Computer System Validation (CSV)

When a pharmaceutical company implements a new LIMS, MES, ERP module, electronic document management system or cloud application, one question

Modern pharmaceutical equipment increasingly depends on computerized and automated functions for process control, monitoring, alarms, recipes, electronic records, data acquisition,

Part 19 Initial qualification demonstrates that a facility, utility, equipment, or system is suitable for its defined intended use at

Requalification is the documented evaluation and, where justified, repeat verification of a previously qualified facility, utility, equipment, or system to

Part 17 Change control is one of the principal mechanisms for maintaining the qualified state after a facility, utility, equipment,

Part 16 The Qualification Summary Report (QSR) is the principal lifecycle-closure document used to consolidate, assess, and conclude whether qualification

Part 15 Deviation management is a critical component of qualification because qualification testing is specifically intended to determine whether a

Part 13 The protocol converts the qualification strategy into executable evidence: Requirement → Risk → Test Objective → Test Method

Part 12 URS → Risk Assessment → Design → FAT/SAT → IQ → OQ → PQ → SOP/Control → Final

Part 11 The lifecycle is: URS → Risk Assessment → DQ → FAT → SAT → IQ → OQ →