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SOP-006-SoftwareValidation.md

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sop_id SOP-006
title Software Validation (QMS Tools)
revision R05
revision_date 2026-05-04
status Published
owner_role qa_lead
approver_role management_representative
related_issue #2

1. Purpose

Define risk-based validation and revalidation of software used in the QMS.

2. Scope

Applies to software tools that create, modify, approve, or retain quality records and compliance evidence.

3. Inputs

  • Tool purpose and intended QMS use
  • Risk assessment (impact to record integrity, product quality, and compliance decisions)
  • User requirements and acceptance criteria

4. Outputs

  • Validation record with scope, tests, results, and approval
  • Revalidation record after significant tool changes

5. Roles and Responsibilities

Role Responsibilities
QA Lead Owns validation planning, evidence completeness, and approval routing.
Tool Administrator Configures tool and executes test protocol steps.
Process Owner Confirms validated behavior supports intended process use.
Management Representative Approves validation for high-criticality tools.

6. Procedure

6.1 Tool Inventory and Criticality

  1. Maintain QMS tool inventory in matrices/qms_tooling_inventory.yml.
  2. Classify each tool criticality (high, medium, low) based on impact to record integrity, product quality, and compliance decisions.

6.2 Validation Planning

  1. Define intended use and user requirements.
  2. Define validation strategy proportional to risk and complexity.
  3. Define objective acceptance criteria for each requirement.
  4. Define traceability from intended use and requirements to planned test coverage and expected evidence.

6.3 Validation Execution

  1. Execute test cases and capture evidence (screenshots, logs, exported artifacts).
  2. Record deviations and assess impact.
  3. Maintain traceability between defined requirements, executed tests, and captured evidence.
  4. Resolve critical deviations before tool release for QMS use.

6.4 Approval and Release

  1. QA Lead reviews validation completeness.
  2. Management Representative approval is required for high-criticality tools.
  3. Tool status in inventory is updated to validated only after approval.

6.5 Validated State Maintenance and Revalidation Triggers

Maintain the validated state throughout tool use by monitoring for internal or vendor changes that could affect intended use, risk, or evidence integrity.

Revalidation is required when:

  1. Tool vendor introduces major functional/security changes.
  2. Internal workflows/automation logic changes quality-critical behavior.
  3. New intended QMS use is introduced.

7. Required Records

  • Validation plan and protocol
  • Test results and deviation log
  • Validation summary and approval record

8. Traceability

Standard Clause Control in this SOP
ISO 13485:2016 4.1.6 Defines validation/revalidation controls for QMS software applications.

9. Related Controlled Documents

  • SOP-001 Document and Record Control
  • SOP-005 QMS Governance

10. Revision History

Revision Revision Date Change Summary
R00 2026-03-02 Initial full release.
R01 2026-03-08 Updated governance cross-reference after the Quality Manual was split out of SOP-005.
R02 2026-03-18 Removed top-table standards clause metadata; normative references remain in the Traceability section.
R03 2026-03-25 Generalized the purpose statement, added product-quality criticality language, required requirement-to-test traceability, and defined validated-state maintenance expectations.
R04 2026-04-27 Renamed YAML metadata field effective_date to revision_date to align controlled-document metadata with the tag-based publication model. The effective date is derived from the published QMS release tag rather than from the document front matter.
R05 2026-05-04 Standardize standards citations to specific versions.