{"product_id":"good-documentation-practices","title":"Good Documentation Practices","description":"\u003cp\u003e\u003cstrong\u003eThe detailed, practical companion to your Data Integrity Policy\u003c\/strong\u003e — exact rules for how GXP documentation should be written, corrected, signed, and retained, down to date formats and correction procedures.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eWho it's for:\u003c\/strong\u003e All personnel — employees, contractors, consultants — who create, review, approve, or maintain GXP documentation.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eWhat's included:\u003c\/strong\u003e\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eALCOA+ documentation standards: date\/time formatting, decimal and rounding rules, signature requirements\u003c\/li\u003e\n\u003cli\u003e16-step General Requirements procedure covering everything from ink color to Table of Contents requirements\u003c\/li\u003e\n\u003cli\u003eCorrection procedures for physical and electronic records, including omitted-entry documentation\u003c\/li\u003e\n\u003cli\u003eCertified Copy creation process\u003c\/li\u003e\n\u003cli\u003eFull Definitions glossary (ALCOA+, Metadata, Raw Data, Static\/Dynamic Data, and more)\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eFormat:\u003c\/strong\u003e Fully editable Word document (.docx).\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eRegulatory alignment:\u003c\/strong\u003e Cites FDA retention requirements under 21 CFR §§ 211.68(b), 211.188, 211.194, and 212.60.\u003c\/p\u003e","brand":"FDA-SOPs","offers":[{"title":"Default Title","offer_id":52387132014897,"sku":null,"price":2500.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.fda-sops.com\/products\/good-documentation-practices","provider":"FDA-SOPs","version":"1.0","type":"link"}