R&D Submission Documents Package

QUMAS R&D Submission Documents Package

The R&D Submission Documents Package offers the QUMAS DocCompliance application, together with a pre-defined configuration to support development of documentation used in submissions to global regulatory authorities.

This Package contains advanced, out-of-the-box EDMS functionality including the following features:

  • Audit Trails
  • Reporting
  • Workflows
  • Messaging
  • Auto-Rendering
  • Version Control
  • Lifecycle Management
  • Full-text Searching
  • Role-based Security/Permissions 
  • 21 CFR Part 11 Electronic Signatures

The R&D Submission Documents Package also contains the following pre-defined configurations and professional services:

DocCompliance configuration, designed specifically for R&D use, based on business fundamentals following the DIA EDM reference model and CTD standards

  • 14 pre-defined document types, including the following:

          - CMC - Drug Product
          - CMC - Drug Substance
          - Specifications
          - Clinical
          - Nonclinical

  1. Regional (i.e., Module 1)
  2. Safety
  3. Submission Archive
  4. Product Information
  • 7 pre-defined workflows to ensure best practice content progression and management
  • 4 pre-defined collection types: CSR, CTMF, CTD & General Collections
  • A taxonomy (cabinet / folder structure) matching the common CTD structure
  • Supporting configuration for R&D Submissions

Documentation

  • Design Document detailing the pre-defined configuration
  • Client-specific Pick list values document
  • Validation Pack: IQ, PQ, Functional Specification, Design Specification, and Trace Matrix (OQ not required because this Package contains a pre-defined configuration)
  • End-user training course (PDF Guide) plus 90-days access to QUMAS' Computer-based Training (CBT) Series
  • System Access Plan

Professional Services including full Package installation, delivery of End-user training and Train-the-Trainer training

A Professional Services Review once the system has been in production use for at least 3 months

For more information download the QUMAS R&D Submission Documents Package Datasheet.