A Laboratory Information Management System (LIMS) orchestrates sample-centric operations: accessioning, chain-of-custody, workflow tracking, QC checkpoints, results aggregation, audit trails, and report generation. In genomics, essential capabilities include: robust barcode-driven tracking from receipt to archival; integration with sequencers and bioinformatics pipelines; versioned workflow management supporting change control; support for regulatory requirements (e.g., 21 CFR Part 11 e-signatures and audit trails for clinical labs); interoperability with EHRs via HL7/FHIR for report delivery; and granular role-based access to protect PHI. Configurability without excessive customization reduces validation burden. GxP-compliant cloud deployment can improve availability and scalability when appropriately qualified. Implementation success hinges on validation against user requirements, data migration strategy, and training. LIMS should complement—not replace—QMS, ELN, and pipeline orchestration tools; clear system boundaries reduce compliance risk.
Key Takeaway: Choose a LIMS that secures samples and data, integrates instruments and pipelines, and supports compliance, interoperability, and change control.