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.
