Validation Package

The Validation Package dashboard provides tools for generating, managing, and tracking compliance documentation required for computer system validation (CSV). It supports the complete validation lifecycle from planning through execution and release.

What You Can Do

• Generate individual validation documents (VMP, URS, IQ/OQ/PQ, and more)
• Generate a complete validation package with all documents at once
• Track validation execution status with test case management
• Execute manual and automated IQ/OQ/PQ test protocols
• Track deviations and corrective actions from test execution
• Monitor GAMP 5 and ISO 27001 compliance status
• Manage system release logs with validation impact assessment
• Export compliance evidence packages

Accessing the Validation Package

1. Navigate to Admin in the sidebar.
2. Select the Validation Package tab.

The dashboard loads with an overview of all validation document types, their generation status, validation execution metrics, and compliance management tools.

Dashboard Overview

Validation Status Banner

At the top of the dashboard, a status banner shows the current validation state:

Status	Meaning
Passed	All tests executed and passed with 100% pass rate
In Progress	Some tests have been executed but not all
At Risk	Failed tests or critical deviations exist
Not Started	No tests have been executed yet

The banner also displays key metrics:

• Total Tests
• Executed count
• Passed count
• Failed count
• Pass Rate (percentage)
• Open Deviations count

A progress bar visually represents the ratio of passed, failed, and pending tests.

Document Type Cards

The dashboard displays cards for each validation document type:

Document Type	Description
Validation Master Plan (VMP)	Master plan defining validation strategy, approach, and activities
User Requirements Specification (URS)	Specification of functional, non-functional, and regulatory requirements
Vendor Qualification (VQ)	Questionnaire for vendor qualification and compliance assessment
Validation Summary Report (VSR)	Summary report of validation activities and test results
IQ/OQ/PQ Protocols	Installation, Operational, and Performance Qualification protocols
Traceability Matrix	Matrix mapping requirements to test cases for coverage verification
System Overview	High-level system description and architecture documentation
Configuration Specification	Detailed configuration specifications and settings

Each card shows:

• Document name and description
• Generation status badge (Generated or Not Generated)
• Last generation date (if previously generated)
• Generate button to create or regenerate the document
• Download button (if already generated) to view/download the latest version

Generating Documents

Individual Document Generation

1. Find the document type card on the dashboard.
2. Click Generate.
3. The system navigates to the document-specific generator page.
4. Configure any generation options specific to that document type.
5. Click Generate to create the document.
6. Once complete, the document appears in the Recent Packages table.

Full Package Generation

1. Click Generate Full Package in the top-right corner of the dashboard.
2. The system generates all validation documents as a single package.
3. Monitor progress on the generation page.
4. Once complete, all documents are available as a unified package.

Validation Execution and Testing

The dashboard provides four testing tools:

Test Cases

Define and manage IQ/OQ/PQ test cases with requirements traceability.

1. Click Test Cases in the Validation Execution section.
2. Create test cases with descriptions, expected results, and linked requirements.
3. Organize test cases by qualification type (IQ, OQ, PQ).

Manual Tests

Step through test cases manually and record results with evidence.

1. Click Manual Tests in the Validation Execution section.
2. Select a test case to execute.
3. Follow the test steps and record actual results.
4. Attach evidence (screenshots, logs) as needed.
5. Mark each test step as passed or failed.

Automated Tests

Run automated IQ/OQ/PQ tests with LLM-powered analysis.

1. Click Automated Tests in the Validation Execution section.
2. Select test cases to run automatically.
3. The system executes tests and uses AI analysis to evaluate results.
4. Review automated test results and evidence.

Deviations and CAPA

Track deviations discovered during testing and manage corrective actions.

1. Click Deviations & CAPA in the Validation Execution section.
2. View open deviations with severity classifications.
3. Perform root cause analysis.
4. Create and track corrective and preventive actions.

Note

Deviations with “Critical” severity will change the overall validation status to “At Risk” regardless of test pass rate.

Compliance and Release Management

GAMP 5 Compliance

View the system’s GAMP 5 Category 4 classification, lifecycle phases, and validation status.

1. Click GAMP 5 Compliance in the Compliance section.
2. Review the classification details and lifecycle phase status.

ISO 27001 Compliance

Track ISO 27001 Annex A controls, identify compliance gaps, and review security measures.

1. Click ISO 27001 Compliance in the Compliance section.
2. Review control status by domain.
3. Identify and address compliance gaps.

Release Log

Create and manage system release logs with version tracking and validation impact assessment.

1. Click Release Log in the Compliance section.
2. Create new release entries with version numbers and descriptions.
3. Document validation impact for each release.
4. Track release history chronologically.

Recent Packages Table

The bottom of the dashboard displays a table of recently generated packages:

Column	Description
Package Type	The type of validation document
Version	Version number of the package
Status	Completed, Processing, Failed, or Pending
Artifacts	Number of generated artifacts in the package
Created	Generation date
Actions	View details, Export compliance evidence

Exporting Compliance Evidence

Click Export on a package row to download a ZIP file containing compliance evidence in CSV format. This is useful for regulatory submissions and audits.

Permissions

Action	Required Permission
View validation dashboard	Admin role
Generate validation documents	Admin role
Execute tests	Admin role
Manage deviations	Admin role
Export compliance evidence	Admin role

Tip

Generate validation documents after significant system changes or before regulatory audits. Keep the validation package up to date by regenerating documents when requirements change or new features are deployed.