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Where Glean Fits in the Enterprise AI Stack
A practical look at how Glean fits into the enterprise AI ecosystem as a governed work AI layer across knowledge, permissions, assistants, agents, and workflows.
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.
Trusted to Do Their Part: The Future of USDM Cloud Assurance
The USDM Cloud Assurance team explains how continuous evidence, attestable reasoning, calibrated autonomy, and human attestation shape trust for AI-bearing regulated software.
21 CFR Part 11 Compliance: A Practical Guide for Life Sciences Companies
Learn how to achieve 21 CFR Part 11 compliance with secure electronic records, audit trails, eSignatures, and validation best practices for life sciences.
Validation Lifecycle Management: How Life Sciences Teams Stay Compliant Without Slowing Down
Validation lifecycle management helps life sciences organizations streamline compliance, reduce manual effort, and maintain audit-ready systems across implementation, change control, and ongoing operations.
USDM Cloud Assurance: Continuous GxP Compliance for Modern Life Sciences Systems
Learn how USDM Cloud Assurance helps life sciences companies maintain continuous GxP compliance, automate validation, reduce release-management burden, and stay audit ready across cloud systems.
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.
Agents in GxP Workflows: How to Govern Claude Without Freezing Innovation
Learn how life sciences organizations can govern Claude-powered agents in GxP workflows with bounded autonomy, validation planning, audit evidence, and human oversight without slowing AI innovation.
Claude for Life Sciences Regulated Workflows
USDM explains how Anthropic Claude can support regulated life sciences workflows when teams define intended use, governed context, human review, validation, and inspection-ready evidence.
Claude Cowork for Life Sciences: From Chatbot to Governed Work Partner
USDM explains how life sciences teams can evaluate Claude Cowork as a governed work partner, not an unmanaged chatbot, with clear intended use, human review, and audit-ready controls.
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.
Human-in-the-Loop Claude Prompts for Regulated Teams
Prompt patterns for regulated life sciences teams using Claude: frame intended use, ground responses in approved sources, require uncertainty handling, and preserve human review evidence.
Layer 0-5: A Life Sciences Operating Model for Claude Adoption
A six-layer operating model for adopting Claude in regulated life sciences — from intended use and governed context through connectors, skills, agents, and evidence-based governance. Start with structure, not demos.
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.
Third-Party Risk Management in Life Sciences: How to Strengthen Vendor Oversight in a Regulated Industry
Learn why third-party risk management in life sciences now requires continuous monitoring, regulatory alignment, and stronger vendor governance across cyber, quality, and operational risk.
Work AI for Life Sciences: Why USDM Chose Glean
Why USDM chose Glean as a Work AI partner for life sciences — enterprise search, permission-aware knowledge, governed connectors, and a practical path from AI intent to regulated impact.
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.
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.
AI Governance for Life Sciences: The Enterprise Framework for Compliant, Scalable AI
AI governance for life sciences. FDA and EU AI Act readiness, GxP validated systems, and ISO 42001 guidance for compliant, scalable AI.
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.
Agents Without Owners: What RSA 2026 Revealed About the Agentic AI Governance Gap
RSA 2026 revealed a critical gap: AI agents are deploying faster than governance structures can track them. This analysis covers the agentic AI governance gap, new identity categories, attack surfaces, and what life sciences organizations must do now.
Is Your Veeva Vault Operating Model Ready for AI?
Maximize your Veeva Vault investment and safely adopt AI in GxP workflows. Download our white paper to learn how to build an AI-ready operating model.
Is Your Veeva Vault Delivering the Value You Paid For?
How to assess whether your Veeva Vault investment is delivering its full value — configuration maturity, adoption gaps, compliance alignment, and optimization strategies for life sciences organizations.
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.
UDI and FDA’s New QMSR Inspection Process
How the FDA's new QMSR inspection process and UDI requirements affect medical device companies — what changed, what to prepare for, and how to align quality management systems for the new regulatory framework.
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.
AI in Life Sciences: 47 Use Cases for Quality, Regulatory, Clinical, and Manufacturing Teams
Explore 47 inspection-ready AI use cases across Quality, Regulatory, Clinical, Manufacturing, and more — with quantified outcomes and governance frameworks for life sciences leaders.
Manual Workflows Are Costing Millions—Here’s Why They Persist and How Leading Companies Are Eliminating Them
Manual GxP IT workflows are quietly costing life sciences companies an estimated $1.2M-$1.5M a year through duplicated work between IT Quality and IT Operations. Learn why automation alone hasn't closed the gap and how a shared-context, GxP-routed architecture eliminates the IT Quality Information Vacuum in 2026.
AI-Enabled QMS: How Deviation and CAPA Workflows Are Changing in 2026
AI-enabled QMS in life sciences: how embedded AI is accelerating deviation triage, CAPA documentation, and root cause analysis inside validated workflows.
Organizational Change Management for Life Sciences Companies
Traditional organizational change management breaks down when AI enters GxP environments. Learn why life sciences OCM must evolve and how compliance-integrated, workflow-embedded adoption drives durable change.
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.
The New Digital Trust Crisis in Life Sciences: 5 Risks You Can’t Ignore in 2026
The 5 digital trust risks reshaping life sciences in 2026 — AI governance gaps, cloud validation debt, third-party risk, overextended security leaders, and audit exposure — plus the operating model to fix them.
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.
Life Sciences Cybersecurity: Building a Trusted Partner Ecosystem
Learn how life sciences cybersecurity programs can strengthen vendor oversight, reduce third-party risk, govern AI-enabled partners, and build an inspection-ready partner ecosystem with continuous assurance.
GxP Managed Services: How Hybrid Teams Accelerate Digital Transformation in Life Sciences
Learn how GxP Managed Services help life sciences companies close talent gaps, scale AI and cloud programs, and accelerate compliant digital transformation with hybrid delivery teams. Learn how GxP Managed Services help life sciences companies close talent gaps, scale AI and cloud programs, and acce
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.
Modernizing TPRM for an AI-Driven Ecosystem: What Good Looks Like in 2026
How life sciences organizations modernize third-party risk management for AI vendors — continuous monitoring, AI-specific risk criteria, supply chain oversight, and building TPRM programs that scale with the AI ecosystem.
USDM Life Sciences Summit 2026
Learn how to advance AI, automation, and compliance in life sciences at the 2026 USDM Summit focused on digital trust and intelligent transformation.
EUDAMED Has Landed – What It Means for You, Now
Watch Jay Crowley explain what the EUDAMED mandatory-use milestone means for MDR/IVDR compliance, UDI data readiness, and medical device operating models.
FDA AI Guidance 2025: What Life Sciences Must Do Now
The FDA has entered its AI enforcement era. This comprehensive guide covers the January 2025 draft guidance, what life sciences companies must do now, a 10-point GxP readiness checklist, and how to operationalize AI compliance.
How to Leverage USDM's Vendor Audit of Oracle Supply Chain Management Cloud
Learn how USDM's independent vendor audit of Oracle Supply Chain Management Cloud and the Vendor Assurance Report let life sciences teams leverage Oracle's validation evidence to cut testing burden the FDA's least-burdensome, risk-based way.
ETM.AI: The AI-Enabled Digital Enterprise Trace Matrix
ETM.AI from USDM and Oracle turns the Enterprise Trace Matrix into a digital, AI-powered GxP compliance fabric — embedded in the flow of work for audit readiness.
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.
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.
The EU AI Act Is Here: What Life Sciences Companies Need to Know Now
The EU AI Act is here. Learn what life sciences companies must do now to ensure compliance, avoid penalties, and stay ahead in a rapidly evolving regulatory landscape.
EUDAMED Compliance: Your Most Pressing Questions—Answered
Expert answers to the most pressing EUDAMED compliance questions—UDI registration deadlines, IVDR and MDR timelines, Access Point setup, and how to avoid costly pitfalls before the January 2026 deadline.
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.
Oracle Fusion to Redwood Migration Guide: Timeline, Strategy, and Best Practices
A compliance-first guide to migrating from Oracle Fusion to the Redwood UX: Oracle's 2025-2026 rollout timeline, an 8-step migration framework, and GxP best practices for life sciences teams.
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.
EUDAMED Challenges for Medical Device Manufacturers: Future-Proof Your 2025 Compliance Strategy
Discover how to streamline EUDAMED compliance and UDI registration. Learn from USDM & BYRD Health before the 2026 deadlines hit.
Navigating ICH E6(R3) with Confidence – A New Standard for IT Governance in Clinical Research
Join our webinar to discover how USDM’s CRO Assurance simplifies compliance with the new ICH E6(R3) sponsor oversight requirements.
Oracle Health Breach: What Life Sciences Cybersecurity Leaders Need to Know—and Do—Now
Oracle Health breach exposes life sciences to third-party cybersecurity risk. Learn what compliance and IR leaders must do now to contain exposure.
Reimagining Biotech and Pharma: The Rise of Agentic AI and Intelligent Workflows
Discover how agentic AI and intelligent workflows can accelerate clinical, regulatory, quality, and operational transformation in biotech and pharma while preserving governance, validation, 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
Learn how life sciences teams can connect asset data, APM, predictive maintenance, and AI to improve uptime, compliance visibility, and operational execution.
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
Join industry thought leaders on Feb 11 for our annual, virtual event. Discover AI, automation, and data strategies to drive innovation & compliance in life sciences.
Transformative Outcomes in Life Sciences
Discover how PTC ThingWorx, IoT, AI, digital twins, and connected GxP operations can improve quality, reduce downtime, strengthen data integrity, and support compliant transformation.
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 learn how the CloudSure ecosystem, uniquely designed for the life sciences industry, empowers your organization to accelerate compliance.
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.
GxP Training in Today’s Regulatory and Technology Landscape
How life sciences organizations modernize GxP training programs — advanced technology, risk-based approaches, ROI optimization, and building compliance culture that keeps pace with regulatory and AI-driven change.
LLMs and Cybersecurity Standards in Life Sciences
Learn how STRIDE, the OWASP LLM Top 10, and NIST AI 100-1 secure large language models in life sciences. See how to apply these standards to a gene prioritization workflow and stay compliant with HIPAA and 21 CFR Part 11.
Modernize Your Audits and Compliance with Tech Innovations
See how GenAI, AR/VR, IoT, and RPA modernize life sciences audits—improving compliance accuracy, lowering costs, and enabling proactive, continuous risk management.
Good Automated Manufacturing Practice vs. Computer Software Assurance
Compare GAMP 5 and Computer Software Assurance (CSA) for life sciences validation. Learn how CSA modernizes GAMP 5 with risk-based critical thinking to make validation more efficient without compromising quality or compliance.
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.
Q&A: Ensuring AI Compliance and Maximizing the Value of Your GxP Technologies
Answers to the most common questions about AI compliance in GxP environments — from validation strategy and governance frameworks to maximizing the value of regulated technology investments.
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.
Cybersecurity in Medical Devices: How Did 524B Come About?
Trace how Section 524B of the FD&C Act came to be—from early implantable device hacks through WannaCry, URGENT/11, and SweynTooth—and what its mandatory premarket cybersecurity requirements mean for medical device manufacturers.
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.
AI, Adversarial Attacks, and Insider Threats in Life Sciences
Adversarial attacks and insider threats threaten AI and GenAI systems across the life sciences model lifecycle. Learn how NIST AI RMF risk assessments, GxP-aligned controls, and AI governance protect clinical, quality, and regulatory decisions.
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.
Q&A: Mandatory Use of EUDAMED Now Starting Q1 2026
The EUDAMED timeline moved up: mandatory use of the Device Registration and UDI module now starts Q1 2026. Get answers on legacy device registration, post-market surveillance, AS4, and UDI-DI triggers for medical device manufacturers.
Computer System Validation Services: From CSV Burden to CSA-Ready Innovation
Modernize computer system validation services with a CSA-ready, risk-based operating model for cloud, SaaS, AI-enabled workflows, automation, and audit-ready GxP compliance.
Mandatory Use of EUDAMED Now Starting Q1 2026
Technical considerations and guidance for managing UDI data to meet the deadline. Learn more in this webinar!
Deepfakes and Financial Fraud
Deepfake technology is fueling a surge in financial fraud, identity theft, and impersonation attacks. Learn how deepfakes are created, where they threaten life sciences organizations, and the verification controls and cybersecurity strategies that mitigate the risk.
GxP Primer: Where Do Good Practices Come From and Why Do We Need Them?
Global health regulators home in on critical requirements for life sciences organizations. Learn more about GxP in our latest blog!
Ensuring AI Compliance and Maximizing the Value of Your GxP Technologies
Sorcero, Google, & USDM developed a purpose-built AI solution that helps life sciences organizations successfully adopt AI & mitigate risk.
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.
A Comprehensive Guide to Responsible AI for Life Sciences
Discover the importance of purpose-built AI framework & solution that helps life sciences organizations successfully adopt AI & mitigate risk.
Implementing a Corporate Chargeback System for AI Citizen Development
Learn how a corporate chargeback system fairly allocates the costs and benefits of AI citizen development across business units, with a step-by-step model for transparent, accountable AI investment in life sciences.
AI Governance and Citizen Development for GenAI in Life Sciences
Generative AI (GenAI) technologies will accelerate drug discovery, drive significant advancements in personalized medicine & more!
Proof of Concept and Pilot Projects: Essential Steps in AI Technology Development
Compare proof-of-concept and pilot projects in AI development for life sciences, including the scope, resources, risk, and validation each stage requires to move toward a compliant, full-scale rollout.
Best Practices for Virtual Audits and Regulatory Inspections
Learn how to run inspection-ready virtual audits with secure evidence exchange, remote walkthroughs, vendor qualification controls, and defensible GxP documentation.
Elevating Life Sciences with the Cloud Assurance Certified Program
Discover how USDM's Cloud Assurance Certified program ensures compliance, reduces risks, and drives innovation for life sciences organizations.
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.
Top 10 Considerations for Implementing a GxP Content Management System
A practical 10-point framework for selecting and implementing a GxP-compliant content management system that strengthens regulatory compliance, automates workflows, and readies your content for GenAI.
Fast-Track Your Journey to Commercialization
Fast-track commercialization in life sciences with USDM's GxP expertise, IT strategies, and QMS frameworks for compliance, efficiency, and success.
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
Life sciences organizations are eager to make use of their vast amounts of data. Explore five trends that are fueling their efforts.
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.
6 Considerations for Reducing Your IT Cost of Ownership
A practical guide to the six cost drivers life sciences IT leaders should weigh—acquisition, operations, maintenance, compliance, upgrades, and replacement—to lower total cost of ownership without sacrificing GxP compliance.
Lessons Learned in the On-Going RPA Journey
How USDM's robotic process automation framework turns reusable components, risk-based testing, and continuous feedback into faster, validated RPA for GxP environments.
Anticipating Regulatory Compliance for Artificial Intelligence in Life Sciences
Learn how to prepare AI systems, vendors, data, validation evidence, and lifecycle controls for emerging FDA and global regulatory expectations in life sciences.
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
Learn how to strengthen eSignature security, identity assurance, audit trails, encryption, AI-enabled workflows, and data integrity controls in regulated life sciences.
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.
Using AI to Help Ensure Compliance while using eSignatures
See how AI and machine learning strengthen secure, compliant eSignature workflows in life sciences — supporting 21 CFR Part 11 and EU Annex 11 through behavior analysis, audit trails, and predictive monitoring.
How AI is Transforming eSignature Workflows in Life Sciences
How AI transforms eSignature workflows in life sciences — intelligent routing, document automation, compliance verification, and the orchestration that turns signature collection from administrative burden into operational accelerator.
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.
USDM Life Sciences Summit 2024
Explore AI in life sciences with USDM’s on-demand event. Learn about AI regulations, use cases for workflow automation, and governance frameworks for compliance.
Best Practices for Complaint and Adverse Event System Implementation
Best practices for implementing complaint and adverse event systems in life sciences — intake design, triage automation, regulatory reporting, signal detection, and validation strategy for safety surveillance platforms.
Outsource Your Complaint and Adverse Event Management
Outsourcing complaint and adverse event management gives life sciences companies qualified post-market surveillance specialists, investigators, engineers, and clinicians to resolve complaints faster and stay ahead of regulatory citations.
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.
Overcome Workforce Challenges with Augmented Reality
See how augmented reality helps life sciences manufacturers close skills gaps, speed new-hire training, and capture expert knowledge—while staying compliant through CSA and validation.
Be Confident and Ready for Your Next Regulatory Inspection
Reduce audit anxiety and walk into your next FDA or GxP regulatory inspection prepared. Learn how a mock audit gets your people, processes, and technology inspection ready.
Time and Cost Savings with Cloud Assurance Automation
Explore the advantages of automating workflows and testing for your regulated GxP systems. Learn more today!
Automate Now | Best Practices for GxP Systems
Join our webinar to get guidance for automated testing, IT change management, and artificial intelligence (AI) to decrease risk and increase operational efficiency. Register Now!
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.
Why Integrated GxP Compliance is More Progressive than Traditional Managed Services
Traditional managed services chase year-over-year savings, but integrated GxP compliance ties outcomes to value—scaling with your SaaS portfolio, simplifying compliance, and accelerating your journey from molecule to market.
Integrated GxP Compliance
Discover how USDM’s Integrated GxP Compliance simplifies life sciences operations. Learn about digital quality, automation, and innovation-driven compliance.
Discover a next-generation business model that drives tangible business outcomes
Learn how outcome-based, next-generation managed services models for integrated GxP compliance help life sciences Quality teams proactively minimize risk, accelerate time-to-market, and turn compliance into measurable business value.
Integrated GxP Compliance for the Life Sciences Industry
Embrace the integrated GxP compliance approach to achieve remarkable cost savings through innovative. Learn more in this whitepaper!
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.
Understanding FD&C 524B – Cybersecurity Requirements for Medical Devices
Learn why cybersecurity matters for medical devices and 9 Steps to meet FD&C 524B requirements. Download Now!
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
Clarify validation responsibilities for SaaS and cloud systems, leverage vendor evidence, apply CSA principles, and close GxP validation gaps with risk-based controls.
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.
Good Manufacturing Practices (GMP): Ensuring Quality in Manufacturing Processes
Good Manufacturing Practices (GMP) keep pharmaceutical, food, and medical device products safe, consistent, and compliant. Learn what GMP covers, why it matters, and how USDM Life Sciences helps you implement and sustain it.
An Update on the FDA’s UDI and GUDID Compliance Requirements
ON-DEMAND WEBINAR: An update on the FDA’s requirements and notification activities and aims to answer many of the incoming questions our UDI consultants have received recently.
Continued Confusion and Misinformation about UDI Implementations
UDI requirements for the US and EU are similar but not identical, and confusion persists. Learn the dual purpose of Unique Device Identification, the EU MDR UDI deadlines that have not changed, and how to build a scalable, compliant UDI program.
Lessons from the USDM Cloud Assurance Box GxP Automated Testing Tool
How USDM built an Automated Testing Tool (ATT) for Cloud Assurance to test Box GxP daily at the UI level - lessons learned on automated regression testing, CSA, and keeping cloud systems in a state of compliance.
Strategic IT Roadmap for Life Sciences
A strategic IT roadmap aligns your life sciences technology investments with business milestones, regulatory requirements, and GxP needs. Learn how USDM builds value-driven, compliant IT roadmaps for emerging and global life sciences companies.
Managing GxP Workflows & Continuous Cloud Compliance with ProcessX and ServiceNow
Watch how ProcessX on ServiceNow helps life sciences teams automate GxP workflows, maintain 21 CFR Part 11 controls, and scale regulated processes with continuous compliance.
Simplify GxP Quality Assurance
ON-DEMAND WEBINAR: Managing your eQMS shouldn't be complex. ZenQMS and USDM keep it simple.
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
Product Portfolio Manager, Alex Sanchez goes over the regulated use cases for NetSuite and how USDM solves compliance issues. Watch today!
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.
Manual Processes Result in More Errors
Manual testing invites human error, slows time to discovery, and strains compliance. See how process automation, computer software assurance, and continuous validation help life sciences teams improve quality and stay audit-ready.
Emerging Life Sciences Virtual Event
Fast-track your journey from R&D to commercialization with guidance from thought leaders across the industry.
2023 Technology Trends in Life Sciences
We examined five technology trends that are significantly impacting the life sciences industry in 2023. Download the whitepaper today!
Q&A: UDI Beyond Borders
Expert answers on managing Unique Device Identification (UDI) across global markets—covering GUDID and EUDAMED change notifications, what triggers a new device identifier, market-specific DIs, and easing the burden of multiple regulatory requirements.
Applications of Blockchain Technology Within Pharmaceutical Supply Chain and Quality Management Systems
Learn how blockchain can support pharmaceutical supply chain traceability, chain of custody, data integrity, anti-counterfeit controls, and QMS use cases in regulated life sciences.
USDM Life Sciences Summit 2023
Simplify, automate, and optimize your GxP technologies and business processes with guidance from thought leaders across the industry.
Agile Compliance for High-Quality GxP Software
How life sciences teams apply agile development practices within GxP compliance frameworks — iterative validation, risk-based testing, continuous compliance, and quality-by-design for regulated software.
Validation is a Team Sport
Computer software validation is a team effort, not a one-time checkbox. Learn the cross-functional roles, lifecycle approach, and CSV/CSA best practices that keep life sciences GxP systems compliant and fit for intended use.
Compliant IT Strategies On-Demand Webinar
Compliant IT strategies for early-stage biotech and pharmaceutical companies, helping you develop an IT strategy from pre-clinical through commercialization.
What is Compliance as a Code?
Compliance as Code (CaC) tools like Azure Blueprints and AWS Conformance Packs configure governance controls, but configuration alone does not equal regulatory compliance. See how USDM validates and continuously qualifies your cloud environment.
Computer Software Assurance (CSA) Draft Guidance Webinar
Watch our experts, including Francisco Vicenty, Program Manager, Case for Quality - FDA, discuss changes & implications impacting life science companies.
The Benefit of Electronic Signatures for your Startup Life Sciences Company
Paper-based processes and wet signatures quietly slow emerging life sciences companies and inflate costs. Learn how a digital-first, 21 CFR Part 11-compliant eSignature approach accelerates R&D, clinical studies, and time to market.
UDI Beyond Borders
12th annual UDI Conference will be hosted by USDM Life Sciences and moderated by Jay Crowley, the original developer and author of the FDA’s UDI requirements.
Critical vs. Non-Critical GxP Applications
Learn how to classify critical vs. non-critical GxP applications, sequence a risk-based cloud migration, and maintain validation quality and business continuity throughout the transition.
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.
Interim CIO Advisory Services for Emerging Life Science Companies
Emerging life sciences companies can accelerate compliance and growth with a fractional, interim CIO who aligns IT strategy, quality, and regulatory execution without the cost of a full-time hire.
Global UDI Data Management – The New Paradigm
Currently, multiple regulators have or are launching national UDI Databases (US, EU, SFDA, NMPA, KFDA, HSA). Other regulators are following close behind.
Automate Validation Across Your GxP Tech Stack
We discuss considerations for managing GxP cloud compliance, automating validation and regression testing, evolving your IT infrastructure & more!
Cloud 101: Part 4 – Automation in the Cloud
Cloud automation streamlines how life sciences IT teams manage cloud infrastructure and applications. Learn how automated, continuous testing keeps GxP systems compliant as vendors push frequent updates.
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: This webinar will addresses forward-thinking validation and continuous compliance considerations for modern cloud technologies.
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.
Adapting Computer System Validation to Accommodate Evolving FDA Guidance
How life sciences teams can move from documentation-heavy computer system validation (CSV) to the FDA-encouraged, risk-based Computer Software Assurance (CSA) approach—more testing, less paperwork—without waiting for the final guidance.
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.
How to Align your CSV Program with the FDA’s CSA Approach
Learn how to align your Computer System Validation (CSV) program with the FDA's Computer Software Assurance (CSA) approach — a risk-based path to optimize validation, reduce documentation burden, and strengthen patient safety and product quality.
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.
Most Misunderstood and Misapplied UDI Requirements
A clear breakdown of the most misunderstood UDI rules—Direct Marking under FDA 801.45(a), what "reprocessed before each use" really means, and why a device's label is a regulatory concept, not a sticker.
Demystify FDA Compliance for Public Cloud Workloads in Life Sciences
Explore best practices for FDA-compliant cloud adoption in life sciences. Learn about workload analysis, compliance management, and secure cloud strategies.
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.
Five Tips for Successful Veeva Implementation
Five proven tips for a successful Veeva implementation in life sciences, from maximizing out-of-the-box functionality to single-plan program management, validation, and organizational change.
How Do Life Science Companies Qualify Vendors and Software?
Most automated systems life sciences companies rely on come from third-party vendors as off-the-shelf (OTS) software. Learn how to audit vendor methodologies, validate OTS software, and qualify the right partners for GxP use.
Is There a Checklist for GCP Audits?
GCP audit checklists are widely available, but the strongest ones map to ICH E6 and the applicable FDA clinical research regulations. USDM auditors explain what a GCP audit checklist should cover and why to build it into your QA process before an audit notice arrives.
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
On-demand webinar topic: Cannabis: Compliance in a Rapidly Changing Industry.
Challenges with EU MDR and IVDR Compliance
On-demand webinar topic: Challenges with EU MDR and IVDR Compliance. With less than a year to go, is your company ready?
EU MDR Date of Application Readiness
Explore strategies for EU MDR compliance. Learn near-term and long-term steps, EUDAMED requirements, and key deadlines in our on-demand webinar and guide.
Evolving Global UDI Product Data Requirements
Explore UDI challenges for device manufacturers. Learn to manage regulatory, commercial, and patient safety requirements globally in this on-demand webinar.
How to Get Results on Regulated Projects with Virtual Teams
Learn best practices for managing virtual workforces in regulated environments. Maintain business continuity and compliance with expert insights and tools.
How to Comply with Saudi Arabia UDI Requirements
Learn how to comply with SFDA UDI requirements for medical devices in Saudi Arabia. Understand deadlines, database submissions, and labeling guidelines.
How to Maximize Your GxP Use of the Public Cloud
Learn how to scale GxP workloads in the public cloud for life sciences. Explore migration strategies, compliance, and advanced analytics for digital transformation.
SaMD Regulations and Compliant Development Environments
On-demand webinar topic: SaMD Regulations and Compliant Development Environments with USDM Life Science experts.
UDI Registration in EUDAMED – Why and How to Use It Now
Learn about EUDAMED's new UDI Database module, MDR compliance, actor registration, and future steps in this expert-led discussion. Watch the webinar now!
Virtual Audits and Inspections
Explore how virtual audits streamline vendor qualification and regulatory compliance. Learn about technologies enabling efficient remote assessments.
Work Faster and Smarter in Biotech Quality Management
Discover how Box, ComplianceQuest, and USDM simplify quality management with bundled solutions. Save time, reduce costs, and streamline workflows.
An Introduction to Computer Software Assurance
On-demand webinar topic: An Introduction to Computer Software Assurance.
Cybersecurity Threats and Risks to Life Sciences Companies
On-demand webinar topic: Cybersecurity Threats and Risks to Life Sciences Companies.
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.
Validating SharePoint for Life Sciences Regulated Environments
Learn how to validate SharePoint for GxP-regulated life sciences environments — from scoping intended use to qualifying security, audit trails, versioning, and workflows so SharePoint can serve as a compliant EDMS or quality management system.
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.
DevOps Framework
A GxP DevOps framework lets life sciences teams automate code development and deployment with compliance and security built into the pipeline. Learn the five maturity levels, common challenges, and the business outcomes of continuous validation.
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.
Rapid Application Migration
Rapid application migration—often called "lift & shift"—is the fastest, most cost-effective way for life sciences companies to begin a compliant cloud journey by re-hosting GxP applications without re-engineering them.
Embracing the Fundamental Change Brought on by Digital Transformation
Digital transformation in life sciences is more than "moving to the cloud"—it reshapes how your organization operates. Learn how to adopt new technologies while maintaining continuous GxP compliance and maximizing ROI.
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.
Oracle Validation and Assurance Virtual Roundtable
On-demand webinar topic: Oracle Validation and Assurance Virtual Roundtable.
Update from the FDA on CSV Changes
On-demand webinar topic: Update from the FDA on CSV Changes. Learn directly from the FDA on the CSV guidance changes.
Tips for Start-Ups: How to Build a Cohesive, Integrated QMS
Tips for Emerging Life Science Companies: How to Build a Cohesive, Integrated QMS and how to identify areas in your QMS that may need improvement.
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 topic: Accelerate Your Journey to the Cloud: Move your GxP Regulated Workloads to Microsoft Azure.
What are Key Performance Indicators for a Life Sciences Project?
Learn which key performance indicators (KPIs) matter most for life sciences projects — from on-time delivery and budget management to quality, scope, and organizational change management — and how to define and measure success in regulated environments.
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.
Standard Operating Procedures (SOPs) – Best Practices for Emerging Life Sciences Companies
Blog article topic: Standard Operating Procedures (SOPs) – Best Practices for Emerging Life Sciences Companies.
Q&A with the FDA on CSV Changes
Question & Answer session with the FDA on CSV changes. Learn from the FDA & our subject matter experts today!
Accelerating Cloud Content Management for Emerging Life Sciences
On-demand webinar topic: Accelerating Cloud Content Management for Emerging Life Sciences.
Cloud 101: Part 2 – Vendor Management and Scaling to the Cloud
Cloud 101 Part 2 covers how life sciences teams select and qualify cloud vendors, build the right SLAs, and scale compliantly to the public cloud while managing risk.
Cloud 101: Part 1 – Cloud Service Models
A clear introduction to IaaS, PaaS, and SaaS for life sciences. Learn how each cloud service model maps to your infrastructure, IT resources, cost, and compliance needs.
Google Cloud Platform for Life Sciences and Health Technology
Learn how Google Cloud and USDM help life sciences teams build compliant cloud programs with GxP controls, DevOps evidence, data governance, and cloud assurance.
IT Systems for Emerging Life Sciences – from R&D to Commercial
On-demand webinar topic: IT Systems for Emerging Life Sciences – from R&D to Commercial.
Q&A: Simplifying Regulated GxP Business Processes in ServiceNow
Practical answers on simplifying regulated GxP business processes in ServiceNow — process automation, validation strategy, change control, and continuous compliance for life sciences ITSM.
Robotic Process Automation 101
Robotic Process Automation (RPA) uses software bots to emulate how people interact with digital systems, automating routine, rule-based tasks. Learn what RPA can and can't do, GxP-related use cases, and why a mature validation strategy matters in regulated life sciences.
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.
An Introduction to Software Validation
Software validation proves a system does what it is intended to do. Learn USDM's structured approach to FDA software validation, from user specifications and risk assessment through IQ/OQ/PQ testing and maintaining the validated state.
Top 5 Opportunities to Improve Compliance Maturity
Understand compliance maturity and explore strategies for improvement. Learn how automation, cloud tech, and data-driven approaches drive innovation and compliance.
Seamless Content, Quality, and Compliance in the Cloud
On-demand webinar topic: Seamless Content, Quality, and Compliance in the Cloud.
Why You Should Consider Outsourcing Your Cloud Vendor Qualification
Download USDM’s white paper on outsourcing cloud vendor qualification for regulated life sciences teams, including vendor assurance, SLA review, audit readiness, and ongoing cloud compliance.
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
On-demand webinar topic: Reimagining Medical Device Post-Market Surveillance.
The Origins of UDI
A firsthand account of how the FDA's Unique Device Identification (UDI) System regulation came to be — and why accurate, consistent device identification still matters for digital health, supply chain integrity, and patient safety.
GCP Investigators: Do Regulations Require a CV to Be Updated Every Two Years?
FDA regulations do not mandate a two-year CV refresh for clinical investigators, but GCP requires documented qualifications. Here is what sponsors and sites should actually do.
Your IT Roadmap – Guidance for Early-Stage Life Sciences Startups
Learn how to create a strategic IT roadmap for early-stage life sciences companies. Address functional needs, GxP compliance, and adapt to evolving demands.
5 Tips to Drive Your IT and Compliance Strategy for IT Leaders in Emerging Life Sciences
A practical 5-step playbook for IT leaders at emerging life sciences companies: assess your current state, prioritize critical GxP systems, build an IT and compliance roadmap, plan for the cloud, and work smart with validation-as-a-service to accelerate the path to commercialization.
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
On-demand webinar topic: Oracle Clinical One: Next Generation Clinical Trials with Continuous GxP Compliance.
Computer Software Assurance (CSA) Guidance
Learn how Computer Software Assurance modernizes software validation with risk-based testing, critical thinking, leveraged evidence, quality improvement, and patient-safety focus.
FAQ: CSV, CSA, and Why the Paradigm Shift
Answers to the most common questions about the FDA's CSV to CSA paradigm shift — what changes, what stays the same, how to transition, and the practical impact on life sciences validation programs.
Top Cloud Insights for Life Sciences
A curated starting point for life sciences cloud questions, spanning regulatory compliance, audit and assessment, GxP validation, and digital transformation in the public cloud.
Top CSA Insights
Explore USDM's top Computer Software Assurance (CSA) insights — FDA guidance on CSV changes, a risk-based approach that puts critical thinking ahead of documentation, and practical resources to help regulated life sciences teams adopt CSA.
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.
Information System (IS) Compliance Health Check
Assess your cloud readiness, IS compliance maturity, and process efficiency with USDM's Information System (IS) Compliance Health Check — a people, process, and technology evaluation that builds a clear roadmap to compliance maturity.
EU MDR Date of Application Readiness Guide
The European Union (EU) Medical Device Regulation (MDR) is a new and different regulation. See what it means for your organization here!
An Introduction to Computer System Validation
On-demand webinar topic: An Introduction to Computer System Validation.
Cloud Content Management with Automated GxP Compliance Built In
Learn how Box and USDM help life sciences teams govern regulated content, automate validation evidence, support secure collaboration, and maintain GxP compliance in the cloud.
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.
Is it Acceptable to Push Back if You Disagree with a Notice of Violation or 483?
Yes, you can professionally push back on an FDA 483 or Notice of Violation, but timing and evidence matter. Learn how to challenge observations during the inspection, present objective evidence, and resolve issues before they become formal findings.
Minimize Risk and Maintain Compliance on Veeva with USDM Cloud Assurance
On-demand webinar topic: Minimize Risk and Maintain Compliance on Veeva with USDM Cloud Assurance.
Simplifying Regulated, GxP Business Processes in ServiceNow
ProcessX is an intelligent, fully validated, GxP process automation platform designed for regulated pharmaceutical, biotech, & medical device companies.
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.
Top 5 Ways to Be Successful with Salesforce and GxP
Five proven tips for running Salesforce as a compliant GxP platform in life sciences: qualify the platform, manage Salesforce's three annual releases, optimize before you migrate, start small, and stand up a centralized governance team.
Becoming a Cloud-First Company
Becoming a cloud-first company means more than moving applications. Learn how life sciences organizations build a strategy that sustains quality and compliance throughout digital transformation.
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.
USDM and DocuSign – Compliant Now, Compliant Forever
How USDM's Validation Accelerator Package and continuous release analysis keep DocuSign 21 CFR Part 11 deployments compliant now and compliant forever — getting life sciences teams live in as little as one week.
2022 Trends in Life Sciences
See what the trends are for life science companies in 2022 from our industry leading thought experts. Read more today!
Q&A: Your IT Roadmap –Guidance for Early-Stage Life Sciences Companies
Practical answers from USDM experts on building an IT roadmap for early-stage life sciences companies — covering GxP application selection, e-signatures, access management, validation testing, platform consolidation, and cloud validation staffing.
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.
Regulated GxP Workloads in the Public Cloud
Life sciences companies have lagged in their cloud and emerging technology adoption due to burdensome regulatory requirements and risk-averse culture.
Lessons in Cloud Assurance
Lessons in cloud assurance for life sciences: vendor qualification, GxP cloud validation, change control cadence, and continuous compliance with CSA.
The Direct Marking of Medical Devices in the U.S. and Europe
Download USDM’s white paper on UDI direct marking requirements for medical devices in the U.S. and Europe, including applicability, implementation, technologies, exceptions, and inspection-ready traceability.
Caution about FDA’s Most Recent UDI "Enforcement Discretion" Guidance
FDA’s UDI enforcement discretion guidance does not change the compliance date — and it excludes implants and life-supporting/life-sustaining devices. Learn which class I, unclassified, and not-classified device types must still be fully UDI compliant.
On-site and Remote Audit Best Practices
On-site and remote audits go smoother when you prepare for them deliberately. Get USDM's audit team best practices — agenda discipline, mock audits, qualified backups, and secure content management for clean, low-finding inspections.
Computer Software Assurance: What You Need to Know About the FDA's Upcoming Guidance
White paper on Computer Software Assurance: What You Need to Know About the FDA’s Upcoming Guidance.
More Medical Device Implications of Brexit
Brexit reshaped how medical devices reach the UK market. Learn the MHRA registration deadlines, UK Responsible Person rules, and the shift from CE marking to UKCA and UK(NI) marks for Great Britain and Northern Ireland.
Using PTC's ThingWorx Solution in a GxP Regulated Environment
Learn how to validate PTC ThingWorx Industrial IoT capabilities in GxP regulated life sciences environments using risk management, data integrity controls, and lifecycle governance.
Quality Management Systems for Emerging Life Sciences Organizations
Learn how a properly implemented QMS supports your organization’s strategic quality objectives. Download the whitepaper today!
Q&A: How to Comply with Saudi Arabia UDI Requirements
Blog article written from the Q&A during the How to Comply with Saudi Arabia UDI Requirements webinar.
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