This Software Validation Procedure complies with ISO 13485:2016, EU MDR 2017/745, FDA QMSR 21 CFR 820, and GAMP 5 principles. Delivered in editable Word format, it defines requirements for validating software used in production, quality systems, and device operation. Digital delivery within 24 business hours.
This procedure outlines software validation planning, requirements definition, testing, risk assessment, verification, validation reporting, and change control. It applies to QMS software, production software, and embedded device software. Delivered in editable Word format for easy customization. Consultancy support is available via email, Zoom, or on‑site visits. Full implementation or signed, approved procedures are available for an additional fee.