Validation Hub

Real-time compliance & project management dashboard

100%

Healthy Portfolio - 17/17 projects on track

Last Updated

Just now

Critical

0% of portfolio

High

0% of portfolio

Medium

0% of portfolio

Low

0% of portfolio

GAMP-5

projects

Total Projects

0 active

In Progress

projects

Completed

projects

Insights 0

No insights available. Analyzing your data...

Projects by Status

GAMP Category Mix

Projects Created per Month

Deliverables Status (Total)

Status by GAMP (Stacked)

Team Workload

Industry Benchmarks

TEAM WORKLOAD

Your Average

4.2 proj/person

Industry Average

3.8 proj/person

10% above industry average - Consider workload distribution

AVG. VALIDATION TIME

Your Average

68 days

Industry Average

75 days

9% faster than industry - Excellent performance

Goal Tracking

Q4 2025: Complete 20 Projects

17/20

85% complete Est: Dec 15, 2025

CURRENT VELOCITY

2.3

proj/week

9.8

proj/month

1.5

needed/week

Quick Start

Create new validation project with auto-generated deliverables

Applications & Systems

Manage all GxP systems and their validation projects

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Validation Projects

Manage and track validation projects

Applications

Select an application to view projects

Select an Application

Choose an application from the left pane to view its validation projects

Project Deliverables

Manage validation documents and deliverables for each project

Search Project

Select Project

-- Select a Project --

Select a Project

Choose a project from the dropdown above to view its deliverables

Master Template Library

Comprehensive validation document templates across all SDLC phases

Total Templates

Approved

In Draft

Under Review

Search Templates

Filter by Phase

Filter by Status

Filter by Type

Requirements Management

Define GxP-compliant requirements, ensure traceability, and manage specifications per GAMP 5 guidelines

Applications

Select an application to manage requirements

Requirements & Specifications

Manage URS, FS, DS, and CS specifications with full traceability

Test Suite Management

Organize test cases, link requirements, track execution, and ensure comprehensive validation coverage

Applications

Select an application to manage test suites

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Requirements Traceability Matrix (RTM)

Comprehensive traceability from requirements through testing with full audit trail

Select Application

Search Project

Select Project

-- Select a Project --

S.No	URS ID	User Requirement	Functional Spec ID	Functional Spec Desc	Design Spec ID	Design Spec Desc	Config Spec ID	Config Spec Desc	Test Case ID	Test Case Title	Test Result	Test Type	Remarks	Status	Actions
No RTM Records Yet Select a project and click "Auto-Generate RTM" to create traceability records

Requirements Traceability Matrix

Establish complete traceability from user requirements through functional specifications, design, configuration, and test execution. Ensure 21 CFR Part 11 compliance with full audit trail.

What RTM Provides:

Complete bidirectional traceability
Test coverage verification
Gap analysis and missing links
Approval workflow with e-signatures
Full audit trail for compliance

Validation Hub

GAMP-5

Total Projects

In Progress

Completed

Projects Requiring Attention

Active Alerts

Dashboard Filters

Projects by Status

GAMP Category Mix

Projects Created per Month

Deliverables Status (Total)

Status by GAMP (Stacked)

Team Workload

Industry Benchmarks

Goal Tracking

Quick Start

Applications & Systems

Validation Projects

Applications

Project Deliverables

Master Template Library

Notifications

Requirements Management

Applications

Requirements & Specifications

Test Suite Management

Applications

Requirements Traceability Matrix (RTM)

Agile Sprint Management

Validation Hub

GAMP-5

Total Projects

In Progress

Completed

Projects Requiring Attention

Active Alerts

Dashboard Filters

Projects by Status

GAMP Category Mix

Projects Created per Month

Deliverables Status (Total)

Status by GAMP (Stacked)

Team Workload

Industry Benchmarks

Goal Tracking Set Goals

Quick Start

Applications & Systems

Validation Projects

Applications

Project Deliverables

Master Template Library

Create Master Template

Template Information

Template Structure

Document Editor

Approval Workflow

Your Action Required

Version History

Create New Version

Configure Approval Workflow

Notifications

Document Preview

Requirements Management

Applications

Requirements & Specifications

Test Suite Management

Applications

Requirements Traceability Matrix (RTM)

Agile Sprint Management

Remove Deliverable

Add New Deliverable

New Validation Project

Step 1: Project Information

Step 2: GAMP 5 Category Assessment

Step 3: Methodology & Timeline

Add User Requirement (URS)

Create New Requirement Type

Create New Category

Requirement Details

Audit Trail

Linked Test Cases (Traceability)

Link Test Case to Requirement

Create New Sprint

Edit Sprint

Close Sprint

Create Test Suite

Add Test Case

Execute Test Case

New Application/System

Version Management

New Version

Goal Tracking