Quality Assurance & Validation
Our validation services ensure your processes, systems, and methods consistently produce results that meet predetermined specifications and quality attributes.
Validation Services
Process Validation
Comprehensive validation of manufacturing processes including process qualification, verification, and ongoing process verification.
Cleaning Validation
Development and execution of cleaning validation protocols to prevent cross-contamination and ensure product safety.
Computer Systems Validation (CSV)
Validation of computerized systems in alignment with PIC/S Annex 11 and 21 CFR Part 11 requirements.
Utilities Validation
HVAC, WFI, and utilities qualification to ensure systems meet design specifications and regulatory requirements.
Featured: Computer Systems Validation Services
Our specialized computer systems validation services ensure your digital systems meet regulatory requirements while maintaining operational efficiency. We provide:
Risk-based validation approaches that optimize resource utilization
Validation of ERP, LIMS, MES, and other critical systems
Data integrity assessments and remediation
Risked-Based Approaches
We implement risk-based quality assurance strategies that focus resources on critical areas while maintaining comprehensive compliance:
Risk Assessment
Systematic evaluation of potential risks to product quality
Mitigation Strategies
Development of controls to address identified risks
Monitoring Systems
Ongoing evaluation of control effectiveness
Continuous Improvement
Regular review and enhancement of quality systems
Environmental Monitoring
Our comprehensive environmental monitoring programs ensure manufacturing environments meet stringent cleanliness requirements:
-
Particulate and microbial monitoring program design
-
Cleanroom classification and qualification
-
Data trending and analysis
-
Contamination control strategy development
