Munich, Germany - 12 October 2020 - EXTEDO, a leading provider of Regulatory Information Management solutions, today announced the launch of a complete DMS solution to help their clients with project implementation, planning, preparation, and validation processes. The product addresses critical requirements for submission and validation processes while enabling incremental adjustments to support the demanding needs of life sciences companies.
Solutions for the life sciences industry require a highly complex development cycle. Each solution consists of the contributions of many role-players with multiple steps of validation and review. Managing clinical trials, tracking quality processes, and organizing regulatory submissions demand extreme attention to detail, accuracy, and consistency.
EXTEDO’s eDOCSmanager consists of five modules to take projects from implementation to quality assurance. The Regulatory, Clinical eTMF, Site Monitoring, SOP, and Quality modules work together with other EXTEDO solutions to provide a complete overview of projects and submissions. Some of the noteworthy features of eDOCSmanager include managing administrative and archiving tasks with drag-and-drop functionality, using templated forms and documents, automating workflows, and generating a complete record of activities.
“With eDOCSmanager, we now offer a complete RIM solution for life sciences organizations. Our customers can manage their projects from conception to completion using the comprehensive DMS solution to support their effortless compliance”, says Martin Schmid, Managing Director of EXTEDO.
eDOCSmanager promises to be a user-friendly, fully validated SaaS (Software as a Service) solution that can be implemented within days. As a cloud-based solution, the lower cost associated with the product substantially reduces deployment and operating costs, while end-end data encryption guarantees security.
In addition to this, the seamless integration with EXTEDO’s submission management solutions ensures that the publishing process for any life sciences organization is simplified, fast and effective. EXTEDO’s eDOCSmanager is compliant with FDA CFR 21 Part 11, ISO 27001 certified and validated following GAMP 5 guidelines. For more information on eDOCSmanager or the rest of EXTEDO’s products, contact EXTEDO today.
eDOCSmanager is a cloud-based DMS explicitly designed for the life sciences industry. It enables organizations to manage and monitor their projects and submissions while keeping all relevant information and data centralized.
eCTDmanager is an easy-to-use solution for building, viewing, validating, and publishing compliant submissions that meet global regulatory specifications.
eSUBmanager provides a modern, end-to-end solution that improves the collaborative review process surrounding submission content and metadata in readiness for transmission to the publishing system.
EXTEDO is a leading solutions and services provider in the field of Regulatory Information Management (RIM). We focus on optimizing our clients’ eRegulatory business processes and provide solutions covering the entire regulatory landscape. Our EXTEDOpulse solution offering combines innovation with compliance and quality with usability.
We offer planning & tracking, product registration, document management, submission management, pharmacovigilance management, and drug safety solutions to optimize every eRegulatory business process. Today, EXTEDO enables more than 35 regulatory authorities and 850 maintained customers across 60 countries to deliver Effortless Compliance™.