CQV, CSV & CSA
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CQV, CSV & CSA
Our foundational service pillar covering the complete lifecycle of system and equipment validation in regulated environments.
Commissioning, Qualification & Validation (CQV)
Overview: End-to-end qualification services ensuring your equipment, facilities, and utilities are installed, operate, and perform as intended, meeting all regulatory requirements.
Commissioning, Qualification & Validation (CQV)
Overview: End-to-end qualification services ensuring your equipment, facilities, and utilities are installed, operate, and perform as intended, meeting all regulatory requirements.
Services Include:
- Design Qualification (DQ) — Verifying that proposed designs meet user requirements and regulatory standards before procurement.
- Installation Qualification (IQ) — Documented verification that equipment is installed correctly per manufacturer specifications and design intent.
- Operational Qualification (OQ) — Verifying that equipment operates correctly throughout all anticipated operating ranges.
- Performance Qualification (PQ) — Demonstrating that equipment consistently performs as intended under actual production conditions.
- Facility and Utility Qualification — Qualification of HVAC, water systems, compressed air, clean rooms, and other critical utilities.
- Re-qualification and Periodic Review — Scheduled re-qualification programs to maintain validated status throughout the system lifecycle.
Systems & Equipment We Qualify
Services Include:
- Automated Manufacturing Equipment and Process Lines
- Analytical Laboratory Instruments (HPLC, GC, UV, IR, Titrators, Particle Size Analyzers, DSC, TOC, ICP, Stability Chambers)
- Process Control Systems (DCS, DAS, BMS, SCADA)
- Packaging Lines and Filling Equipment
- Clean Room Systems and Environmental Monitoring Equipment
- IT/OT Infrastructure and Network Systems
Computer System Validation (CSV)
Comprehensive validation of computerized systems throughout their lifecycle, ensuring data integrity, regulatory compliance, and fitness for intended use. Our CSV approach is risk-based, following GAMP 5 methodology.
Services Include:
- Full Life Cycle Implementation with 21 CFR Part 11 and EU Annex 11 Compliance
- Validation of Chromatography Data Systems (CDS) — Empower, OpenLab, Chromeleon
- Standalone Laboratory Systems Validation (UV, IR, Titrators, TOC, ICP, DSC, Stability Chambers)
- Process Analytical Systems and PAT Validation
- Manufacturing Execution Systems (MES) Validation
- Enterprise Resource Planning (ERP) Validation — SAP, Odoo
- Clinical Trials Data Management Systems (EDC, CTMS)
- Pharma Software Validation — LIMS, QMS, DMS, LMS
- Data Integrity and Regulatory Gap Analysis
- Remediation for Computerized Systems
- Periodic Review of Computerized Systems
- Decommissioning of Computerized Systems
- Spreadsheet Validation
- IT/OT Infrastructure Qualification and Network Qualification
- Creation of CSV/CSA Procedures and Templates
Computer Software Assurance (CSA)
Services Include:
- CSA Risk Assessment and Implementation Planning — Identifying where to apply rigorous testing vs. leveraging vendor documentation and operational checks.
- Transition from CSV to CSA — Helping organizations evolve their validation approach to align with FDA’s CSA guidance while maintaining compliance.
- Unscripted Testing Strategies — Implementing exploratory and risk-based testing approaches that focus effort on high-risk, high-impact functionality.
- CSA Procedures, Templates, and SOPs — Creating your organization’s CSA framework documentation from scratch or adapting existing CSV procedures.
- Training on CSA Principles — Corporate, classroom, and online training to upskill your team on the CSA mindset and methodology.
- Creation of CSV/CSA Procedures and Templates
Why choose?
Latest equipment
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