Validation Planning and Execution

Service Description

Our approach aligns with ISO 13485, 21 CFR 820/QMSR, and GAMP 5 principles, focusing on risk-based, data-driven validation planning and execution. We assist clients in developing and maintaining robust validation frameworks covering: • Process Validation — IQ/OQ/PQ protocol authoring, execution, and documentation with traceability to design and risk controls. • Equipment Qualification — Commissioning, calibration, and lifecycle qualification of production and test equipment, including requalification and change-control assessments. • Software Validation — Validation of quality and manufacturing software systems (e.g., MES, EBHR, ERP, QMS, spreadsheets) per 21 CFR Part 11 and Annex 11 expectations.