Validation of Software Used in Quality Management System
[ISO 13485:2016 Clause Clause 4.1.6]
The organization shall document procedures for the validation of the application of computer software used in the quality management system. Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application.
If your company uses any software to manage or support Quality Management System processes (like document control, training, calibration, complaint handling, CAPA, or production records), you must validate that this software works as intended for its purpose and that it maintains data integrity, accuracy, and reliability.
This is not limited to medical device software, but software that helps run the Quality Management System.
Key Elements of Software Validation
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Define Intended Use: What process is supported? What is the risk if the software fails?
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Risk Assessment: Identify risks to product quality or patient safety due to software errors.
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Validation Plan: Define scope, responsibilities, test strategy, acceptance criteria, and documentation plan.
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System Requirements Specification (SRS): Describe what the software is expected to do.
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Testing / Verification:
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Functional tests (does it work as expected?)
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Data integrity checks
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Security and access control tests
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Backup/recovery verification
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Validation Report: Summarize test results and conclude whether the software is fit for intended use.
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Change Control: Revalidate after updates, configuration changes, or migrations.
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Record Retention: Keep validation records for audits
INTERNAL AUDIT TOOL
Frequently Asked Questions
When should Quality management system software be validated?
- Before initial use of the software in the Quality management system.
- After significant changes to the software, configuration, or environment (e.g., version upgrade, database migration).
- Periodically reviewed as part of change control or internal audit to confirm it remains valid and functional.
Is commercial off-the-shelf (COTS) software exempt from validation?
No. Even off-the-shelf or cloud-based quality management system software must be validated for its intended use within your organization.
You don’t need to re-test the vendor’s internal validation but you must verify and document that:
- The configuration meets your QMS needs.
- Key functions work correctly in your environment.
- The risk of failure is assessed and mitigated.
What type of software needs validation under ISO 13485 Clause 4.1.6?
Any software that is used within the Quality Management System and affects product quality, regulatory compliance, or data integrity must be validated.
Examples include:
- Document control software
- CAPA/complaint management tools
- Training record systems
- Calibration or maintenance tracking tools
- ERP or LIMS modules used for production or traceability
If software only provides administrative functions (e.g., email or Word processing), validation is not required.
What documents should be maintained as evidence of software validation?
A complete validation file typically includes:
- Validation Plan-scope, responsibilities, and acceptance criteria.
- Risk Assessment impact of failure on product or process.
- User Requirement/Specification (URS).
- Test Protocols and Results.
- Validation Summary Report – conclusion of fitness for use.
- Change Control Records – for future updates or re-validation.
These documents provide traceability and demonstrate compliance during audits.