Feature Overview

GENERAL FEATURES
100% Paperless
Intelligent Documentation
Data Driven
Agile Approach
Lifecycle Approach
100% Configurable
No Coding
Quality by Design Approach
Collaborate in Real Time
Controlled Environment
Standardised Business Process
Technology
Best of Breed Platform
Best of Breed Practices
Microsoft .NET Platform
Secure Socket Layer (SSL) Login
Secure Optimised Database
Easy Integration With Other Enterprise Applications
Import Data As Required
Full Enterprise Level Scalability
21 CFR Part 11 Controls in Place
Business Process Modelling
Dynamic Model Creation
Create Standardized Structure
Create Flexible Structure
Capture & Maintain Data & Relationships
Manufacturing Facility
Systems Lifecycle
Cloning of Models
Model and Replicate Entire Systems
Replicate Individual System Parts
Release System Parts as Needed
Define Structure From Documentation Perspective
Life Cycle Documentation
Define Document Templates
Workflows
Document Change Control
Requirements Management
Generation of Requirements
Requirement Management
Risk Management
Dynamic Requirements Traceability Matrix
Documents Based On Requirements Automatically Generated
Online Testing of Requirements
Documentation
Document Generation
Requirement Documents
Risk Management Documents
Design Documents
Traceability Documents
Test Documents & Protocols
Online Review
View Comments in Real Time
Online Approval
Auto-Generate Test Documents
Online Test Execution
Online Deviation Management
Auto-generate Reports
Retest Protocols
Team Collaboration on a Single Documents in Real Time
And much more…
Change Management
Dynamic Robust Change Management
Online Change Requests
Identify Impacts To All Other Life Cycle Documents
Clear View Of Potential Changes
Retest Protocols For Proposed Changes
Automated Change Execution
Automatically Update All Affected Document Sections
Streamlines Change Execution
Automates Change Execution
Leveraging / Standardisation
Standardised Business Processes
Standardise Templates
Standardise Models
Standardise Documents
Leverage Templates
Leverage Models
21 CFR Part 11
Closed System
Validated Compliance
Accurate and Complete Records
Records in Human Readable Form
Records Easily Retrieved
Access Controls
Secure, Computer-Generated, Time-Stamped Audit Trails
Rules Enforced Workflows
Electronic Signatures Bound to Electronic Records
Seamless Integrated Experience
Single User Sign-on
Multi-User System with Unlimited Roles and Permissions
Multi-Roles Control Panel
Admin Control Panel
User Control Panel
Unified Permission System
Security
Granular Privileges
Problem Notification
Secure Socket Layer (SSL) Login
Email Verification
Login "Strike" System
Email and Password Change Require Current Password
Support
Customer Ticket Support
Customer Phone Support
Customer Forum Support
Consultancy Services
Professional Services
STANDARD COMPLIANT
XHTML Complaint
Cross Browser Compatibility