What is a biohq in a biotech organization and which functions typically sit unde

BioHQ is a centralized operating hub that governs quality, biosafety, compliance, data integrity, and vendor oversight across research and manufacturing. It orchestrates GxP-aligned quality systems (documents, training, deviations/CAPA, change control), biosafety programs (risk assessments, facility and PPE controls, incident response), regulated data and records (Part 11-compliant electronic systems), and third-party management (audits, quality agreements). In maturing organizations, BioHQ also coordinates risk management, inspection readiness, and cross-functional metrics. Core outcomes are consistent product quality, safe operations, and defensible compliance. Practically, BioHQ integrates site functions (labs, pilot/manufacturing, clinical operations) under a harmonized governance model informed by ICH Q10’s Pharmaceutical Quality System and biosafety frameworks. It sets policy, enables risk-based procedures, and ensures evidence of control—without paralyzing innovation. Digital infrastructure (ELN/LIMS/QMS) is governed for data integrity (ALCOA+) and access controls, while biosafety is kept current via periodic risk reviews. BioHQ’s remit scales with lifecycle: preclinical (GLP-like rigor), clinical supply (GMP), and commercial readiness. Key Takeaway: BioHQ centralizes quality, biosafety, data, and vendor governance to deliver safe, compliant, and scalable biotech operations.