Feature validation

Validation process:

1. Overview

The Validation Document ensures that all Unifize platform features and releases operate as intended, comply with regulatory standards (e.g., QMS/DMS), and maintain predictable behavior.

It is updated in alignment with feature enhancements, defect fixes, and scheduled releases to provide an auditable record of validation activities.

2. Types of Validation Documents

Feature Validation Report

Validates functionality, compliance, and stability of an individual platform feature. Maintains a complete change history of that feature.

Every time a feature receives an enhancement or defect fix.

Feature Overview, Installation Qualification (Environment & Version Details, Prerequisite Confirmations), Operational Qualification (Scope, Test Cases & Results), Feature Limitations, Impact Assessment (Impact Summary, Risk Analysis, Risk Register), Change Log.

Updated before release for major enhancements/critical defects (≥7 days prior). Updated at release for minor defects/low-impact updates.

Release Validation Report

Validates all features included in a weekly release, including cross-testing between features. Centralizes all changes for the release in one document.

Weekly (aligned with release schedule).

Release Overview (features covered, impacted modules), Cross-Feature Testing Scope, Test Cases & Results, Impact Assessment, Risk Analysis, Consolidated Release Change Log.

Published on release day.

Monthly Validation Report

Summarizes all validated features and releases in the month. Provides a cumulative view of testing and changes.

Monthly.

Monthly Overview, Cross-Release Testing, Consolidated Monthly Change Log, Residual Risk Summary.

Published at month-end.

3. Documentation Standards

  • Source of Truth:

    • Test Cases – Stored in Testomat with unique Test Case IDs, linked in the Validation Document.

    • Risk Analysis – Maintained in Notion risk register with unique Risk IDs, linked in the Validation Document.

    • Change Logs – Managed in Shortcut with Shortcut IDs, linked internally in the document.

    • Feature IDs – Derived from the internal Feature Database in Notion and hyperlinked.

  • Internal vs. External: Shortcut and Testomat links remain internal; customer-facing documents contain reference IDs but no direct system links.

  • Version Control: Each document includes the feature ID/release ID, server version, and date of validation.

4. Update Process

  • Feature Validation Report:

    • High Impact (major enhancements, critical defects) → Update 7 days before deployment.

    • Low/Moderate Impact (minor defects, small UI/UX tweaks) → Update on release day.

  • Release Validation Report: Finalized on release day, covering all included features and cross-testing results.

  • Monthly Validation Report: Compiled at the end of each month, summarizing all validation activities.

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