White papers

Governance, Validation, Architecture, and Cost Resilience in Regulated Life Sciences - a strategic framework for CEOs, CIOs, CTOs, CCOs, and VP Regulatory Affairs.

Download USDM's AI governance for life sciences white paper for an enterprise framework covering GxP AI governance, vendor risk, lifecycle controls, and compliant AI adoption.

Most life sciences teams run Veeva Vault like a commodity system—paying premium costs while legacy CSV support holds them back. Download our white paper to learn how to build an AI-ready Vault operating model that reduces validation overhead, standardizes governance, and safely activates AI in GxP workflows.

A practical dossier of 47 inspection-ready AI use cases across Quality, Regulatory, Clinical, Manufacturing, Safety, Medical Affairs, Cybersecurity, and Corporate functions — each mapped to a maturity progression and defensible, audit-ready architecture for life sciences leaders.

A practical white paper for life sciences Quality, Security, Compliance, and Procurement teams on replacing annual vendor questionnaires with continuous assurance — governing third-party and AI-enabled partner risk in an inspection-ready ecosystem.

A practical guide to applying agentic AI and intelligent workflows across clinical, regulatory, quality, and operations in biotech and pharma — accelerating high-value work while preserving governance, validation evidence, and human oversight.

A practical white paper on using PTC ThingWorx, IoT, AI, and digital twins to connect GxP manufacturing, lab, and quality operations — improving product quality, reducing downtime, and strengthening data integrity without increasing regulatory risk.

A practical guide to adopting AI and generative AI responsibly in life sciences—how a purpose-built, compliance-first framework helps you surface high-quality insights from your data while mitigating regulatory risk.

A practical white paper on governing Generative AI in life sciences — pairing AI governance guardrails with citizen development so teams accelerate innovation without sacrificing compliance, patient safety, or data integrity.

A practical USDM white paper on running inspection-ready virtual audits and regulatory inspections — secure evidence exchange, controlled remote walkthroughs, remote vendor qualification, and a defensible GxP audit trail.

A USDM white paper on the five trends shaping life sciences in 2024 — from AI-ready data and operational debt to smart quality and workforce reskilling — and how to turn data into patient value.

A practical white paper for Quality, Regulatory, IT, and Data leaders on governing, validating, and monitoring AI in GxP workflows ahead of FDA and global regulatory expectations.

A USDM white paper on evaluating eSignature solutions through a security and data-integrity lens — identity assurance, encryption, audit trails, AI-enabled workflows, and vendor oversight so digital signing scales without weakening trust in the regulated record.

A digital-forward white paper on integrated GxP compliance — uniting USDM Cloud Assurance, ProcessX, and the Cloud Assurance Dx dashboard to harmonize compliance and innovation across regulated cloud and on-premises systems.

A practical guide to FD&C Act Section 524B: why cybersecurity now matters for connected medical devices, the risks manufacturers face, and 9 steps to meet FDA premarket submission requirements. Download the white paper.

A practical guide to clarifying validation responsibilities for SaaS and cloud GxP systems—what vendors provide, what your regulated company still owns, and how to apply CSA and risk-based evidence to close the gaps.

Explore five technology trends—automation, data collaboration platforms, cloud landing zones, AR/VR, and IoT—that help pharma, biotech, and medical device companies modernize while staying compliant. Download the white paper.

A practical white paper on applying blockchain to pharmaceutical supply chains and QMS — strengthening traceability, chain of custody, data integrity, and anti-counterfeit controls in regulated life sciences.

Learn how a building-block, Computer Software Assurance (CSA)-aligned approach automates validation, regression testing, and change control across your GxP cloud tech stack to cut compliance time and cost.

A white paper on building secure, inspection-ready Google Cloud programs for life sciences — aligning GxP controls, identity and access, data governance, DevOps evidence, and USDM Cloud Assurance from the start.

A practical white paper on raising compliance maturity in life sciences—covering security regulations, smarter automation, a quality culture, cloud adoption, and putting data and AI to work.

USDM's white paper on why life sciences teams outsource cloud vendor qualification — covering vendor assurance reports, SLA review, audit readiness, and ongoing GxP cloud compliance through change.

A practical guide to Computer Software Assurance (CSA) for life sciences: how risk-based testing, critical thinking, and leveraged evidence modernize software validation while strengthening product quality and patient safety.

A practical readiness guide to EU Medical Device Regulation (EU) 2017/745—what changed from the MDD and AIMD directives, how device classification, vigilance, registration, and post-market surveillance work, and how to stay compliant for the European market.

See how Box and USDM Life Sciences help regulated teams govern content, automate validation evidence, and maintain GxP compliance and inspection readiness in the cloud.

A USDM white paper on the 2022 trends reshaping life sciences — from Computer Software Assurance and AI-infused GxP process automation to data-driven decision intelligence and a better employee experience.

A USDM white paper on running regulated GxP workloads in the public cloud — why life sciences lagged on cloud adoption, what changed, and how continuous compliance with USDM Cloud Assurance spans IaaS, PaaS, and SaaS.

A USDM white paper on UDI direct marking for medical devices in the U.S. and Europe — how to determine applicability, compare FDA and EU MDR/IVDR expectations, choose marking technologies, and document exceptions without creating inspection risk.

A practical white paper on the FDA's anticipated Computer Software Assurance (CSA) guidance for manufacturing, operations, and quality system software — why the Case for Quality approach matters and how it streamlines validation for life sciences device makers.

A practical guide to adopting PTC ThingWorx Industrial IoT in GxP regulated life sciences operations — using risk-based validation, data integrity controls, and lifecycle governance so connected manufacturing improves visibility without weakening compliance.

A practical white paper on building a phase-appropriate quality management system (QMS) for emerging life sciences organizations — aligning QMS practices with FDA, ISO, and ICH Q10 expectations to support strategic quality objectives. Download it today.