CSV for GxP

Glossary of CSV and GxP Terms

Quick definitions for the most common CSV and GxP terms used throughout this section. Use the anchors to jump to a term.

ALCOA+

Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available.

A structured process that confirms a computerized system consistently performs its intended use and meets regulatory requirements.

ISPE’s Good Automated Manufacturing Practice guide, which provides a risk-based approach to CSV and validation lifecycle planning.

General term for Good Practice regulations (GMP, GDP, GCP, GLP, GVP) that protect product quality and patient safety.

Good Manufacturing Practice — governs manufacturing and quality control processes.

Good Distribution Practice — governs storage, transport, and distribution of regulated products.

Good Clinical Practice — governs clinical trials and protects patient safety and data integrity.

Good Laboratory Practice — governs non-clinical laboratory studies and data quality.

Good Pharmacovigilance Practice — governs safety monitoring and adverse event reporting.

Installation, Operational, and Performance Qualification — phases of testing to verify installation, functionality, and performance.

User Requirements Specification — defines what users need the system to do.

Functional Specification — describes how the system meets the URS requirements.

Design Specification — documents architecture, configuration, and technical design choices.

Requirements Traceability Matrix — links requirements to test evidence.

Validation Master Plan — outlines validation scope, responsibilities, and activities.

FDA regulation on electronic records and signatures in the United States.

EU guideline outlining expectations for computerized systems in GMP environments.

Strategy that focuses validation effort on functions with the highest impact on product quality and patient safety.