Gamp: Guide For Validation Of Automated Systems

The life cycle of an automated system under GAMP 5 typically follows a structured path often visualized as a "V-Model." This model links specifications on the left side with corresponding testing and verification activities on the right.

Verification and Testing: This phase includes various levels of testing, such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Each test is mapped back to the original specifications to ensure full coverage. gamp guide for validation of automated systems

| Category | Description | Validation Strategy | | :--- | :--- | :--- | | | Infrastructure Software (OS, Database engines, Network components). | Verify installation; managed by IT procedures. | | Category 3 | Non-Configured Products (Off-the-shelf software used "out of the box," e.g., MS Word, standard calculators). | Focus on User Requirements and "black box" testing. No code review needed. | | Category 4 | Configured Products (Off-the-shelf software configured for specific use, e.g., LIMS, SCADA, ERP). | Configure parameters; validate configuration and workflows. Most common category for lab/manufacturing systems. | | Category 5 | Custom Applications (Custom coded software). | Full lifecycle validation, including code review and unit testing. Highest risk and cost. | The life cycle of an automated system under

Decisions regarding validation should be based on sound scientific and engineering judgment, not just a checklist. | Category | Description | Validation Strategy |