Documents within the scope of GDocP include but are not limited to the following document types

• Training records provide evidence of skills necessary to perform tasks
• Process Documents, including SOPs (Standard Operating Procedures) and WIs (Work Instructions establish what and how things are supposed to be done
• Internal audit results provide evidence of compliance to a regulatory requirement
• Research and development trade studies provide rationale for design or post market surveillance
• Formulas and calculations are design artifacts
• Manufacturing batch records provide traceability
• Laboratory records provide traceability
• Verification and validation protocols and results provide the proof of meeting requirements and user needs
• Inspection records provide evidence of quality
• Calibration Records support claims that equipment was in proper working order when product measurements are made
• Service / Maintenance Records show actions were properly taken and the results have not affected ability to meet specifications

Scope

Essentially, any formal document type, especially documents that require approvals and/or handwritten entries fall within the scope of this document.

Everything is in scope from manufacturing batch records to equipment calibration records; training records to test scripts, plans, protocols and reports.