{"product_id":"data-integrity","title":"Data Integrity","description":"\u003cp\u003e\u003cstrong\u003eA complete, audit-ready Data Integrity and Record Retention Policy for GXP documentation\u003c\/strong\u003e — built around the ALCOA+ framework and covering GCP, GDP, GLP, GMP, and GVP requirements.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eWho it's for:\u003c\/strong\u003e Virtual and lean pharmaceutical sponsors responsible for creating or maintaining GXP documentation governed by Health Authorities.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eWhat's included:\u003c\/strong\u003e\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003ePurpose and Scope\u003c\/li\u003e\n\u003cli\u003eResponsibilities and Approvals (department sign-off table)\u003c\/li\u003e\n\u003cli\u003eAssociated Documents and References — pairs with our Good Documentation Practices SOP (QA004)\u003c\/li\u003e\n\u003cli\u003eDefinitions and Abbreviations (ALCOA+, GXP, electronic vs. physical records, and more)\u003c\/li\u003e\n\u003cli\u003e11 governing Principles covering data integrity controls, risk-based data criticality, access control, and archival requirements\u003c\/li\u003e\n\u003cli\u003eAppendices section (template — add your company-specific forms)\u003c\/li\u003e\n\u003cli\u003eVersion History log\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 ALCOA+ (Attributable, Legible, Contemporaneous, Original or Certified Copy, Accurate, Complete, Consistent, Enduring, Available); applicable across GCP, GDP, GLP, GMP, and GVP.\u003c\/p\u003e","brand":"FDA-SOPs","offers":[{"title":"Default Title","offer_id":52387090497841,"sku":null,"price":2500.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.fda-sops.com\/products\/data-integrity","provider":"FDA-SOPs","version":"1.0","type":"link"}