Which core functions should a biohq cover in a regulated biotech environment

In regulated biotech, a BioHQ should cover: 1) Sample and material lifecycle management (collection, accessioning, storage, chain-of-custody, disposition) aligned with biobanking and laboratory standards; 2) Experiment execution and documentation with compliant electronic records/signatures and complete audit trails; 3) Data integrity controls (ALCOA+) across instruments, manual entries, and computational outputs; 4) Master data and ontology management for consistent identifiers (samples, reagents, protocols, assays); 5) Validation state management (intended use risk, change control, periodic review) per GAMP/CSA; 6) Security and privacy (RBAC, least privilege, encryption, monitoring) mapped to NIST controls and HIPAA/GDPR where applicable; 7) Interoperability and FAIR metadata to enable reuse and exchange with external partners and regulators. Practically this means integrated LIMS/ELN capabilities, instrument connectivity, pipeline orchestration, and governance workflows (deviations, CAPA, training). Ensuring adherence to Part 11 and Annex 11 controls is essential for trustworthy electronic records and signatures, while ISO biobanking/laboratory standards provide operational quality guidance. Key Takeaway: BioHQ must span lifecycle, records/signatures, data integrity, validation, security, and interoperability to satisfy GxP expectations.