Gamp 5 Category 3 -

Standard laboratory instrument software (e.g., a simple pH meter or balance software).

| 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 | gamp 5 category 3

Because Category 3 software is standardized and used by a wide market, the inherent risk associated with "bugs" in the core code is generally considered lower than Category 5 (Custom) or Category 4 (Configured) systems. Consequently, the validation burden is lighter, allowing companies to leverage the vendor's own testing. The Validation Lifecycle for Category 3 Standard laboratory instrument software (e

You use built-in tools to change the workflow . For example, if you configure a Laboratory Information Management System (LIMS) to follow a specific multi-step approval routing, it has graduated to Category 4. The Validation Lifecycle for Category 3 You use