Our Commissioning, Qualification and Validation (CQV) services follow a science- and risk-based framework, with the objective of ensuring efficient and audit-ready facilities and systems.
The CQV lifecycle focuses on Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs), supported by a structured System Risk Assessment (SRA) to identify Critical Design Elements (CDEs) and to distinguish critical systems from non-critical utilities.
Commissioning and qualification activities are integrated, so that Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) data can be used during formal qualification. Verification is undertaken through Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols.
This integrated approach supports systematic documentation and verification of production assets, establishing their suitability for their intended manufacturing purpose and their compliance with applicable requirements.
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