PIPELINE EDM™
Document management is becoming more important than ever due to the following trends in our industry that include the increasing number of electronic submissions, mergers and acquisitions, product licensing deals (in-license or out-license), the continued growth in outsourcing and the high number of 483 observations for failure to manage and control records.
As Regulatory’s function spans electronic submissions, due diligence and other clinical and quality functions, a document management system is no longer a luxury, but a necessity regardless of the size of your organization.
PIPELINE EDM includes a company-wide central repository for all documentation and data, and can extract information when building eCTD submissions.
| 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 |
| Non-clinical | 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 | Trial master file management and workflow processes |
| Safety | Manages all documentation related to drug safety reports (CIOMS and MedWatch) and safety tables and listings |
All of the modules in PIPELINE EDM closely follow the Reference Model being developed by the DIA’s SIAC (non-profit) for developing standards for document management.
