{"product_id":"ich-e6r3-site-kit-01-quality-system-foundations","title":"E6(R3) Site Kit 01 — Quality System Foundations","description":"\u003cp\u003eThe quality system the other ten kits get issued under: document control, risk, and who is qualified to do what.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e3 procedures, 14 records.\u003c\/strong\u003e Answers 8 site-facing E6(R3) expectations, 3 of them new in R3.\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eDocument control and management of site SOPs\u003c\/li\u003e\n\u003cli\u003eQuality by design, risk management and critical-to-quality factors\u003c\/li\u003e\n\u003cli\u003eTraining and qualification records for site personnel\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eDo this kit first. Every other kit gets issued under its document control procedure, so approving them in the wrong order means re-issuing them afterwards.\u003c\/p\u003e\n\u003cp\u003eWord and Excel, editable, no macros. Individual Licence. These are templates, not an approved quality system.\u003c\/p\u003e","brand":"KA Clinical","offers":[{"title":"Default Title","offer_id":47762098749611,"sku":"KA-TK-E6R3-SITE-K01","price":369.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/5243\/9723\/files\/ich-e6r3-site-kit-01-quality-system-foundations.jpg?v=1788797746","url":"https:\/\/www.kaclinical.com\/products\/ich-e6r3-site-kit-01-quality-system-foundations","provider":"KA Clinical","version":"1.0","type":"link"}