Five focus areas, drawn from 25+ years of hands-on GxP quality leadership.
Leading AI adoption in CSV/CSA validation programs — guiding organizations through the shift from traditional Computer System Validation to risk-based Computer Software Assurance, incorporating AI-enabled validation approaches where they add real efficiency and defensibility.
Standing up quality management systems on modern CSA principles and current industry best practices — for organizations building GxP infrastructure for the first time or overhauling legacy approaches.
Advisory across TrackWise (On-Prem and Digital), Veeva Vault QMS, and other EQMS platforms — supporting clients through platform transitions, consolidations, and modernization roadmaps.
Supporting quality systems continuity and separation through mergers, acquisitions, and Transition Service Agreements — including system harmonization, data migration, and GxP compliance continuity across ownership changes.
Quality and compliance governance across GCP, GMP, and GLP environments, including inspection readiness and C-suite quality strategy. Experience also extends to broader GxP systems — CTMS, EDC, eTMF, and CDMS — where quality and validation oversight is needed.
TrackWise & TrackWise Digital · Veeva Vault QMS · ValGenesis VLMS · LabVantage LIMS
Most engagements begin with a short conversation about where your quality systems stand today.
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