MedXview : Software

Technology: Experience the eCentral Advantage!

MedXview,Inc. is a global provider of regulatory software solutions for several niches within the life science’s industry including brand pharma, generic drug manufacturers, and medical device organizations. MedXview’s software and service offerings ensure that our clients meet the strict standards of regulatory authorities across the world, helping them achieve quality, accuracy, and data integrity to deliver regulatory reports and submissions reliably and on time.

eCentral: An all-inclusive server based regulatory guided platform to support and facilitate content and document management, business process workflow design and execution, and regulatory publishing task performance tracking, to increase business performance and efficiency.  

eComposer: eCentral’s globally deployable and all inclusive electronic submission publishing module designed to facilitate specific regional requirements for regulatory agencies around the world.  eComposer allows users to leverage currently deployed document and content management systems, enabling total document and submission lifecycle management and precise tracking of your regulatory submission status.

eCompliance: eCentral’s Data publishing module designed to facilitate compliance with emerging CDISC requirements including the SDTM, ODM, CDASH, SEND, and CRT-DDS models. eCompliance can be utilized in SAS Analysis and Standardization tasks as well as the successful generation and publishing of Data Definition Tables in the PDF and XML format for inclusion in eSubmissions.  

SPL Editor™: An MS Word embedded XML Editing solution to facilitate the creation and management of Content of Labeling files in the newly required PLR Compatible SPL format, complete with document validation according to precise FDA standards.

PDF Editor™: A robust and versatile server based solution for PDF management, modification (book-marking, linking, pagination etc.) and standardization that will significantly ease the task of creating “eSubmission Ready” documentation from non-standardized and seemingly disparate document sources.  

eAuthor™:  A complete set of MS Word document templates designed to guide submission content authors toward proper document formatting, styling, and content inclusion in accordance with the eCTD standard.  eAuthor™ includes a unique document template for every level of eCTD granularity and can be deployed for full integration within eCentral™ and MS Word.    

Repository and Workflow Function within eCentral

eCentral Repository
Provides distributed magnetic, database, optical, and content-addressable storage alternatives for long-term archive storage. Offers document tracking, management, organization, version control and security functionality for diverse file formats: faxes, e-mail, spreadsheet, scanned images, manufacturing diagrams, and text. Organizes and aggregates documents for business process speed and enhanced productivity.

Enables process execution to tie in directly with business objectives, automatically adjusting business processes.

eCentral Workflow Engine™
Provides up-to-the-moment statistics about productivity, workloads, goal attainment, and process anomalies giving managers the ability to drill down on data and “slice and dice” from different perspectives.

Workflow Manager™
Enables quick automation, organization, and aggregation of documents to improve business process speed and enhance productivity.  Organizations gain unprecedented visibility and control over their operations and achieve a unified and integrated view of related information.

Process Manager™
Allows definition of business processes, manages guidelines for process execution, and tracks both business goals being supported by the process and the people who perform them.
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