
Validation Excellence & Regulatory Compliance for Life Sciences

About FACTORIALS
FACTORIALS is a specialized validation and regulatory compliance consulting firm with over a decade of global experience serving pharmaceutical, biotechnology, medical device, and clinical research companies across Europe, North America, Asia, and Africa. We combine deep technical knowledge with real-world implementation expertise to help organizations achieve and sustain compliance with confidence. Our structured, risk-based approach ensures practical strategies that stand up to regulatory inspections while supporting long-term operational success.
We deliver comprehensive expertise spanning computerized systems, laboratory instruments, manufacturing facilities, and enterprise quality platforms. From system validation to quality management and audit readiness, FACTORIALS provides audit-ready documentation and strong traceability aligned with FDA, EU, ISO, and GAMP 5 standards. Our mission is to empower life sciences organizations to achieve regulatory excellence and data integrity through expert guidance and proven methodologies.
Our Services

Computer System Validation Services
Comprehensive CSV for GxP systems, SaaS/software validation (eQMS, ERP, etc.), equipment/HVAC/process validation, CQV, FAT/SAT/UAT, and complete validation lifecycle documentation aligned with GAMP 5 standards.

Quality & Compliance Solutions
End-to-end QMS implementation, SOP development, CAPA management, change control, audit management, vendor qualification, and regulatory compliance support including 21 CFR Part 11 and data integrity requirements.

Risk, Audit & Training Services
Risk management services including FMEA and impact analysis, comprehensive audit preparation, inspection readiness programs, and specialized training for validation and regulatory compliance teams.