Pipeline EDM ™ from 
Moonbay Technology software applications for biotechnology and 
pharmaceutical companies
software as a service
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drug development software 
applications
Moonbay Technology
SaaS for Drug Development - Pipeline EDM from Moonbay 
Technology

Pipeline EDM™ is a hosted software-as-a-service (SaaS) application designed for biotechnology and pharmaceutical companies. This all-in-one document management and e-publishing application can meet the pending mandate for paperless submissions.

Pipeline EDM (TM) software application for drug development 
submissions

Pipeline EDM™ achieves 21 CFR Part 11 requirements through a core document management system enabling version control of documents and electronic signatures. The modules of the application are organized by work function to complement the structure of most drug development organizations. Subscription pricing of Pipeline EDM™ results in an overall lower total cost of ownership thereby allowing smaller organizations with limited IT budgets to utilize document management and electronic publishing tools. Subscriptions to Pipeline EDM™ include the selected modules, upgrades, application hosting, training, and a Technical Support Representative to provide outstanding support and service.


Key Product Features

Additional Document Management Features
Message Board Automatic notifications, recurring reminders, and message archival
Reference Library Central repository for literature references
Service Portals Secure portals for information transfer

7 Integrated Modules
Research Easy storage for research data and documentation
Nonclinical Management tools to track and store nonclinical studies and summaries
CMC Manages all data and documentation related to drug substance and drug product manufacturing
Quality Manages controlled documents (SOPs), audit and CAPA workflows, equipment tracking, and training records
Regulatory Creates and manages a submission in the eCTD format. Manages the submission lifecycle and Agency correspondence
Clinical Manages indication-specific, clinical study-related and site-related documents, tracks subjects and subject specific documentation
Safety Manages all documentation related to drug safety reports (CIOMS and MedWatch) and safety tables and listings


Contact

For more information regarding Pipeline EDM™, please contact Moonbay Technology at (888) 663-6607.


Pipeline 
EDM™ drug development software application

drug development submission softwareMoonbay Technology
biotechnology and 
pharmaceutical software applications for drug development