Cloud Compliance / CSV / Digital Trust
David Blewitt
VP of Cloud Compliance
David Blewitt helps life sciences companies keep regulated systems compliant as cloud platforms, applications, and operating models change. He brings more than 30 years of experience across pharma, medical device, biotech, and blood management organizations, with deep work in computer systems validation, risk management, quality assurance, software development, product life cycle management, and compliance roadmap development.
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 he helps clients solve it
David Blewitt's Resources
Resources that prove the expertise.
A focused shelf of content tied to David's work across cloud compliance, computer systems validation, regulatory risk, and digital trust 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.
March 16, 2020
Regulatory Risk Reduction in the Cloud: Why Cloud Systems Are Safer Than On-Premise Systems
A cloud risk paper explaining how regulated companies can reduce validation burden while maintaining 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.