COMMISSIONING, QUALIFICATION AND VALIDATION

Overview

We deliver risk-based qualification and validation programs aligned with ISPE Baseline Guides and GAMP5, ensuring traceability and compliance across systems and processes.

Core Deliverables

• Validation Master Plan (VMP)

• Equipment qualification (URS → DQ → IQ → OQ → PQ)

• Process validation (Stage 1–3 lifecycle)

• Cleaning validation strategy

• Computer System Validation (CSV)

• Continued Process Verification (CPV)

Regulatory Framework

• ISPE Baseline Guide Vol. 5

• GAMP5

• FDA Process Validation Guidance

• 21 CFR Part 11 / EU Annex 11

Advanced Capabilities

• Risk-based qualification (leveraging QRM)

• Data integrity embedded validation

• Digital validation lifecycle

Outcome

Robust, traceable validation programs ensuring system reliability and regulatory compliance.