{"product_id":"iso-13485-software-validation-kit","title":"ISO 13485 Software Validation Kit (QMS \u0026 Production Software)","description":"\u003cp\u003eValidate the software you use for quality records and production, in proportion to risk, as ISO 13485 clauses 4.1.6 and 7.5.6 require. Includes a production software protocol aligned with FDA's 2025 Computer Software Assurance guidance.\u003c\/p\u003e\u003ch2\u003eWhat's inside (6 files)\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eInventory and Planning:\u003c\/strong\u003e Software Inventory Register.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProtocols and Reports:\u003c\/strong\u003e Production Software Validation Protocol; Software Validation Report; Software Validation Summary; URS and Validation Protocol.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch2\u003eHow to use it\u003c\/h2\u003e\u003col\u003e\n\u003cli\u003eList every software application used in the QMS, production and measurement in the inventory.\u003c\/li\u003e\n\u003cli\u003eRate each one by risk and decide the level of assurance needed.\u003c\/li\u003e\n\u003cli\u003eWrite user requirements and the validation protocol; test high-risk functions with scripted tests.\u003c\/li\u003e\n\u003cli\u003eRecord results in the validation report and summary.\u003c\/li\u003e\n\u003cli\u003eRevalidate after upgrades, configuration changes or a change of intended use.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch2\u003eWho it's for\u003c\/h2\u003e\u003cp\u003eAny organization using software for quality records, production or measurement (eQMS, ERP, spreadsheets, test software).\u003c\/p\u003e\u003ch2\u003eGood to know\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003eInstant download. Editable Microsoft Office files, no macros.\u003c\/li\u003e\n\u003cli\u003eIncludes a Start Here guide with the contents and how to use them.\u003c\/li\u003e\n\u003cli\u003eLicensed for one organization, including its sites.\u003c\/li\u003e\n\u003cli\u003eTemplates don't reproduce ISO standards. You need your own licensed copies.\u003c\/li\u003e\n\u003cli\u003eAlso in the \u003ca href=\"\/products\/iso-13485-complete-qms-kit\"\u003eISO 13485 Complete QMS Kit\u003c\/a\u003e, which costs less than buying kits separately.\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":50498929197250,"sku":"ICC-13485-SW","price":59.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/iso-13485-software-validation-kit.png?v=1790150985","url":"https:\/\/isocloudconsulting.com\/products\/iso-13485-software-validation-kit","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}