| Document | Purpose | Typical Owner | |----------|---------|--------------| | Validation Master Plan (VMP) | Overall validation strategy, roles, deliverables | Validation Lead | | User Requirements Specification (URS) | Business needs, regulatory constraints | Business Owner | | Functional Specification (FS) | Detailed functional mapping of configuration | System Analyst | | Configuration Specification (CS) | Exact parameter values, screen layouts, workflow definitions | Configuration Engineer | | CI (Configuration Item) Register | Traceability of each configurable element | Configuration Engineer | | IQ/OQ/PQ Protocols & Reports | Formal testing evidence | QA / Validation | | Supplier Qualification Report | Evidence of vendor competence | Procurement/QA | | SOPs (Operational, Backup, Security) | Day‑to‑day use & maintenance | Operations | | Change Control Log | Record of all post‑release changes | Change Control Board | | Periodic Review Report | Ongoing suitability assessment | QA | | Retirement Plan & Archive Verification | Secure data disposition | IT/Records Management |

The defining characteristic of Category 3 is that the software is used . While you might enter specific data into the system (such as user names or local time zones), you do not alter the software’s underlying workflow, business logic, or functional behavior to meet your specific business processes. Common Examples: