Qualification and Validation
Qualification and Validation
Establishing Compliance, Consistency, and Confidence Across Your Operations
Qualification and validation are critical components of regulated product development, ensuring that equipment, systems, processes, and facilities perform consistently and meet defined quality standards. At Bionetwork Consulting, we provide comprehensive Qualification and Validation services to help pharmaceutical, biotech, and medical device companies meet global regulatory requirements and maintain product quality and safety throughout the lifecycle.
Our team brings deep expertise in GxP environments and supports your organization in designing, executing, and documenting qualification and validation activities that are inspection-ready, risk-based, and aligned with FDA, EMA, and ICH guidelines.
Our Services Include:
Equipment Qualification (IQ/OQ/PQ)
We perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing, laboratory, and IT equipment to ensure proper installation, functionality, and performance under real-world conditions.
Facility and Utility Qualification
Comprehensive qualification of cleanrooms, HVAC systems, water systems, and other critical utilities to ensure your facility is compliant with cGMP and capable of supporting regulated production or research activities.
Process Validation
Designing and executing process validation protocols to demonstrate that manufacturing processes are robust, repeatable, and capable of producing products that meet predefined quality specifications. We support all stages of process validation—from protocol development to final reporting.
