SOP: Raw Data and Good Documentation Practice

This SOP: Raw Data and Good Documentation Practice defines how raw data must be recorded, handled, corrected, reviewed, and stored to meet GMP data integrity requirements. It ensures that all data generated during GMP activities is accurate, contemporaneous, traceable, legible, and compliant with ALCOA+ principles.
 
This SOP is professionally written and pre-filled (~95% complete), requiring only company-specific details before approval.
Developed by QA specialists with practical GMP experience, the template outlines correct documentation behaviour, rules for handwritten entries, significant digits and rounding, corrections, logbook use, data transfer, and reviewer responsibilities — including QP review where applicable.
 
Includes:
• Definition and handling of raw data
• Rules for recording observations in real time
• Requirements for handwritten entries and corrections
• Rounding rules & significant digits
• Logbook requirements
• Review and approval of raw data
• QP responsibilities during product release
 
Why it matters:
Raw data integrity is a critical focus area for inspectors. This SOP ensures your organisation follows consistent, compliant documentation practices that support traceability, accurate decision-making, and inspection readiness.