{"product_id":"ich-e6r3-kit-01-quality-system-foundations","title":"E6(R3) Sponsor Kit 01 — Quality System Foundations","description":"\u003cp\u003eThe procedures everything else hangs off: document control, risk, and who is qualified to do what.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e3 procedures, 12 records.\u003c\/strong\u003e E6(R3) wants a quality system that is proportionate and risk-based (3.10), critical-to-quality factors identified rather than assumed (3.1.2), and appropriately qualified people for the work they are given (3.4).\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eProcedure register, drafting and approval checklist, periodic review\u003c\/li\u003e\n\u003cli\u003eTrial risk register and critical-to-quality worksheet\u003c\/li\u003e\n\u003cli\u003eQualification map, training records, medical cover arrangement\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":47734516482219,"sku":"KA-TK-E6R3-K01","price":1095.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/5243\/9723\/files\/ich-e6r3-kit-01-quality-system-foundations.jpg?v=1788306686","url":"https:\/\/www.kaclinical.com\/products\/ich-e6r3-kit-01-quality-system-foundations","provider":"KA Clinical","version":"1.0","type":"link"}