponsors for organizing PDFs, leaf titles, and operator attributes to facilitate review.
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Keeping up with the fast-evolving world of trends means that smart work with innovation is required. Having a smart-infrastructure built on informatics solutions can benefit the lab by implementing automation. Laboratory Information Management System (LIMS) is a critical part of the system to be incorporated in all functioning laboratories for better results.
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Experience with eTMF and Site Archiving
The document discusses the evolution of electronic document management (EDM) and electronic trial master files (eTMF) in clinical trials. It notes that while EDM and electronic data capture have improved, most investigative sites still rely heavily on paper files. A survey found sites face issues like duplication of work between electronic and paper systems. The presentation calls for simplifying technologies and adopting fully electronic investigative site files and master files to improve efficiency for sites and clinical research associates. Overall it analyzes the current challenges with electronic documentation in clinical trials and the need for further progress.
Electronic trial master filest
An electronic Trial Master File (eTMF) provides advantages over the traditional paper TMF model that is still commonly used in Europe. An eTMF allows documents to be centralized in one electronic location that can be accessed from anywhere at any time, providing visibility, backup protection, and reducing duplication. However, implementing an effective eTMF requires changes to workflows and consideration of all documentation sources and stakeholders to maximize the benefits of process enhancements and improved data security that an eTMF can provide.
Clireo eTMF Solution by arivis
Clireo eTMF Solution by Arivis
What is Clireo?
• Comprehensive Software and Service enabling the Trial Master File
• Compliant with the DIA Trial Master File Reference Model Version 3
• Assign access and maintain control of Sites, Vendors, and Auditors for content.
• Eliminate CRA need to reconcile the Investigator Site File against the Sponsor TMF.
• Part 21 CFR 11 Digital signatures allow for faster turn around time on documents.
• Ability to quickly disseminate new information to users that the information is relevant to.
• Vendors and Sites can upload documentation and data directly into Clireo.
• Unlimited storage capacity assures that all documentation can be held in one location.
• No additional hardware required to implement.
• Dashboard reports on the status of sites and documents to easily identify missing or lagging information.
• Protect documents against unauthorized modification.
• Supports single or multiple file uploads with single screen metadata tagging.
• Centralized Documentation-Access from Anywhere.
• Resolve document issues faster.
• Ability to search documents in many ways.
• Dramatic Reduction in the need to print, scan, and store multiple copies in several locations.
• Link documents together to create a complete document package.
We have been serving eTMF customers since 2007.
Email now to schedule a demonstration and see how Clireo and Arivis can help you with your eTMF needs.
Tricia McQuarrie
Clinical Operations Manager tricia.mcquarrie@arivis.com
Arivis, Inc.
2198 E. Camelback Road
Phoenix, AZ 85016
Tel. 602-957-2150
www.m3.arivis.com
Ensuring a Quality Trial Master File
The document outlines the six elements of the quality control process for a Trial Master File: 1) careful planning, 2) desired level of quality, 3) proper equipment, 4) verification, 5) continued inspection, and 6) corrective action. It states that quality control for a TMF is a systematic process that addresses expectations, relies on planning, and requires predetermined benchmarks, verification, evaluation and continued inspection. Performing a quality control review based on expected document types rather than just inventory ensures the TMF is complete, accurate and ready for inspection.
Webinar on eTMF – Challenges, Opportunities & Trends
MakroCare’s eTMF solutions help clients minimize cumbersome paper document management and routine pain points of TMF compliance.
Practical Application of the TMF Reference Model Webinar
This webinar provided an overview of the TMF Reference Model and practical steps for organizations to implement it. It discussed the background and purpose of the model, how it standardizes trial master file content. The webinar also covered strategies for conducting an information architecture assessment, differentiating issues, leveling the playing field among stakeholders, preparing tools and getting the job done of adopting the model. It concluded with a discussion of specific artifact considerations, suggested additions to the model, and metadata functions.
Advance Information Management Through eTMF and CTMS Convergence
With the increasing need for oversight of studies taking place across the globe, effective TMF management through an eTMF is just the tip of the iceberg for enhancing your organizations’ collaboration strategies. By utilizing an eTMF in conjunction with a CTMS, the opportunity to improve management of information is afforded.
Practical Steps to Selecting and Implementing an eTMF
This webinar presentation provided an overview of practical steps for selecting and implementing an electronic trial master file (eTMF). It began with an introduction and housekeeping items. It then covered the changing regulatory landscape around eTMF requirements. Key challenges and the future of eTMF were discussed. The presentation outlined the process for eTMF vendor selection and provided tips for a successful implementation. It emphasized the importance of planning, change management, and adopting the TMF Reference Model.
Tmf Fundamentals - webinar
The document provides an overview of a webinar on TMF fundamentals presented by Montrium. The webinar agenda includes an introduction to Montrium, defining what a TMF is, common TMF challenges and how to alleviate them, leveraging regulations to ensure success, using basic metrics to better manage the TMF, and advantages of an electronic TMF. Key topics discussed include the TMF reference model, roles and responsibilities, tips for managing the TMF including clear governance and technology, and how an eTMF can help with collaboration, oversight, inspection readiness and metrics.
Clinical Trial Management System Implementation Guide
This document provides guidance on planning and implementing a clinical trial management system (CTMS). It discusses signs that a CTMS is needed, benefits of a CTMS, preparing to explore CTMS options by analyzing needs and identifying key stakeholders. It also covers developing requirements, selecting a system, choosing an implementation partner, and post-implementation support. The goal is to select and implement a CTMS in a strategic manner to reduce costs, increase efficiency and productivity for clinical trial management.
Managing Global Studies with Oracle's Siebel Clinical Trial Management System...
The document discusses how clinical trials are increasingly being conducted globally to reduce costs. It presents three case studies of companies using Oracle's Siebel Clinical Trial Management System (CTMS) to manage global studies. Key challenges include communication across countries, varying regulatory requirements, and financial management in different currencies. Siebel CTMS addresses these through features like multi-language support, customizable templates for documents and activities, and currency conversions. The presentation concludes with a demo of Siebel CTMS and a Q&A section.
Laboratory Information Management System
A Laboratory Information Management System (LIMS) is a software solution used in laboratories to manage large amounts of sample data and laboratory workflow. It typically handles five key phases: sample receipt and login, assignment and tracking, processing and quality control, data storage, and result reporting. A LIMS provides advantages like faster access to reports, reduced errors, improved efficiency and productivity. However, it also requires training, time for adaptation, costs for purchase and maintenance, and backup systems in case of data loss. Laboratories must ensure proper management, security and validation of any LIMS.
LIMS
This document discusses Laboratory Information Management Systems (LIMS). It begins by defining LIMS as a method laboratories use to manage data and disseminate results. It then discusses why LIMS are important for managing the information explosion, ensuring quality assurance, and reducing errors. The document outlines different types of laboratories that use LIMS, including research, testing, and manufacturing labs. It concludes by discussing how laboratories can determine their LIMS needs and options for acquiring a system through a systems analysis approach.
Strategies for Conducting GxP Vendor Assessment of Cloud Service Providers - ...
Want to deploy a new technology solution but not sure where to begin? These slides cover key considerations for choosing a vendor with cloud compliance and validation in mind. With the Office 365 subscription-based service gaining considerable momentum in the life sciences, it's important to stay ahead of the technological and regulatory curve and consider how an EDMS system will bring improvements to managing your GxP content.
Here we cover the following topics:
-Vendor assessment of Microsoft
-Subscription basics of Office 365
-Review of ISO/SOC audit reports
-Ensuring that no critical observations are made
-Security and quality controls in place
You can follow along with this presentation via webinar format:
https://info.montrium.com/strategies-for-conducting-gxp-vendor-assessment-of-cloud-service-providers
Outsourcing TMF Management
In our upcoming webinar, we will be exploring how dividing responsibilities between CRO and Sponsor in an outsourcing model can be leveraged to improve the quality of your trials. We'll start by diving in to the world of outsourcing and what roles different organizations can play, and then explore some of the ways technology can enable outsourced TMF management to operate smoothly.
Medical laboratory software
Charisma Medical Software provides an end-to-end laboratory solution that automates all activities from sample intake to results and invoicing, helping to reduce turnaround times and eliminate errors. The solution has been implemented in Romania's largest labs and offers features ranging from basic request and result entry to integration with over 120 analyzers and electronic medical records. With over 15 years of experience, Charisma serves over 1,000,000 patients through its solutions used in many major medical institutions and pharmaceutical companies in Romania.
eCTD in Australia and Experience in the Pilot Programme
The document discusses Australia's implementation of electronic Common Technical Document (eCTD) format submissions and lessons learned from a pilot program. Key points include:
- Australia published a final eCTD specification in April 2015 and will require its use starting January 2016.
- When submissions arrive, they are checked for validation and completeness before being reviewed.
- Reviewers navigate submissions using hyperlinks and bookmarks within a review tool, so these elements must be well-implemented.
- Tips are provided to sponsors for organizing PDFs, leaf titles, and operator attributes to facilitate review.
Using Lims for Quality Control Process
Keeping up with the fast-evolving world of trends means that smart work with innovation is required. Having a smart-infrastructure built on informatics solutions can benefit the lab by implementing automation. Laboratory Information Management System (LIMS) is a critical part of the system to be incorporated in all functioning laboratories for better results.
Myths of validation
This document debunks 7 common myths about validating software-as-a-service (SaaS) applications in a regulated environment. It explains that cloud providers can securely store data in specific geographic locations and use encryption. It also argues that virtual servers can be validated through traceable IDs and documented system development processes. Further, pre-validated multi-tenant systems and vendor-managed updates may not require revalidation if changes are properly tested and controlled. The document aims to demonstrate that SaaS applications can meet regulatory requirements if the appropriate security, documentation and change controls are implemented and audited.
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CARA for Documentum, SharePoint and Alfresco using CMIS
CARA is the world's first full functionality user interface and configuration layer for multiple repositories based on CMIS plus repository-specific extensions. Full implementations available for Documentum, SharePoint and Alfresco, with CMIS-only implementations for other platforms (full versions to follow).
Ra framework 0.1
The RA framework provides a Java-based n-tier architecture for quickly developing web applications. It includes presentation, middleware, business, and data interface layers. The presentation layer generates user interfaces from middleware data. Middleware uses XML configuration instead of Java beans. Business logic is implemented as services. The data interface layer integrates with databases using Oracle or Hibernate frameworks. The framework aims to reduce development time through reusable and configurable components while ensuring reliability, reusability, maintainability and portability.
Selenium Tutorial for Beginners | Automation framework Basics
In this presentation, you will learn about the basics of Testing Automation framework. You will learn about the types of automation frameworks, details of these frameworks as well as pros and cons of these frameworks.
Java Selenium 3.0 Training
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http://techcanvass.com/Courses/selenium-training-course.aspx
Python Selenium 3.0 Training
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http://techcanvass.com/Courses/selenium-training-with-python.aspx
Techcanvass is a software development and training organization. We provide IT certifications training for mid-level professionals.
We specialize in the following areas:
a) Selenium v3.0 training with Java and Python
b) IIBA Business Analysis certifications (all levels)
c) Certified Agile Business Analyst Training
d) Data Science Training ( R, Python and Big Data) and Tableau
Website: http://techcanvass.com
Facebook Page: https://www.facebbook.com/Techcanvass
Twitter Handle: @techcanvass
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This is a step-by-step guide to migrating from CA AllFusionTM ERwin Data Modeler to Embarcadero ER/Studio - the next-generation data modeling solutions. Embarcadero Technologies is the leading provider of database tools and developer software.
Oracle Application Express
Overzicht van geweldige gratis technologie: Oracle application Express. Met deze tool heb ik voor vele gebruikers snel verschillende applicaties gebouwd
Ikenstudiolive
A world's one of the first complete Online Web-based Development Frameworks to develop and deploy Decision Support Systems, Knowledge-based systems, Web-sites and Applications backed by Expert System, Case-Based Reasoning and Hybrid AI Technologies
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Ordina consultant Marco Gralike gave an introduction to Oracle Enterprise Manager 12cR3. The presentation covered the architecture of OEM including the central management console, repository, agents, and targets. It highlighted key features such as centralized monitoring, event monitoring, problem management, performance summaries, and patching. Gralike also discussed experiences implementing OEM and possible alternative monitoring solutions.
ER/Studio Data Architect Datasheet
Learn more about ER/Studio Data Architect and try it free at: http://embt.co/ERStudioDA
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Info sphere overview
IBM InfoSphere Information Server 8.1 is a unified platform for understanding, cleansing, transforming and delivering trustworthy information. It combines the technologies of components like the Information Server Console, Metadata Workbench, Business Glossary, DataStage & QualityStage, Information Analyzer and Information Services Director. The platform provides shared services for administration and reporting. Metadata services allow accessing and integrating data. Key components include the Metadata Server, Metadata Workbench and Business Glossary for managing metadata. DataStage & QualityStage is used for designing jobs to transform and cleanse data, while Information Analyzer helps understand data quality.
Alfresco One (Enterprise) vs Alfresco Community 2014
Alfresco One (Enterprise) provides more robust, scalable, and supported features compared to the Community version. Key differences include being ready for production use, receiving service packs and updates, and having priority support. The Enterprise version also offers high availability, certification across platforms, 24/7 support via SLA, access to support tools and knowledge base, certified training, and support from Alfresco's partner network. It additionally supports more databases and application servers and includes certified integrations, clustering, storage policies, benchmarking frameworks, and advanced monitoring capabilities.
Database Tools - ER Studio Facts and Features
Embarcadero® ER/Studio®, an industry-leading data modeling tool, helps companies discover, document, and re-use data assets. With round-trip database support, data architects have the power to easily reverse-engineer, analyze, and optimize existing databases. Productivity gains and enforcement of organizational standards can be achieved with ER/Studio’s strong collaboration capabilities.
Php Web Frameworks
The document provides an overview of web frameworks and discusses some popular PHP frameworks including CodeIgniter, CakePHP, Zend, Symfony, Yii, and Kohana. It describes what a web framework is and some common features they provide such as data persistence, session management, security, caching, templating, and administrative interfaces. For each framework highlighted, it provides a brief description of its key features and benefits.
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CARA user interface for Documentum, Alfresco, Oracle WebCenter
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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.
CARA for RIM
The CARA Life Sciences Platform is made up of different module which make up full Regulatory Information Management.
PdFready
PDFReady provides a tool to check, fix, and optimize PDF files for regulatory submission readiness. It can automatically fix many common issues like misalignments, missing watermarks, bookmark and hyperlink problems, and pagination faults. The tool integrates seamlessly with document management systems and can be used on-premise or via their cloud service. It helps solve the problem of preparing PDF documents for submission by repairing issues that traditionally required manual work.
Cara for Quality Management
CARA is a quality management software package that allows users to manage quality documentation like SOPs and GxPs. It provides functionality for document creation, review, approval, signatures, publishing, and more. It also facilitates quality events, CAPA management, change requests, and evaluations. The package comes with pre-configured document types, metadata, workflows, and security definitions for typical quality management needs. It is designed to serve as a central platform for regulatory documentation and data across different business applications and systems.
CARA for Permits and Applications
CARA streamlines the permit application and review process, saving time and money. It allows applicants to easily submit building permit applications and attach documents through a portal. Reviewers can handle applications and their documents through CARA's task feature to issue, receive and complete tasks. Permits and documents can be issued and viewed by recipients or the public through the CARA portal, ensuring information is always up to date.
CARA for Safety
Find out more about using the CARA Workspace for Safety including PSURs, SABR, Educational Materials and Aggregate Reports.
CARA for Pharmacovigilance
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: 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.
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
DocSecure - watermarking, eSignature and Controlled Printing for Documentum, ...
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DocLink for managing hyperlinks in Documentum
DocLink is a tool that converts file system hyperlinks between documents stored in a Documentum repository to Documentum URLs, allowing the links to remain clickable when viewed from within Documentum. It scans PDFs for file path hyperlinks and changes them to Documentum links for temporary viewing without altering the source documents or MD5 checksums. This allows documents with inter-file links to be viewed within Documentum while maintaining the original file system paths for regulatory submissions.
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Speaker: Deepak Mahto, Founder of DataCloudGaze Consulting
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Venue: Bangalore International Centre, Bangalore
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Follow us on LinkedIn: https://in.linkedin.com/company/mydbops
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Dynamic. Modular. Productive.
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Multi-Runtime
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CARA for eTMF (electronic Trial Master Files)
- 1. www.generiscorp.com eTMF on Documentum / Alfresco / Oracle WebCenter DIA EDM Reference Model Document and metadata set – starting from the reference model Template-based Approach Create documents, full eTMF structure and add sites, all from templates – all fully configurable Portal / Cloud Simple and secure access for external contributors Cloud-enabled for both internal and external users CTMS and other Integrations Integrate with multiple CTMS systems within the CARA UI and push documents to submissions or pull from Quality (SOP)
- 2. CARA for eTMF CARA for electronic Trial Master Files is a configuration package of the standard CARA product to provide functionality required for managing all Clinical Trial Master File documentation and related information. This package is based on the EDM Reference Model. The CARA Portal for Investigators and Clinical Trial Sites to upload data to your repository. Additionally, the CARA Hub functionality allows you to display and update information from third party systems (e.g. CTMS, submission management, master data management) using web services, JSP or other easy integration points. CARA eTMF features General CARA features • Based on the EDM Reference Model for metadata model • eTMF template structures included • Ability to create contexts so that documents included in multiple studies can have different metadata (e.g. Investigator CVs) • De-duplication of data – manage and report on duplicate files • Wizard for creation of content based on templates • Integration with simultaneous authoring / review tools e.g. from PleaseTech, i4i and Brava • Full cycle of creation, authoring, review and approval including eSignature • Easy drag-and-drop to create and manage Trial Master Files • Use metadata and CARA dashboards to manage TMF information • Ability to have external CROs and Investigators or Trial Sites contribute documents directly into your docbase via the CARA Portal – uploading to a staging area where files can then be fully tagged • Study Tagging information for the CTD • Ability to tie TMF documents into submissions (see separate CARA Regulatory Affairs package) • Fully multi-lingual including many European languages as well as Japanese, Chinese and multiple European languages Contact us for a demo or evaluation www.generiscorp.com / info@generiscorp.com DIMENSIONS CARA has a unique ability to allow users to build their own navigation tree view (“Dimensions”) based on metadata. WIDGETS Extensible panel showing widgets – choose from core set (e.g. properties, renditions) or create your own, linking in any web service / JSP or query as a widget. Rearrange the widgets pane with drag & drop. VIEW MANAGEMENT Define different views for different user groups / usage scenarios. Specify different properties, widgets, filters, SnapLists, Dimensions and other options, allowing users to work in the way that best supports their individual processes. DASHBOARDS Dashboards provide a strong reporting capability for data both inside CARA and accessible externally via web services, and results can be shown as tables, charts or graphs, exported to Excel. USER PREFERENCES All settings that users choose to personalize are saved as their preferences, so that the user can login from another machine and will have the same preferences applied. CONFIGURABILITY CARA has a full configuration and customization layer built in to allow faster deployment and easier validation.