Webinar: Beyond Compliance: Data Integrity and Quality Management Systems as Knowledge Governance
Sponsored by: SIG Knowledge Management (SIG-KM)
Quality management systems (QMS) and data integrity programs have long been treated as compliance obligations and necessary infrastructure and rarely examined as strategic knowledge assets. This presentation challenges that framing. Drawing on the author's experience leading the development of data integrity standards (ASQ TR3:2022) and his decades of regulatory operations practice, this session reframes two foundational disciplines through a knowledge governance lens. First, QMS workflows (such as standard operating procedures, change controls, audit findings) represent some of the densest concentrations of operational knowledge in any organization. When managed as living knowledge assets rather than siloed compliance documents, they become powerful engines for continuous improvement and inspection readiness. Second, data integrity is reconsidered not merely as a technical or procedural control, but as a knowledge problem: the meaning of a record, the context of its generation, and the provenance of its metadata are fundamentally questions of organizational knowledge, the absence of which being as much an epistemic failure as a regulatory one. Together, these perspectives offer a more integrated model of quality and knowledge management with direct implications for early-stage organizations building regulatory infrastructure, fractional and distributed operating models, and the broader application of artificial intelligence to regulated data.
Presenter
Kip Wolf
Kip Wolf is founder & CEO of Thaumazo Bioscience Management providing growth acceleration and operational transformation services for life science ventures through fractional executive leadership and advisory services that are delivered in phase-appropriate right-sized fit-for-purpose solutions by way of fixed fee and retainer-based engagements to maximize capital efficiency. The firm advises forward-thinking companies at the intersection of regulatory science, digital transformation, and strategic growth to implement innovative, compliant, and commercially viable solutions. Kip has spent over thirty years in information systems, focusing on the human-centered influence on data integrity and data quality, during the last nine years of which leading industry research in artificial intelligence in operations of life science manufacturing and post-marketing surveillance. He has presented and published extensively on the topic of data integrity in online articles and in business publications. Through ongoing applied research, he aims to investigate how data creation processes, digital curation practices, provenance standards, metadata and paradata governance, and risk-based data lifecycle methods can support the accurate interpretation and reuse of data that is used to influence and inform human health outcomes. He has completed formal graduate studies in Drug Development at Temple University and holds an undergraduate degree in Management of Information Systems and an MBA from Eastern University.
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