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
- Regional (i.e., Module 1)
- Safety
- Submission Archive
- 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.