Case Study: Standard BioTools achieves harmonized, automated quality management and faster processing with ComplianceQuest's AI-powered EQMS

Next-Gen Medical Technology Provider Harmonizes Quality Management with ComplianceQuest’s AI-powered EQMS

Standard BioTools, a San Francisco–based next‑generation medical technology provider, faced fragmented quality systems across three sites—manual, paper‑based processes in some locations and an outdated EQMS in others—making harmonized ISO 13485 compliance and efficient, integrated quality management impossible. Seeking a Salesforce‑native, customizable solution, Standard BioTools selected ComplianceQuest’s AI‑powered EQMS and purchased nearly 600 licenses to centralize quality across sites.

ComplianceQuest implemented a configurable EQMS suite (Audit, CAPA, Document, Change Management, Supplier, Inspection, Training, etc.), automating and harmonizing quality processes enterprise‑wide. The results included cutting document approval from three weeks to 4–5 days, halving complaint handling time, reducing document processing from 10 clicks to 3, fully automating inspections, shifting document controllers’ time from ~80% to 20% on admin tasks, and shrinking SOPs from about 80 to 20—outcomes ComplianceQuest enabled while supporting remote operations during COVID and earning high praise from auditors.

Standard BioTools

Ben Eder

Senior Director