Good Documentation Practices

The detailed, practical companion to your Data Integrity Policy — exact rules for how GXP documentation should be written, corrected, signed, and retained, down to date formats and correction procedures.

Who it's for: All personnel — employees, contractors, consultants — who create, review, approve, or maintain GXP documentation.

What's included:

• ALCOA+ documentation standards: date/time formatting, decimal and rounding rules, signature requirements
• 16-step General Requirements procedure covering everything from ink color to Table of Contents requirements
• Correction procedures for physical and electronic records, including omitted-entry documentation
• Certified Copy creation process
• Full Definitions glossary (ALCOA+, Metadata, Raw Data, Static/Dynamic Data, and more)

Format: Fully editable Word document (.docx).

Regulatory alignment: Cites FDA retention requirements under 21 CFR §§ 211.68(b), 211.188, 211.194, and 212.60.