Modern Document Management for Pharma
A comprehensive solution for pharmaceutical document management that replaces an aging Documentum system with a modern, compliant alternative fully integrated with webTraining.
Key Challenges
Aging System
Existing Documentum platform showed its age in functionality and resource usage.
Complex Requirements
Need for pharma-specific processes and complete user requirement coverage.
Global Accessibility
Multi-language, multi-site support needed across various devices.
Regulatory Compliance
Must meet 21 CFR Part 11 and ALCOA standards.
Functional Requirements
User Experience
- Modern, intuitive interface
- Multi-device accessibility
- Guided workflows
Document Types
- SOPs & Attachments
- Master Batch Records
- Specifications & Methods
- Validation & Projects
Portal Features
- Open access for officialized docs
- Specialized tools for editors
- Controlled approval process
Compliance & Integration
Regulatory Compliance
Fully validated system meeting 21 CFR Part 11 requirements and ALCOA principles for data integrity.
webTraining Integration
Seamless connection with existing Learning Management System for complete document lifecycle.
Infrastructure
Solid yet lightweight platform, shareable with the webTraining LMS already in use.
Solution Benefits
User Satisfaction
Intuitive interface requiring minimal training
Regulatory Readiness
Prepared for rigorous inspection visits
Multi-Plant Support
Unlimited plants with autonomous management
Complete Document Coverage
All document types with customizable workflows
Document Lifecycle Integration
1
Document Creation
Authors draft GxP documents in webDoc
2
Approval Process
Controlled workflow guides document approval
3
Training Creation
Automatic course generation in webTraining
4
Training Completion
Results return to webDoc for formalization
Implementation Timeline
Requirements Analysis
Detailed mapping of processes and needs
System Design
Architecture and interface planning
Development
Building core functionality and integrations
Validation & Deployment
Testing, compliance verification, and rollout
