Which roles and raci structure are essential for a centralized biohq and how sho

A resilient BioHQ depends on clearly separated accountability with an explicit RACI. Typical roles include: (1) Quality (QA/QC): owns the Quality Manual, approves SOPs, oversees deviation/CAPA, and manages validation and change control governance. (2) Operations: owns day-to-day process execution, capacity planning, materials management, and laboratory/production scheduling. (3) Informatics/IT: owns system lifecycle (LIMS/ELN/MES/QMS), cybersecurity, data integrity controls, integrations, and backup/DR. (4) Data Governance: stewards master data (samples, materials, instruments, methods), metadata standards, and data catalog/taxonomy. (5) Compliance/Regulatory: ensures alignment to GLP/GMP/CLIA/CAP as applicable. (6) Process Owners: accountable for specific value streams (e.g., sequencing, assay validation, tech transfer). Build the RACI so QA is Accountable for quality decisions; Operations is Responsible for execution; Informatics is Responsible for system health and integrity; Data Governance is Accountable for definitions; Compliance is Consulted; end users are Informed. Enforce separation of duties for approvals and e-signatures. Use a cross-functional Change Advisory Board to triage risks and approve releases. Anchor the model to ICH Q10 (pharmaceutical quality system), ISO 9001’s process approach, and 21 CFR Part 11 for electronic records/signatures responsibilities. Key Takeaway: Define roles up-front, separate duties, and formalize a cross-functional CAB to keep quality, operations, and informatics aligned and compliant.