AI Governance / Digital Trust / Cloud Compliance
David Blewitt
VP of AI Governance and Digital Trust
David is a Life Sciences AI Governance and Compliance leader and Key Opinion Leader, specializing in the validation, assurance, and risk management of AI/ML and Generative AI technologies across the pharmaceutical, medical device, biotech, and blood management industries. He designs and implements bespoke risk identification, remediation, and validation strategies for AI-enabled GxP systems spanning SaaS, IaaS, PaaS, and WaaS platforms, with deep expertise in AI Governance, Computer Software Assurance, Computer Systems Validation, and Cloud Compliance. At USDM, David sits as a standing member on the AI Governance Committee, and spearheaded the creation of Cloud and AI Assurance Certified—USDM's proprietary "Badge of Trust" certification that enables life sciences organizations to demonstrate cGxP and AI readiness in an era of rapidly evolving regulatory expectations.
Cloud compliance
Guides validation and assurance for GxP cloud systems, SaaS applications, and regulated digital platforms.
Regulatory depth
Applies predicate-rule and guidance expertise across 21 CFR, GAMP 5, ICH Q7, and modern CSV/CSA expectations.
Lifecycle control
Connects quality, risk, software development, and product lifecycle practices into defensible compliance roadmaps.
David Blewitt's Credentials
David helps regulated teams move cloud systems forward without turning validation into a recurring excavation project.
His work focuses on the controls life sciences companies need when regulated systems move to the cloud: validation strategy, predicate-rule interpretation, risk-based assurance, release readiness, and audit-ready evidence.
Proof points
30+ years of experience across pharma, medical device, biotech, and blood management organizations
Expertise in computer systems validation, risk management, quality assurance, and software development
Regulatory experience spanning 21 CFR Parts 11, 203, 210, 211, 801, 803, 820, and 821
Cloud validation and assurance experience across patient case management, sample tracking, content collaboration, adverse event, and dispositioning systems
Primary role
Cloud compliance
Helps organizations validate, maintain, and govern regulated cloud systems without losing audit readiness as platforms change.
Where he helps
CSV and regulatory risk
Supports risk-based validation, predicate-rule interpretation, quality alignment, and practical compliance roadmaps.
How David helps clients solve it
David Blewitt's Resources
Resources that prove the expertise.
A focused shelf of content tied to David's work across AI governance, digital trust, cloud compliance, computer systems validation, and regulatory risk leader.
January 16, 2022
An Introduction to Computer System Validation
A foundational CSV webinar for life sciences teams selecting, validating, and maintaining regulated systems.
April 2, 2022
Oracle Validation and Assurance Virtual Roundtable
A regulated cloud operations discussion on Oracle validation, assurance, and compliance expectations.
September 19, 2021
Regulated GxP Workloads in the Public Cloud
Guidance for life sciences teams moving regulated workloads to public cloud environments without weakening compliance control.
April 24, 2022
Box Meets Complex Security and Global GxP Validation Requirements
How USDM enabled FDA-ready Box GxP validation for a global biosciences company with complex requirements.
April 19, 2022
Box GxP and Cloud Assurance for FDA Submission
A Box GxP and Cloud Assurance case study tied to validation evidence and FDA submission readiness.
January 18, 2024
Using AI to Help Ensure Compliance while using eSignatures
How AI and machine learning can contribute to secure, compliant signing processes in life sciences.
March 8, 2022
Cloud 101: Part 1 - Cloud Service Models
An introduction to IaaS, PaaS, and SaaS models for teams planning regulated cloud adoption.
March 28, 2022
Data in the Cloud Can Be 21 CFR Part 11 Compliant
A practical view of how life sciences companies can maintain Part 11 compliance in cloud environments.
Contact David Blewitt
Start a conversation about cloud compliance before the next release turns into a validation fire drill.
Use the form to route a conversation about CSV, GxP cloud assurance, 21 CFR Part 11, predicate-rule interpretation, release readiness, or compliance roadmap planning.