perform-csv-assessment - Perform CSV Assessment with GAMP 5 Methodology
Perform Computer Systems Validation assessment following GAMP 5 methodology covering URS, risk assessment, IQ/OQ/PQ, traceability, and validation reporting.
Tags
Updated: 2026-06-30Capabilities
What this skill does
- Determine GAMP 5 software category
- Write User Requirements Specification
- Perform FMEA risk assessment
- Define validation plan
- Create IQ/OQ/PQ test protocols
- Build traceability matrix
- Write validation summary report
Inputs
- System description
- Intended use statement
- GxP regulatory context
- GAMP 5 software category
- Existing URS documentation
- Vendor documentation
- Previous validation documentation
Outputs
- User Requirements Specification document
- Risk assessment document
- Validation plan document
- IQ/OQ/PQ test protocols
- Traceability matrix document
- Validation summary report
Requirements
- File read, write, and edit permissions
- Bash execution environment
- Grep and Glob search tools
- GxP regulated environment context