Software Validation Procedure - ISO 13485

ISO 13485:2016 QMS Template - Software Validation and Re-validation Procedure (QMS.4.1.6 - QP)

Enhance your Quality Management System with our ISO 13485:2016 compliant Software Validation and Re-validation Procedure template, expertly crafted by the professionals at Patient Guard. Our Medical Device Quality Assurance and Regulatory Affairs document templates are developed by experienced experts, ensuring they meet the specific requirements of each clause and section of the relevant standards or regulations.

Why Choose Our Template?

• Expertly Designed: Created by seasoned Quality Assurance and Regulatory Affairs specialists, our templates ensure full compliance with ISO 13485:2016 standards.
• Easy Customization: Fully editable in Microsoft Word, our templates allow you complete control to modify and tailor them to your specific business needs and branding.
• Compliance Assurance: Utilizing our template helps you maintain effective software validation and re-validation procedures, demonstrating robust quality management as required by ISO 13485:2016.

What is Software Validation and Re-validation?

Software validation ensures that the software product satisfies its intended use and meets the requirements of the end-users. This process verifies that any calculations performed by the software produce consistent, accurate, and reliable results. Re-validation is integral if the software has been modified or used for product validation, QC checks, equipment calibration, etc.

How Does the Template Help with ISO 13485 Compliance?

This template aids your compliance with Clause 4.1.6, which requires companies to document procedures and records for the validation of computer software used within the QMS. It specifies that software should be validated before its first use, and re-validation is required if any changes are made.

Do You Require Any Supporting Documents?

Additional templates that may be of interest include:

• QMS.4.1.6.1 - QR - Master Software List
• QMS.4.1.6.2 - QR - Software Acceptance Testing Template

Why Patient Guard?

Stay ahead with Patient Guard’s consultancy services, offering a cost-effective solution for all your Quality Management System needs. For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.

Visit our blog for updates on regulatory and quality assurance news, and take the next step in enhancing your Quality Management System with Patient Guard.

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