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Five Questions Every Biotech Executive Should Be Asking After the Novo Nordisk Breach
What the Novo Nordisk breach reveals about clinical research data, cyber extortion, third-party exposure, and executive risk management for biotechnology leaders.
HL7 FHIR and ePI: Why Structured Product Information Is the Next Step in Regulatory Modernization
Why HL7 FHIR-based electronic product information requires more than data mapping, and how life sciences teams can prepare the governance, validation, and operating model behind structured medicinal product information.
ServiceNow as the Compliant Workflow Engine for Life Sciences
Watch this on-demand webinar with ServiceNow and USDM Life Sciences to see how Compliant Contact Center connects complaints, CAPA, regulatory submissions, and other GxP-relevant workflows in an audit-ready ServiceNow operating model.
Application Lifecycle Management for Regulated Life Sciences Systems
How ProcessX connects ALM, validation lifecycle management, change control, regulatory applicability, CSA, and continuous evidence for GxP systems.
AI Governance Is No Longer Just a Technology Problem
AI is becoming an operational dependency for life sciences organizations. Brian Rankin explains why governance maturity, concentration-risk oversight, and executive accountability need to evolve with adoption.
eForms and eLogbooks for GxP Workflows
ProcessX eForms and eLogbooks help life sciences teams digitize regulated data capture, reduce paper-driven errors, preserve audit trails, and support data integrity in GxP workflows.
90-Day AI Readiness for Life Sciences
A 90-day AI readiness assessment for life sciences: inventory use cases, classify risk, map data and platform controls, select pilots, and build a governed adoption roadmap.
Claude in GxP AI Governance and Validation
A practical USDM framework for Claude GxP validation: intended use, risk classification, data controls, human review, testing, monitoring, and change control for regulated AI adoption.
MCP, Connectors, and Skills: The New Integration Layer for Regulated AI
Learn how life sciences teams can govern MCP, Claude connectors, and Skills as a regulated AI integration layer with access controls, validation evidence, and change management.
Business Intelligence & Analytics for Life Sciences: Turning Regulated Data into Better Decisions
Discover how business intelligence and analytics help life sciences organizations improve compliance, accelerate insight, and drive smarter decisions across clinical, quality, regulatory, and commercial operations.
Citizen Development at AI Speed: Governance Risks for Life Sciences
AI-assisted citizen development can bypass governance controls. Learn the cybersecurity, validation, and data risks life sciences organizations need to manage.
Data Integration & Interoperability in Life Sciences: How to Build a Connected, Compliant Data Ecosystem
Learn why data integration and interoperability are critical in life sciences, and how connected, standards-aligned data improves compliance, speed, visibility, and AI readiness.
Compliant Workflow Automation in Life Sciences: How to Move Faster Without Losing Control
Learn how compliant workflow automation helps life sciences companies reduce manual effort, improve traceability, and scale regulated operations without compromising GxP compliance.
Audit-Readiness in Life Sciences: Continuous Compliance as Regulatory Defensibility
Audit-Readiness in life sciences depends on continuous compliance, traceability, and defensible processes that keep teams prepared for inspections year-round.
Compliant Contact Center for Life Sciences
ProcessX Compliant Contact Center brings adverse event intake, complaint handling, post-market surveillance, and regulated case workflows into ServiceNow with traceability and human-reviewed AI triage.
EU MDR/IVDR EUDAMED Readiness: What Medical Device Manufacturers Need to Do Now
Learn how to improve EU MDR/IVDR EUDAMED readiness with practical steps for data, registration, governance, and global medical device regulatory alignment.
AI Readiness Assessment for Life Sciences
How life sciences organizations assess AI readiness — data foundation, governance maturity, infrastructure, talent, validation capability, and the structured assessment that turns AI ambition into AI execution.
Data Classification in Life Sciences: The Boring Work That Makes AI Possible
Why data classification is the unglamorous prerequisite for AI readiness in life sciences — sensitivity tiering, two-horizon planning, phased implementation, and the boundary discipline that makes Search AI and agentic AI safe.
From Phase 3 Win to NDA: The GxP Readiness Gaps That Sink Clinical-Stage Oncology Biotechs
Why biotech companies with strong Phase 3 data still stumble at NDA — the GxP readiness gaps in quality systems, validation, data integrity, and regulatory infrastructure that derail clinical programs.
When Your Clinical Trial Sites Go Dark: What the Stryker Cyberattack Means for Biotech and Pharma
What the Stryker cyberattack teaches life sciences about clinical trial site resilience — when hospital systems go dark, clinical data integrity, patient safety, and trial continuity are all at risk.
The Top 10 AI Use Cases Life Sciences Leaders Should Be Prioritizing Now
The top AI use cases life sciences leaders should prioritize now—GxP-grade, inspection-ready capabilities that cut compliance cost and accelerate workflows.
5 Ways AI is Transforming Clinical Trials
Five ways AI is transforming clinical trials — from trial design and patient recruitment to site monitoring, data management, and regulatory submissions. Practical applications with governance considerations for life sciences.
What Is GxP Compliance?
GxP compliance protects product quality, patient safety, and data integrity across regulated life sciences processes, from manufacturing and laboratories to clinical operations and digital systems.
Why AI Adoption Is Failing in Life Sciences
Why AI adoption stalls in life sciences — pilot paralysis, data foundation gaps, governance theater, vendor sprawl, and the structural shifts organizations need to move from AI experimentation to AI impact.
What’s Actually Compliant in AI for Life Sciences? A 2026 Reality Check
A 2026 reality check on what is actually compliant in AI for life sciences: how to read FDA credibility expectations and the EU AI Act, keep humans in the loop, validate GenAI like regulated software, and scale from pilot to production without compromising GxP compliance.
EUDAMED Has Landed – What It Means for You, Now
Watch this on-demand session with Jay Crowley on the EUDAMED mandatory-use milestone: what the first four modules activate, why May 28, 2026 matters, and how to turn MDR/IVDR and UDI data readiness into a practical plan.
The Hidden Costs of Offshore IT Projects in Life Sciences: Why Local Expertise Matters
Offshore-dependent IT projects in life sciences carry hidden costs in rework, compliance risk, and operational disruption. Learn why local, GxP-fluent expertise and direct accountability deliver enterprise system success.
UDI Compliance and the Future of Medical Device Data
EUDAMED is here and the UDI spreadsheet sprint won't scale. Learn how a holistic data superset, a Single Source of Truth, and cross-organization governance keep medical device data consistent, compliant, and ready for global market access.
Beyond Automation: Orchestrating the Future of Validation with GenAI and ProcessX
How ProcessX helps life sciences teams govern GenAI-enabled validation workflows, agentic actions, Veeva integration, human review, and audit-ready evidence.
The Model Context Protocol (MCP) in Life Sciences
The Model Context Protocol (MCP) turns AI models into active agents that can query and act on regulated systems like QMS, LIMS, and EHRs. Learn how life sciences teams secure and govern MCP to protect HIPAA, GxP, and 21 CFR Part 11 compliance and data integrity.
EU AI Act Compliance for Pharma and Life Sciences: What to Prepare Before August 2026
EU AI Act compliance is becoming a practical readiness issue for pharma, medtech, biotech, and life sciences teams using high-risk AI systems in regulated workflows.
Evaluating Google Agentspace for Life Sciences
A practical 10-factor framework for life sciences teams evaluating Google Agentspace—covering GxP compliance, data security, auditability, multi-agent governance, and ROI for confident, validated AI adoption.
Maximizing ROI with the Common Service Data Model
How CSDM helps life sciences IT teams connect ServiceNow data, business services, audit readiness, and portfolio decisions to measurable ROI.
Security Over Speed: Applying J.P. Morgan’s Cybersecurity Risk Mandate to Life Sciences Vendors
What life sciences can learn from J.P. Morgan's cybersecurity risk management — prioritizing security over speed, board-level accountability, third-party oversight, and building resilient cyber programs for regulated environments.
Out-of-the-Box Validated Workflows for Audit-Ready Quality Teams
How prevalidated ProcessX workflows help life sciences Quality teams reduce manual audit prep, strengthen traceability, and maintain inspection readiness every day.
EUDAMED Challenges for Medical Device Manufacturers: Future-Proof Your 2025 Compliance Strategy
Watch this on-demand webinar with USDM Life Sciences and BYRD Health to learn how medical device manufacturers can achieve audit-ready EUDAMED and UDI registration before the early-2026 MDR deadlines.
Navigating ICH E6(R3) with Confidence – A New Standard for IT Governance in Clinical Research
Watch this on-demand webinar to see how USDM's CRO Assurance helps sponsors meet ICH E6(R3)'s new continuous IT governance and CRO oversight requirements with confidence.
Reimagining Biotech and Pharma: The Rise of Agentic AI and Intelligent Workflows
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.
Offensive Security Testing in Life Sciences Lab Environments
Offensive Security Testing simulates real-world attacks to expose hidden vulnerabilities in life sciences labs. Learn how proactive testing, Zero Trust, and microsegmentation protect research data and keep regulated environments compliant.
The DM Clinical Research Data Breach: A Stark Reminder of Third-Party Risk in Life Sciences
The DM Clinical Research breach left a misconfigured database of roughly 1.6 million clinical trial records exposed online. Here is what life sciences organizations should learn about third-party risk management, vendor security, and protecting patient PHI.
Third-Party Risk Management for Life Sciences
A practical guide to third-party risk management (TPRM) for life sciences: how to assess vendors, prove compliance with 21 CFR Part 11, ISO 27001, NIST, and GxP, and protect critical data across your vendor ecosystem.
Seamless Compliance and Cost Savings with USDM’s Veeva-DocuSign Integration Accelerator
USDM’s Veeva-DocuSign Integration Accelerator lets life sciences teams capture compliant eSignatures from external signers without extra Veeva licenses—cutting cost and complexity while preserving 21 CFR Part 11 audit readiness.
Cybersecurity Challenges and Solutions for Emerging Biotech Companies
Emerging biotech and biopharma companies face rising threats to their IP, clinical data, and regulatory compliance. Learn how USDM's Virtual CISO (vCISO) services deliver scalable, risk-based security leadership to protect your most valuable assets.
Smart Strategies for Life Sciences: Leveraging Data for APM Excellence
Watch this on-demand webinar with Blue Mountain and USDM to learn how life sciences teams connect asset, maintenance, and calibration data to improve uptime, defend compliance, and apply AI to asset performance management without losing GxP discipline.
Transforming Enterprise Asset Management
How life sciences manufacturers transform enterprise asset management — modern EAM platforms, IoT integration, predictive maintenance, and GxP-compliant equipment lifecycle management.
USDM Life Sciences Summit 2025
Watch the USDM Life Sciences Summit 2025 on demand — four expert panels on data integrity, intelligent automation, AI use cases, and strategic technology alliances that turn data into a compliant advantage for regulated life sciences organizations.
Transformative Outcomes in Life Sciences
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.
Drive Superior Business Insights through Advanced Data Integration in Life Sciences
Learn how advanced data integration in life sciences breaks down data silos, strengthens data quality and governance, and turns fragmented R&D, clinical, and supply chain data into superior business insights.
Leveraging Hybrid Cloud and Integration Services in Regulated Life Sciences
Learn how hybrid cloud architectures and integration services help regulated life sciences organizations balance flexibility, scalability, and data security while meeting HIPAA, GDPR, and FDA compliance requirements.
Metadata Management & Content Searchability in Life Sciences
Strong metadata management is what makes life sciences content searchable, integrable, and audit-ready. Learn the strategy, best practices, and compliance benefits of treating metadata as a core data asset.
How Secure API Management Transforms Data Exchange in Life Sciences
Learn how secure API management enables compliant, high-volume data exchange in life sciences, from OAuth 2.0 and TLS encryption to API gateways, governance, and audit-ready documentation that align with HIPAA, GDPR, and FDA expectations.
Transforming Data into Actionable Insights with Tailored BI Dashboards
Learn how tailored business intelligence (BI) dashboards turn complex life sciences data into real-time, role-based insights that sharpen decision-making, lift operational efficiency, and keep teams aligned to strategy.
Version Control & Audit Trails in Life Sciences
Version control and audit trails are the foundation of data integrity and regulatory compliance in life sciences. Learn best practices for change tracking, immutable audit trails, electronic signatures, and audit-ready record histories.
Best Practices for Managing Content in Emerging Biopharma and Regulated Life Sciences Companies
A practical playbook for emerging biopharma and regulated life sciences teams: govern, scale, and validate content management systems to reduce compliance risk and control costs as you grow.
Data Integrity in Life Sciences: Best Practices for Compliance, Quality, and AI Readiness
Data integrity best practices for life sciences — ALCOA+ principles, audit trails, electronic records, AI readiness, and how to build a quality culture that satisfies FDA, EMA, and global regulators.
Drive Business Growth and Efficiency with a Strategic Data Roadmap
Learn how a strategic data roadmap helps life sciences and biotech companies centralize, optimize, and scale their data to drive growth, ensure GxP and GDPR compliance, and accelerate innovation.
Boost Efficiency and Anticipate Trends with AI-Driven Predictive Analytics in Life Sciences
AI-driven predictive analytics helps life sciences organizations accelerate drug discovery, sharpen demand forecasting, and reduce manufacturing downtime. Explore the use cases, best practices, and governance steps for putting predictive AI to work.
Digital Innovation in Life Sciences: Ensure Compliance with Oracle CloudSure
Watch this on-demand webinar to see how Oracle CloudSure, built for life sciences, helps GxP organizations accelerate continuous compliance, reduce SaaS risk, and innovate confidently in the cloud.
Achieving Data Quality and Regulatory Compliance Through Robust Governance
How life sciences organizations build data governance programs that ensure regulatory compliance, data quality, and audit readiness — from classification and lineage to stewardship and lifecycle management.
Getting Started with the Common Service Data Model
A practical introduction to ServiceNow CSDM, CMDB relationships, service modeling, data quality, and governance for regulated life sciences teams.
Achieving Unprecedented Value from your Veeva Investments
Unlock the full value of your Veeva investment with USDM Life Sciences. Break down data silos, overcome integration barriers, and tame platform complexity with tailored, GxP compliance-ready solutions.
Penetration Testing in Life Sciences Lab Environments
Penetration testing exposes hidden vulnerabilities before attackers do. Learn how to plan risk-aware pen testing for life sciences labs without disrupting sensitive research, instruments, or data integrity.
Data Rich and Information Poor
Many life sciences organizations are data rich but information poor. Learn how USDM unifies, governs, and operationalizes data to drive compliant, AI-ready, data-driven decisions.
How to Fulfill Expectations for Data Privacy and Security
A practical guide for life sciences teams on the tools, controls, and outsourcing decisions that protect data confidentiality, integrity, and availability while meeting GDPR, HIPAA, and CCPA expectations.
Manual Testing vs. Automated Testing
Compare manual testing and automated testing for GxP software, and see how automated regression testing improves accuracy, scalability, and speed in regulated life sciences environments.
The Importance of CIS Critical Security Controls (CIS18) in Life Sciences
High-profile breaches across biotech, pharma, and medical device companies show why life sciences needs disciplined cybersecurity. Learn how the CIS Critical Security Controls (CIS18) and Implementation Group 1 help you reduce risk and build a defensible security program.
Understanding Regulatory Applicability Assessments
A regulatory applicability assessment helps life sciences teams determine which laws, standards, controls, and validation activities apply to a system, process, or digital workflow.
Workforce Optimization: Maximizing Employee Efficiency and Productivity
Workforce optimization puts the right people on the right tasks at the right time. Explore data-driven strategies and delivery models that boost efficiency, productivity, and compliance in life sciences.
Mandatory Use of EUDAMED Now Starting Q1 2026
Watch this on-demand webinar from USDM Life Sciences and BAYARD to understand the EU's gradual EUDAMED roll-out, why mandatory UDI and device registration now starts in Q1 2026, and how to manage your UDI data to meet the deadline.
Smart Quality: AI-Enabled Quality Management for Life Sciences
How Smart Quality connects AI, automation, data integrity, paperless GxP workflows, ProcessX, and Cloud Assurance to improve life sciences quality management.
Ensuring AI Compliance and Maximizing the Value of Your GxP Technologies
Watch this on-demand webinar with Google, Sorcero, and USDM on how a purpose-built, compliant AI solution helps life sciences organizations adopt AI responsibly and mitigate risk across GxP technologies.
Accelerate Your AI Journey with Specialized Services from USDM Life Sciences
USDM's specialized services support every stage of the life sciences AI journey, from governance and data readiness to cybersecurity, talent, and compliant cloud deployment. Explore the questions and capabilities that move AI initiatives forward.
Best Practices for a Healthy Configuration Management Database
How life sciences teams can keep ServiceNow CMDB data complete, compliant, correct, and useful for regulated ITSM, CSDM, ProcessX workflows, and audit-ready operations.
A Comprehensive Guide to Responsible AI for Life Sciences
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.
AI Governance and Citizen Development for GenAI in Life Sciences
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.
Mastering Periodic Review in GxP Environments
How periodic review helps life sciences teams maintain validated systems, confirm data integrity, adjust review frequency, and keep GxP evidence inspection-ready.
Reshaping Recruitment and Staffing Strategies with AI Tools
See how AI tools reshape life sciences recruitment—faster candidate sourcing, smarter resume screening, and data-driven hiring decisions—while keeping human judgment and bias mitigation at the center.
Good Machine Learning Practice (GMLP) for Medical Device Development: Guiding Principals
A practical guide to the 10 Good Machine Learning Practice (GMLP) guiding principles for medical device development, plus how ethics, data integrity, and model transparency keep AI-enabled devices safe, reliable, and compliant.
2024 Trends in Life Sciences
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.
An Unprecedented Data Revolution in Life Sciences
Genomics, wearables, and real-world evidence are flooding life sciences with data. Learn how Data Mesh, Data Fabric, and the DIKW model turn that deluge into AI-ready, governed, decision-grade insight.
Minimize Operational Debt by Modernizing and Automating
Operational debt from manual processes, siloed data, and legacy systems quietly erodes agility and margins. Learn how modernizing and automating GxP operations turns that burden into a competitive advantage.
A Few Surprises in FDA's Quality Management System Regulation
FDA's Quality Management System Regulation (QMSR) harmonizes 21 CFR 820 with ISO 13485:2016 — and brings two underdiscussed surprises: expanded traceability for implantable and life-sustaining devices, and a true regulatory basis for the risk-based Computer Software Assurance (CSA) approach to validation.
Anticipating Regulatory Compliance for Artificial Intelligence in Life Sciences
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.
RPA GxP-relevant Use Cases
Explore practical, GxP-relevant robotic process automation (RPA) use cases for life sciences—from complaint handling and clinical data extraction to data migration and regulatory compliance—and how a compliance-first framework keeps your bots audit-ready.
Enhancing Security and Ensuring Data Integrity in eSignature Solutions
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.
Use AI to Personalize the eSignature Experience in Life Sciences
Learn how AI-assisted adaptive interfaces personalize the eSignature experience in life sciences — improving accessibility, engagement, and multinational compliance while preserving FDA 21 CFR Part 11 audit trails.
Maximize eSignature Security with AI in Life Sciences
How AI-enhanced eSignature security strengthens 21 CFR Part 11 compliance — multi-factor verification, behavioral biometrics, signature anomaly detection, and modern identity assurance for regulated workflows.
Anticipating the Use of Generative AI in Life Sciences
How life sciences organizations anticipate and prepare for generative AI — emerging use cases, governance requirements, data foundation work, and the strategic decisions that determine whether GenAI accelerates or stalls.
Applying Pharma 4.0 and GMP to Manufacturing Processes
How Pharma 4.0, digital quality, AI, automation, and ProcessX help life sciences manufacturers modernize GMP workflows while preserving data integrity, validation evidence, and audit-ready control.
Automate Now | Best Practices for GxP Systems
Watch this on-demand webinar with USDM subject matter experts on best practices for GxP systems—covering automated testing, IT change management, and AI to decrease risk and increase operational efficiency.
Managing Generative AI Risk for Life Sciences Use Cases
A practical risk management framework for generative AI in life sciences — addressing hallucination, IP exposure, data privacy, regulatory compliance, and building governed AI use cases that regulators can trust.
Integrated GxP Compliance
Watch this on-demand webinar to see how USDM Integrated GxP Compliance—a modern managed service—helps pharma, biotech, and medical device companies harmonize compliance with technology, automate validation, and accelerate innovation across cloud and on-premises GxP systems.
Integrated GxP Compliance for the Life Sciences Industry
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.
Reducing Cybersecurity Risks: A Primer for Emerging Life Sciences Firms
A cybersecurity primer for emerging life sciences companies — building security programs from the ground up, protecting IP and patient data, meeting regulatory expectations, and avoiding the mistakes that early-stage companies make.
Addressing cybersecurity concerns in the life sciences industry
Life sciences companies are prime targets for cybercriminals. Learn how to build a right-sized, NIST-aligned cybersecurity program that grows with your organization and protects sensitive data, IP, and your supply chain.
Validation Requirements and Responsibilities
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.
Good Clinical Practices (GCP): Ensuring Ethical and Reliable Clinical Research
A practical guide to Good Clinical Practices (GCP): the core principles, investigator responsibilities, informed consent, monitoring, and data integrity that keep clinical trials ethical, compliant, and reliable.
Good Laboratory Practices (GLP): Ensuring Quality and Reliability in Scientific Research
A practical guide to Good Laboratory Practices (GLP) for life sciences: core principles, regulatory compliance with FDA and EMA, data integrity, and how to maintain scientific rigor in non-clinical studies.
An Update on the FDA’s UDI and GUDID Compliance Requirements
On-demand webinar with Jay Crowley on the FDA’s tightening UDI and GUDID requirements — closing Legacy Identifier gaps, UDI in routine inspections and import screening, and how labelers can align GUDID data across FDA systems before enforcement reaches them.
Managing GxP Workflows & Continuous Cloud Compliance with ProcessX and ServiceNow
Watch this on-demand webinar to see how ProcessX on ServiceNow helps life sciences teams automate GxP and non-GxP workflows, preserve 21 CFR Part 11 controls, and scale regulated processes in a state of continuous compliance.
Simplify GxP Quality Assurance
On-demand webinar: ZenQMS and USDM Life Sciences show how to simplify selecting, qualifying, and validating cloud-based eQMS systems for GxP — and how Cloud Assurance reduces your validation burden.
How to Use BI & Data Analysis to Create Efficient Business Processes
Turn the data your life sciences organization already collects into actionable insight. Learn how business intelligence and the four types of data analytics streamline workflows, automate GxP processes, and drive better decisions.
NetSuite for GxP, Regulated Use Cases
Watch this on-demand webinar to see how life sciences organizations use NetSuite for GxP-regulated processes — from item and material management to 21 CFR Part 11 e-records, audit trails, and e-signatures — and how USDM reduces the compliance burden.
Best Practices for Software Vendor Qualification
A practical guide to qualifying software vendors for life sciences: define requirements, evaluate capabilities and credentials, audit quality processes, and leverage vendor testing to streamline compliance.
Emerging Life Sciences Virtual Event
Watch this on-demand virtual event, hosted by USDM Life Sciences with Box, for thought-leader guidance on IT and quality strategy, GxP cloud compliance, automation, and compliant content management as emerging biotech, biopharma, and medical device companies move from R&D to commercialization.
2023 Technology Trends in Life Sciences
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.
Applications of Blockchain Technology Within Pharmaceutical Supply Chain and Quality Management Systems
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.
Compliant IT Strategies On-Demand Webinar
Watch this on-demand webinar to build a compliant IT strategy for early-stage biotech, pharma, and medical device companies—from pre-clinical through commercialization—covering IT roadmaps, GxP and G&A needs, cybersecurity, and scalable resourcing models.
Computer Software Assurance (CSA) Draft Guidance Webinar
Watch this on-demand webinar with the FDA's Francisco Vicenty and USDM experts as they break down the Computer Software Assurance (CSA) Draft Guidance and what the shift from traditional CSV means for medical device, pharma, and biotech organizations.
UDI Beyond Borders
Watch the on-demand 12th annual UDI Conference, moderated by Jay Crowley — the original developer of the FDA's UDI requirements — for a global look at FDA, EU MDR/IVDR, and emerging international Unique Device Identification rules, plus the data quality and data management practices device manufacturers need to comply.
Five Tips for GxP Vendor Qualification
A practical, risk-based guide to qualifying GxP software and cloud vendors in life sciences. Learn how to clarify responsibilities, leverage vendor documentation, manage cloud updates, and write SLAs that protect compliance.
Global UDI Data Management – The New Paradigm
Watch this on-demand webinar on managing Unique Device Identification (UDI) data across the growing set of national UDI databases — from data mapping and transformation to maintaining continuous compliance with USDM Cloud Assurance for atrify.
Data Migration
Migrating regulated data to the cloud delivers scalability, cost-effective backup and archiving, and stronger security than traditional data centers, while establishing data governance and maintaining a continuously validated, GxP-compliant state.
Cloud 101: Part 3 – Embracing the Cloud
Cloud is no longer an emerging technology. Learn the constraints life sciences companies must break free from, the public cloud challenges and possibilities across the value chain, and how to manage risk on the path to becoming cloud-first.
Phased Migration of Critical Applications and Databases
Learn how a phased migration approach moves highly complex, external-facing GxP applications and databases to the cloud while controlling access to sensitive data, preserving compliance, and maintaining 24/7 business continuity.
Automating Validation Across Your Tech Stack
On-demand webinar: USDM experts walk through a forward-thinking approach to automating computer system validation and continuous compliance for modern GxP cloud technologies—so you can deploy faster without choosing between regulation and innovation.
The Evolving Global Medical Device Data Imperative
Global UDI and UDI-like regulations are forcing device manufacturers to break down data silos and manage device information across the full product lifecycle. Learn how to build a cross-organization, data-centric framework for global UDI submissions.
Process Automation for Regulated GxP Workflows
See how life sciences teams automate and scale regulated GxP business processes while preserving 21 CFR Part 11 e-signatures, audit trails, and continuous compliance. Real customer case studies from a USDM webinar.
GxP Expertise for Program and Project Management
USDM's project and program management experts lead and support mission-critical projects and highly regulated cloud technology implementations, combining GxP expertise with a proven, value-based methodology that keeps regulated programs on time and on budget.
List of Supported Regulations
A reference list of global life sciences regulations USDM Cloud Assurance supports — FDA, EMA, ICH, ISO, and country-specific frameworks across pharma, biotech, and medical devices.
Compliant Data Migration Solutions
Compliant data migration in life sciences is rarely a simple copy — it demands mapping, transformation, and validation. Learn how a GxP-ready migration plan protects data integrity and minimizes downtime.
Demystify FDA Compliance for Public Cloud Workloads in Life Sciences
Watch this on-demand expert roundtable from USDM Life Sciences and Data Intensity on adopting public cloud for FDA-regulated workloads while keeping GxP applications secure and compliant.
Q&A: EU MDR Date of Application Readiness
Expert answers to the most-asked EU MDR Date of Application questions—EUDAMED registration, SRNs, legacy device transitions, PSURs, UDI, and ISO 13485:2016—from USDM's medical device webinar with Jay Crowley.
FDA CBD Enforcement Report Released to Congress
The FDA's report to Congress lays out its enforcement priorities and safety concerns for CBD products. Learn what the agency's evolving oversight means for cannabis and CBD manufacturers, and how to align operations with FDA regulatory expectations.
4 Simple Steps to Ensure Data Integrity in Quality Control Labs
Reduce data integrity risk in your QC lab with four practical steps grounded in ALCOA principles: train your people, map your data lifecycle, automate workflows, and review data in near real-time.
Cannabis: Compliance in a Rapidly Changing Industry
Watch this on-demand webinar to understand the fragmented cannabis regulatory landscape, get a regulations and compliance overview, and learn from real FDA findings so you can prepare your company for evolving requirements.
Challenges with EU MDR and IVDR Compliance
Watch this on-demand webinar on EU MDR and IVDR compliance for medical device manufacturers — EUDAMED data requirements, UDI strategy, and the steps to take now to meet upcoming and future global deadlines.
EU MDR Date of Application Readiness
Watch this on-demand webinar for near-term and long-term EU MDR Date of Application (DoA) strategies — covering Directive, Legacy, and Regulation device requirements, EUDAMED timing, and the transitional deadlines running through 2025.
Evolving Global UDI Product Data Requirements
Watch this on-demand webinar on evolving global UDI requirements, where former FDA UDI architect Jay Crowley and atrify's Lionel Tussau explain how medical device manufacturers can manage regulatory, commercial, and patient-safety product data across EUDAMED, GDSN, and other global systems.
How to Get Results on Regulated Projects with Virtual Teams
Watch this on-demand USDM webinar for a practical playbook on running regulated GxP projects with virtual, distributed teams — covering virtual PMO best practices, compliant collaboration tools, common mistakes to avoid, and how to maintain business continuity and continuous compliance.
How to Comply with Saudi Arabia UDI Requirements
Watch this on-demand webinar to understand SFDA Unique Device Identification (UDI) requirements for medical devices and IVDs in Saudi Arabia, including SAUDI-D database submissions, labeling, and compliance deadlines by device class.
How to Maximize Your GxP Use of the Public Cloud
Watch this on-demand webinar to learn how life sciences teams scale GxP workloads in the public cloud while maintaining continuous compliance across IaaS, PaaS, and SaaS based on their cloud maturity.
SaMD Regulations and Compliant Development Environments
Watch this on-demand USDM webinar on Software as a Medical Device (SaMD): the U.S. and European regulations that apply, QMS considerations, and how to build a compliant, qualified IT development environment.
UDI Registration in EUDAMED – Why and How to Use It Now
Watch this on-demand webinar to learn how to register devices in EUDAMED's new UDI Database module, navigate MDR actor registration, and prepare for EUDAMED's future steps.
Virtual Audits and Inspections
Watch this on-demand webinar with USDM Life Sciences and Box to see how virtual audits streamline vendor and supplier qualification, support agency submissions, and keep records accessible for remote regulatory inspections.
Work Faster and Smarter in Biotech Quality Management
Watch this on-demand webinar to see how Box, ComplianceQuest, and USDM Life Sciences bundle quality management so biotechs cut stand-up times, control costs, and run a best-of-breed compliance stack.
An Introduction to Computer Software Assurance
Watch this on-demand webinar with USDM's Sandy Hedberg for a plain-language introduction to the FDA's Computer Software Assurance (CSA) approach — what it means for regulated life sciences companies and how this risk-based alternative to traditional CSV can be applied to your IT systems today.
Cybersecurity Threats and Risks to Life Sciences Companies
Watch this on-demand webinar to understand the current and emerging cybersecurity threats facing life sciences companies and their third-party providers, and how to evaluate and manage risk to protect intellectual property, data, patient privacy, and continuous regulatory compliance.
Content Orchestration
Content orchestration unifies workflows, content, and data services across GxP applications so regulated teams collaborate seamlessly while staying compliant. Learn the challenges it solves and the business outcomes it delivers.
Global UDI Database: What if a Medical Device is Discontinued?
When a medical device is discontinued, its UDI record does not disappear. Learn how a Commercial Distribution End Date works in the FDA's Global UDI Database (GUDID) and what manufacturers must do to stay compliant.
Single Sign-on Significantly Improves Security and Usability
Single sign-on (SSO) reduces password fatigue, cuts help desk costs, and strengthens security and compliance for life sciences companies. See how SSO improves usability while keeping validated cloud apps continuously compliant.
Top 10 Recurring Audit Observations at Life Sciences Companies
USDM auditors share the 10 recurring audit observations they see most often at pharma, biotech, and medical device companies — from environmental monitoring gaps to supplier qualification and cleaning validation — and how to close them before an inspector does.
Update from the FDA on CSV Changes
Watch this on-demand webinar with the FDA's Francisco Vicenty and USDM's Sandy Hedberg to understand the shift from Computer System Validation (CSV) to the risk-based Computer Software Assurance (CSA) approach — and how to apply it to your regulated systems today.
Tips for Start-Ups: How to Build a Cohesive, Integrated QMS
Watch this on-demand USDM webinar for emerging life sciences companies on building a cohesive, integrated Quality Management System (QMS) — a top-down framework aligned to ICH Q10, ISO, and FDA expectations that closes the gaps regulators find first.
Data in the Cloud Can Be 21 CFR Part 11 Compliant
Moving regulated data to the cloud doesn't mean giving up compliance. Learn how life sciences companies keep cloud applications 21 CFR Part 11 and EU Annex 11 compliant with validation, audit trails, and continuous compliance.
What’s new in Veeva Vault 22R1
Veeva Vault 22R1 went live April 22 with new platform and data model changes across Clinical, Quality, Regulatory, and Commercial. Learn what the release means for your validated systems and how USDM Cloud Assurance keeps you compliant.
Accelerate Your Journey to the Cloud: Move your GxP Regulated Workloads to Microsoft Azure
On-demand webinar with Microsoft and USDM Life Sciences on accelerating the migration of GxP regulated workloads to Microsoft Azure using USDM’s Cloud Assurance — covering the shift from CSV to a continuous, risk-based compliance model across IaaS, PaaS, and SaaS.
Cellular Therapy Regulations
A practical guide to FDA cellular therapy regulations under 21 CFR Part 1271, 600, and 610 — covering reproducibility, sterility, potency testing, impurities, and the validated GMP approach these products require.
Q&A with the FDA on CSV Changes
On-demand Q&A webinar with the FDA's Francisco Vicenty and USDM's Sandy Hedberg answering life sciences industry questions on CSV changes and Computer Software Assurance (CSA).
Accelerating Cloud Content Management for Emerging Life Sciences
On-demand webinar: how pre-commercial and newly commercialized life sciences companies can adopt a cloud-first approach to regulated content management, choose the right vendor, and stay GxP compliant in the public cloud as they scale.
Google Cloud Platform for Life Sciences and Health Technology
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.
IT Systems for Emerging Life Sciences – from R&D to Commercial
Watch this on-demand webinar to learn how emerging life sciences companies move from paper to the cloud, automate GxP processes, and build scalable IT systems that carry them from R&D through commercialization while controlling cost and compliance risk.
Remanufacturing of Medical Devices, New DIs, and Software Updates
FDA's draft guidance on Remanufacturing of Medical Devices redraws the line between remanufacturing, servicing, refurbishing, and repair - with major implications for UDI, new device identifiers (DIs), and software changes. Here's how to navigate the regulatory impact.
Data Migration Guidance
A practical guide to planning and executing a compliant data migration in life sciences—covering data mapping, transformation, verification, and backout planning for regulated data moving to or within the cloud, on-premise, or between systems.
Top 5 Opportunities to Improve Compliance Maturity
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.
Seamless Content, Quality, and Compliance in the Cloud
Watch this on-demand webinar to see how life sciences companies unify content, document, training, and change management in one cloud platform while maintaining continuous GxP compliance with USDM's Unify Compliance Cloud.
Q&A: SaMD Regulations and Compliant Development Environments
Expert answers from USDM's SaMD webinar on when software is regulated as a medical device, how Computer Software Assurance (CSA) reshapes validation, and which automated testing tools keep development environments compliant.
Reimagining Medical Device Post-Market Surveillance
Watch this on-demand webinar to learn how medical device manufacturers can move post-market surveillance from a passive, complaint-driven activity to a proactive system that meets evolving global requirements and delivers better clinical and safety data.
Your IT Roadmap – Guidance for Early-Stage Life Sciences Startups
Watch this on-demand webinar to build a strategic IT roadmap for your early-stage life sciences company — aligning G&A and GxP functional needs, planning for compliance, and adapting as regulations, technologies, and business requirements evolve.
Project Management: Rules of Engagement
Strong project management starts with clear rules of engagement. Learn how operating agreements, communication norms, and a culture of accountability keep life sciences project teams aligned, on schedule, and compliant—on-site or remote.
Oracle Clinical One: Next Generation Clinical Trials with Continuous GxP Compliance
Watch this on-demand webinar to see how Oracle Clinical One unifies clinical trial data, people, and processes on one eClinical platform — and how USDM Cloud Assurance keeps that environment validated and in continuous GxP compliance.
Key differences in the requirements for SFDA UDI and US & EU UDI
Manufacturers with U.S. and EU UDI-compliant medical devices face new requirements under Saudi Arabia's SFDA MDS-G34 guidance. Learn the key differences across the U.S., EU, and SFDA Unique Device Identification systems and what changes you need for SAUDI-DI compliance.
Q&A: UDI Registration in EUDAMED
Expert answers on UDI registration in EUDAMED — SRNs for legacy MDD vs. MDR devices, national requirements in Finland and the Netherlands, GDSN data, accessories, Certificates of Free Sale, and M2M vs. manual submission.
Are You Ready for the Veeva 21R3 Release?
The Veeva 21R3 release brings Email to Vault, Vault Mobile, and Google Drive integration. Learn how USDM helps life sciences teams adopt these features while keeping Vault validated and continuously compliant.
An Introduction to Computer System Validation
Watch this on-demand webinar for a clear introduction to Computer System Validation (CSV) in life sciences — what it is, why the FDA and global health authorities require it, which GxP systems it applies to, and how to plan an audit-ready CSV approach.
Q&A: How to Maximize Your GxP Use of the Public Cloud
Expert answers from USDM's webinar on running GxP workloads in the public cloud: multi-cloud strategy, the Unify Public Cloud (UPC) methodology, validation, SDLC and Agile, RPA vs. AI, and leveraging SaaS vendor documentation while staying continuously compliant.
Will Your Company Be Ready for the Next Regulatory UDI Database?
As more countries finalize Unique Device Identification (UDI) regulations, new regulatory UDI databases follow. Learn why a single global superset of data is the smarter way for medical device manufacturers to manage GUDID, EUDAMED, and beyond.
Minimize Risk and Maintain Compliance on Veeva with USDM Cloud Assurance
Watch this on-demand webinar to learn how USDM certified Veeva experts keep your Veeva GxP systems in a validated state with Cloud Assurance and modernize your CSV approach using the FDA's computer software assurance (CSA) methodology.
Simplifying Regulated, GxP Business Processes in ServiceNow
Watch this on-demand webinar to see how ProcessX, an intelligent, fully validated GxP process automation platform Built on Now, helps pharma, biotech, and medical device companies automate regulated business processes in ServiceNow while staying in a continuous state of validation.
Benefits of Pharmaceutical Serialization
Pharmaceutical serialization supports DSCSA compliance and protects patients and brands by authenticating products, improving supply chain visibility, and enabling precise recalls. Learn the benefits and how USDM helps.
Another Regional UDI Database: Singapore's UDI Implementation
Singapore's HSA UDI system aligns to IMDRF principles but diverges from U.S. rules on convenience kits and software UDIs. Here's what device makers must submit to the SMDR and Class A database, and how to manage the data.
If a CRO is Managing My Clinical Trial Data, What are My Validation Responsibilities?
If a CRO hosts and manages your clinical trial data, the CRO is responsible for a validated content management solution, but the sponsor still owns vendor oversight, qualification, and audit-readiness. Here is how to split those validation responsibilities.
The Cannabis Industry: Compliance and Enforcement in an Ever-Changing Regulatory Environment
How the FDA and state regulators are tightening compliance and enforcement for cannabis and CBD companies, and how to align your quality, IT, and validation strategy early to stay competitive on the path to commercialization.
The Evolving Global UDI Landscape
From a 2002 idea to a globally recognized standard, Unique Device Identification (UDI) now spans the US GUDID, EU MDR/IVDR, and beyond. Explore how the global UDI system is reshaping medical device traceability, safety, and regulatory harmonization.
Top 10 Reasons Life Sciences Organizations Should Move to the Cloud
Discover the top 10 reasons life sciences organizations are moving to the cloud — from built-in compliance and lower cost of ownership to scalability, security, and faster validation of regulated systems.
Data Science and Data Analytics in the Life Sciences Industry
Discover how data science, machine learning, and data analytics are reshaping life sciences—accelerating personalized medicine, clinical trials, and drug discovery for faster, more accurate results.
2022 Trends in Life Sciences
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.
An Open Letter to Medical Device Regulators
A veteran of FDA's UDI program lays out the unresolved regulatory concepts, database conflicts, and harmonization gaps that still stand between today's fragmented Unique Device Identification rollouts and the globally harmonized UDI System the industry was promised.
The Direct Marking of Medical Devices in the U.S. and Europe
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.
Using PTC's ThingWorx Solution in a GxP Regulated Environment
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.
Q&A: How to Comply with Saudi Arabia UDI Requirements
Practical answers to medical device manufacturers' top questions on complying with Saudi Arabia's UDI requirements — SAUDI-D database submission, SFDA labeling, GS1 codes, and class-based compliance deadlines.
UDI Data Quality Lessons for Medical Device Supply Chain Resilience
UDI data quality, GUDID maintenance, and global device traceability help medical device teams improve supply chain visibility and inspection readiness.
Start here
Put AI to work in life sciences — with the right guardrails underneath.
Start with a structured AI Readiness Assessment: fixed-fee, executive-ready, and built to surface the highest-value workflows first.
- Workflow inventory and risk classification
- Business value and readiness scoring
- FDA CSA + EU AI Act + ISO 42001 gap analysis
- Prioritized 90-day roadmap by impact, risk, and effort