What core components define a biohq aligned quality system

A BioHQ-aligned quality system integrates policy, procedures, and digital controls to ensure consistent, compliant operations. Core components include: governance and management review (ICH Q10), document and record control, training and qualification, risk management (ICH Q9), deviation/incident management with CAPA, change control, audit and supplier management, and inspection readiness. For laboratories and manufacturing, it adds validation/qualification (facilities, equipment, computerized systems), data integrity controls (ALCOA+, audit trails), and lifecycle process control (e.g., CPV for manufacturing). Electronic systems must meet 21 CFR Part 11 for trustworthy electronic records and signatures, with periodic reviews. The biosafety program complements the QMS with risk assessments, engineering/administrative controls, PPE, and incident response consistent with BMBL/WHO guidance. Together, these ensure traceability, reproducibility, and defensible compliance across R&D to GMP. Key Takeaway: A BioHQ quality system unifies risk-based QMS, biosafety, and data integrity to consistently control processes and records across the biotech lifecycle.