Hi, I’m Ranee Moor, Chief Operating Officer of Quality Systems & Technology (QST). My career began in the laboratory (Environmental, Research, and Analytical). From there, I moved into Regulatory Affairs, where I learned the full drug development lifecycle and supported IND and NDA submissions. I then transitioned into the CRO world, deepening my expertise in GCP and gaining hands-on exposure to 21 CFR Part 11 and Computer System Validation. Consulting followed, giving me the opportunity to lead diverse, cross-functional projects and strengthen my end-to-end understanding of clinical quality and operations.

Along the way, I’ve provided comprehensive Clinical QA support (audit/inspection readiness, SOP and WI frameworks, protocol deviation/CAPA systems, TMF/eTMF health checks), led Gap Analysis and Remediation initiatives (process mapping, risk-based prioritization, CAPA design and effectiveness checks, remediation planning), and overseen Vendor Management (needs assessment, RFP and selection, qualification, Quality Agreements, performance/oversight, and issue escalation). I also support validation and governance of clinical systems (EDC, CTMS, eTMF) and the operational controls that keep data integrity and patient safety at the center.

I started QST because I saw a real need for practical, personable, and value-added consulting. My approach is simple: identify the needs, plan a sensible path, and execute within time and budget.

We’ve all experienced poor management of timelines and resources. We understand the pitfalls of compliance projects and can anticipate the obstacles that derail scope and inflate cost. QST invests upfront to evaluate scope realistically, define roles transparently, and build a true partnership that lasts well beyond successful project completion.