OUR WORK
Experience in Action
Real challenges. Specialized expertise. Practical results. Explore selected projects from our team's professional experience across regulated life sciences, demonstrating the technical expertise and problem-solving capabilities behind QOVA Advisory.
Selected project experience from the professionals behind QOVA Advisory.
PHARMACEUTICALS / GxP / eQMS
Building a More Connected GxP Quality Management System
A full-lifecycle electronic quality management system implementation spanning six critical quality functions. Our team coordinated the integration of business requirements, historical quality records, and validated workflows.
The Challenge
Implementing an enterprise electronic quality management system requires multiple quality functions to operate through controlled, validated workflows. Business requirements, historical quality records, user testing, and documentation must be coordinated throughout implementation.
The Approach
Led the full-lifecycle implementation of Veeva Vault Quality Suite, including business requirements, workflow support, validation activities, user acceptance testing, historical quality-record migration, and system documentation. Collaborated with quality leadership on reporting, dashboards, and ongoing system management.
The Results
Implemented an integrated electronic quality management environment spanning deviations, complaints, change control, continuous improvement, audits, and supplier management, supported by migrated historical records and validation documentation.
LIFE SCIENCES / QUALITY OPERATIONS / CAPA
Strengthening Quality Investigations & CAPA Processes
Supporting structured nonconformance investigations, root cause analysis, CAPA development, and quality-event trending across regulated operations. We focus on corrective actions that address underlying systemic issues.
The Challenge
Quality events require thorough investigations, appropriate escalation, defensible root cause analysis, and corrective and preventive actions that address underlying issues.
The Approach
Provided quality oversight of nonconformances and CAPA responses, reviewed root cause investigations, supported escalation, analyzed quality trends, and trained process owners on developing robust corrective action plans.
The Results
Supported structured investigation and CAPA review practices, quality-event trending, and the development of technically supported responses for quality review and continuous improvement.
PHARMACEUTICALS & DIAGNOSTICS / VALIDATION / IQ/OQ/PQ
Supporting Qualification Across Regulated Manufacturing Operations
Executing equipment and computerized system qualification activities through controlled protocols, testing, and documented validation evidence. Ensuring technical review and system readiness across laboratory environments.
The Challenge
Regulated manufacturing and laboratory operations require documented evidence that equipment and computerized systems meet established requirements and perform as intended.
The Approach
Developed and executed validation and qualification documentation, including IQ/OQ/PQ protocols, requirements documentation, testing records, change control, and validation reports. Supported cross-functional quality review in regulated manufacturing and laboratory environments.
The Results
Generated documented qualification evidence supporting technical review, system readiness assessments, and controlled operations under applicable GMP/GxP requirements.