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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.
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.
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.
Data Classification in Life Sciences: The Boring Work That Makes AI Possible
Most life sciences companies cannot describe what data they have, where it lives, or what can be done with it. This article presents the two-horizon framework for data classification — building from AI-safe search to full agentic AI readiness.
From Phase 3 Win to NDA: The GxP Readiness Gaps That Sink Clinical-Stage Oncology Biotechs
Clinical-stage biotechs often hit Phase 3 before discovering critical GxP gaps. Here are 5 infrastructure failures that delay NDA submissions — and how to close them.
When Your Clinical Trial Sites Go Dark: What the Stryker Cyberattack Means for Biotech and Pharma
A cyberattack on Stryker wiped systems globally—what it reveals about hidden third-party risk in clinical trials and what biotech and pharma sponsors should do now.
The Top 10 AI Use Cases Life Sciences Leaders Should Be Prioritizing Now
Discover 10 inspection-ready AI use cases transforming life sciences across Quality, Regulatory, Clinical, Manufacturing, and Safety. Learn how intelligent automation reduces compliance cost, accelerates workflows, and strengthens auditability—without increasing regulatory risk. AI use cases life sc
5 Ways AI is Transforming Clinical Trials
AI is transforming clinical trials with smarter design, faster data analysis, and improved compliance. Discover AI-powered clinical solutions with USDM. AI is transforming clinical trials with smarter design, faster data analysis, and improved compliance. Discover AI-powered clinical solutions with
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.
UDI Compliance and the Future of Medical Device Data
EUDAMED is here—avoid costly UDI mistakes. Ensure data integrity, maintain compliance, and protect market access for medical devices.
Evaluating Google Agentspace for Life Sciences
Discover 10 key factors life sciences must assess when adopting Google Agentspace for secure, compliant AI integration.
Security Over Speed: Applying J.P. Morgan’s Cybersecurity Risk Mandate to Life Sciences Vendors
Why life sciences must prioritize security over speed—and how smart TPRM strategies protect data, compliance, and patient safety.
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 cyberattacks expose sensitive data and compliance risks. Learn what life sciences companies must do now.
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
Discover how Offensive Security Testing strengthens cybersecurity in life sciences labs. Learn how to protect sensitive research data, prevent breaches, and ensure compliance.
The DM Clinical Research Data Breach: A Stark Reminder of Third-Party Risk in Life Sciences
The DM Clinical Research breach exposed 2TB of patient data, stressing the need for stronger third-party risk management in life sciences.
Third-Party Risk Management for Life Sciences
Learn how life sciences companies can manage third-party risk, ensure vendor compliance, and protect critical data with USDM’s TPRM solutions.
Seamless Compliance and Cost Savings with USDM’s Veeva-DocuSign Integration Accelerator
Learn how USDM’s Veeva-DocuSign Integration Accelerator simplifies eSignatures, reduces costs, and ensures 21 CFR Part 11 compliance for life sciences.
Cybersecurity Challenges and Solutions for Emerging Biotech Companies
Biotech and biopharma face growing cybersecurity threats. Virtual CISO services provide expert security leadership to protect IP and data. Read on.
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.
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
Discover how advanced data integration drives innovation, improves patient outcomes, and enhances operational efficiency in the life sciences industry.
Leveraging Hybrid Cloud and Integration Services in Regulated Life Sciences
Explore how hybrid cloud and integration services drive innovation, scalability, and compliance in regulated life sciences.
Metadata Management & Content Searchability in Life Sciences
In the complex and data-rich environment of life sciences, effective metadata management is not just a nice-to-have—it's a necessity.
How Secure API Management Transforms Data Exchange in Life Sciences
Discover how secure API management streamlines data exchange in life sciences while ensuring compliance with HIPAA, GDPR, and FDA standards.
Transforming Data into Actionable Insights with Tailored BI Dashboards
Drive actionable insights with tailored BI dashboards that optimize decision-making, efficiency, and strategy alignment through real-time visualizations.
Version Control & Audit Trails in Life Sciences
Version control and audit trails are two fundamental mechanisms for maintaining data integrity and accuracy. Learn best practices.
Best Practices for Managing Content in Emerging Biopharma and Regulated Life Sciences Companies
Streamline content management for emerging biopharma with best practices to ensure compliance, scalability, and operational excellence
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
A strategic data roadmap fosters growth, compliance, and innovation in life sciences by centralizing, optimizing, and scaling data management systems.
Boost Efficiency and Anticipate Trends with AI-Driven Predictive Analytics in Life Sciences
To effectively leverage AI-driven predictive analytics, life sciences organizations should consider these best practices.
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.
LLMs and Cybersecurity Standards in Life Sciences
LLMs present opportunities to advance drug discovery and development, but protecting the data being processed takes precedence.
Achieving Unprecedented Value from your Veeva Investments
Maximize your Veeva investment with USDM. Solve data silos, integration barriers, and platform complexities with tailored, compliance-ready solutions.
Data Rich and Information Poor
Unlock the full potential of your data in life sciences. USDM helps unify, govern, and analyze data to drive innovation, compliance, and smarter decisions.
How to Fulfill Expectations for Data Privacy and Security
Explore a variety of tools and services to help your organization achieve data confidentiality, integrity, and availability.
AI, Adversarial Attacks, and Insider Threats in Life Sciences
With the integration of AI comes significant security risks. Learn how to overcome attacks and threats, starting with an AI risk assessment.
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!
Top 10 Considerations for Implementing a GxP Content Management System
Discover the top 10 considerations for implementing a GxP-compliant content management system to enhance compliance, efficiency, and data management.
Good Machine Learning Practice (GMLP) for Medical Device Development: Guiding Principals
Explore the guiding principles of Good Machine Learning Practice (GMLP) and the importance of ethics, data integrity, and model transparency.
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
The growing volume and complexity of data make data management more critical than ever in the life science industry. Learn more today!
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.
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.
Best Practices for Complaint and Adverse Event System Implementation
Guidance for data management and system implementation for complaints handling. Learn more from USDM Life Sciences experts 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!
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 Laboratory Practices (GLP): Ensuring Quality and Reliability in Scientific Research
This blog delves into the fundamental aspects of Good Laboratory Practices & how it helps life sciences organizations maintain scientific rigor.
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.
Strategic IT Roadmap for Life Sciences
Information Technology (IT) is the backbone of any life sciences company and is necessary for collecting, archiving, and analyzing complex data.
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
The data your organization generates and stores can still be overwhelming to transform it into meaningful and actionable insight.
Q&A: UDI Beyond Borders
Blog article topic: Q&A from UDI Beyond Borders Webinar.
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.
Validation is a Team Sport
Blog article topic: Learn the roles and responsibilities to maintain compliance as part of a larger team.
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.
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.
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.
Data Migration
Migrating your data to the cloud provides scalability, cost effective data backup & archiving, & stronger security than traditional data centers
Cloud 101: Part 3 – Embracing the Cloud
Cloud is no longer an emerging technology. As adoption accelerates, it’s becoming a ubiquitous delivery option for all kinds of IT.
Phased Migration of Critical Applications and Databases
Phased migration of critical applications & databases addresses the move of complex, external facing GxP applications while controlling access.
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
Device manufacturers are facing complex challenges when it comes to assessing, planning, and executing UDI regulations.
Compliant Data Migration Solutions
Whatever requirements you identify, a data migration plan is essential. It is rarely a simple copy; there is almost always data mapping & complex processes.
Q&A: EU MDR Date of Application Readiness
Blog article written from the Q&A during the EU MDR Date of Application Readiness webinar.
4 Simple Steps to Ensure Data Integrity in Quality Control Labs
Blog article topic: 4 Simple Steps to Ensure Data Integrity in Quality Control Labs. See our solutions for the laboratory!
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 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!
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.
Global UDI Database: What if a Medical Device is Discontinued?
At some point in the future when a product is no longer distributed, the medical device company will need to...
Single Sign-on Significantly Improves Security and Usability
Single Sign-on Significantly Improves Security and Usability for life science companies. Learn more about the use of single sign on!
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.
Data in the Cloud Can Be 21 CFR Part 11 Compliant
USDM Life Sciences specializes in helping life sciences companies achieve and maintain continuous compliance with their cloud solutions.
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.
Accelerating Cloud Content Management for Emerging Life Sciences
On-demand webinar topic: Accelerating Cloud Content Management for Emerging Life Sciences.
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.
Data Migration Guidance
Blog article topic: Data Migration Guidance. Whatever migration requirements you identify, a data migration plan is essential.
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.
Q&A: SaMD Regulations and Compliant Development Environments
Blog article written from the Q&A during the SaMD Regulations and Compliant Development Environments webinar.
Reimagining Medical Device Post-Market Surveillance
On-demand webinar topic: Reimagining Medical Device Post-Market Surveillance.
Project Management: Rules of Engagement
Establishing rules for accountability and responsibility are critical to a project management team’s success.
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.
FAQ: CSV, CSA, and Why the Paradigm Shift
This FAQ curates many questions from our customers and attendees to our various webinars with the FDA on the CSA Guidance.
Q&A: UDI Registration in EUDAMED
Blog article written from the Q&A during the UDI Registration in EUDAMED webinar.
An Introduction to Computer System Validation
On-demand webinar topic: An Introduction to Computer System Validation.
Q&A: How to Maximize Your GxP Use of the Public Cloud
Blog article written from the Q&A during the How to Maximize Your GxP Use of the Public Cloud webinar.
Will Your Company Be Ready for the Next Regulatory UDI Database?
Blog article topic: Will Your Company Be Ready for the Next Regulatory UDI Database?
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.
Another Regional UDI Database: Singapore's UDI Implementation
Blog article topic: Another Regional UDI Database: Singapore’s UDI Implementation.
If a CRO is Managing My Clinical Trial Data, What are My Validation Responsibilities?
The responsibility is on the CRO to have a validated compliance content management solution for your content. Learn USDM's Solution!
The Cannabis Industry: Compliance and Enforcement in an Ever-Changing Regulatory Environment
Blog article topic: The Cannabis Industry: Compliance and Enforcement in an Ever-Changing Regulatory Environment.
Data Science and Data Analytics in the Life Sciences Industry
Learn how data science and machine learning transform life sciences with personalized medicine, clinical trials, and drug discovery for faster, smarter results.
Q&A: Your IT Roadmap –Guidance for Early-Stage Life Sciences Companies
Q&A: Your IT Roadmap – Guidance for Early-Stage Life Sciences Companies The following questions were asked during the IT Roadmap webinar presented by
An Open Letter to Medical Device Regulators
We only have to look at what the ubiquitous use of National Drug Code (NDC) numbers in the U.S. has achieved for prescription drugs. Learn more here!
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.
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.
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