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Data Integrity
Data Integrity
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$2,500.00 USD
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A complete, audit-ready Data Integrity and Record Retention Policy for GXP documentation — built around the ALCOA+ framework and covering GCP, GDP, GLP, GMP, and GVP requirements.
Who it's for: Virtual and lean pharmaceutical sponsors responsible for creating or maintaining GXP documentation governed by Health Authorities.
What's included:
- Purpose and Scope
- Responsibilities and Approvals (department sign-off table)
- Associated Documents and References — pairs with our Good Documentation Practices SOP (QA004)
- Definitions and Abbreviations (ALCOA+, GXP, electronic vs. physical records, and more)
- 11 governing Principles covering data integrity controls, risk-based data criticality, access control, and archival requirements
- Appendices section (template — add your company-specific forms)
- Version History log
Format: Fully editable Word document (.docx).
Regulatory alignment: ALCOA+ (Attributable, Legible, Contemporaneous, Original or Certified Copy, Accurate, Complete, Consistent, Enduring, Available); applicable across GCP, GDP, GLP, GMP, and GVP.