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.

Auto-Generated Validation — No Manual IQ/OQ/PQ Needed

Traditional computer system validation requires months of manual document authoring for VMP, URS, IQ, OQ, PQ protocols, and traceability matrices. InnoQualis auto-generates all of these based on your workspace configuration, industry selection, and compliance framework. Select Generate Full Package and receive a complete, regulation-ready validation package in minutes — not months. Zero consultant fees, zero manual protocol writing.

Open the Validation Package dashboard

1. On the left sidebar, select Admin.
2. In the admin sidebar under Compliance, select Validation Package.

The dashboard loads with a status banner, document type cards, validation execution tools, compliance management sections, and a recent packages table.

Understand the validation status banner

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

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 total tests, executed count, passed count, failed count, pass rate, and open deviations count. A progress bar visually represents the ratio of passed, failed, and pending tests.

Document types

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 the document name, description, generation status badge, last generation date (if applicable), a Generate button, and a Download button (if already generated).

Generate a single validation document

1. On the dashboard, find the document type card you want to generate.
2. Select Generate.
3. On the document-specific generator page, configure any generation options.
4. Select Generate to create the document.
5. Once complete, the document appears in the Recent Packages table at the bottom of the dashboard.

Generate a full validation package

1. On the dashboard, select Generate Full Package in the top-right corner.
2. Monitor progress on the generation page.
3. Once complete, all documents are available as a unified package.

Manage test cases

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

Execute manual tests

1. On the dashboard, in the Validation Execution section, select Manual Tests.
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.

Run automated tests

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

Track deviations and CAPA from testing

1. On the dashboard, in the Validation Execution section, select Deviations & CAPA.
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 change the overall validation status to “At Risk” regardless of test pass rate.

Review GAMP 5 compliance

1. On the dashboard, in the Compliance section, select GAMP 5 Compliance.
2. Review the system’s GAMP 5 Category 4 classification, lifecycle phases, and validation status.

Review ISO 27001 compliance

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

Manage the release log

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

View recent packages

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

Export compliance evidence

1. In the Recent Packages table, on the package row, select Export.
2. A ZIP file containing compliance evidence in CSV format downloads to your computer.

Use exported evidence 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. Regenerate documents when requirements change or new features are deployed.

Practical example: Prepare a complete validation package for an FDA pre-approval inspection

Your company has an FDA pre-approval inspection scheduled and needs to demonstrate that the eQMS is validated per 21 CFR Part 11 and GAMP 5 guidelines.

1. Open Admin > Compliance > Validation Package.
2. Review the status banner. If it shows “Not Started”, begin by generating the full package.
3. Select Generate Full Package in the top-right corner. The system auto-generates:
   • Validation Master Plan (VMP) — populated with your workspace’s industry, compliance frameworks, and validation strategy.
   • User Requirements Specification (URS) — derived from your configured workflows, form templates, and system capabilities.
   • IQ/OQ/PQ Protocols — test cases auto-generated from your system configuration (e.g., verifying that approval workflows enforce the correct number of signatures, that audit trails capture all required fields).
   • Traceability Matrix — automatically linking each URS requirement to its corresponding test cases.
4. Navigate to Test Cases under Validation Execution. Review the auto-generated test cases and add any site-specific tests.
5. Select Automated Tests and run the full suite. The system executes tests against your live configuration and uses AI analysis to evaluate results.
6. For any failed tests, navigate to Deviations & CAPA to document the finding and corrective action.
7. Once all tests pass, review GAMP 5 Compliance to confirm Category 4 classification status.
8. In the Recent Packages table, select Export to download a ZIP containing all compliance evidence.

Present the exported package to the FDA inspector. It contains a complete validation lifecycle — from planning through execution and release — with tamper-evident audit trails for every action. What traditionally takes 3-6 months of manual effort is generated and executed in a single session.