Resources
Resources for regulated transformation.
Guides, webinars, articles, and proof points organized around the decisions life sciences teams actually need to make: AI governance, validation, data integrity, platform operations, and risk.
Resource categories
A cleaner library for buyers, operators, and technical teams.
The library is now organized by resource type and decision path instead of exposing the old migration structure.
White papers & guides
Executive-ready frameworks, checklists, and downloadable guidance for regulated AI, validation, and risk programs.
Webinars & on-demand
Recorded briefings and event content for teams that need expert context before they commit to a program.
Articles & insights
Timely perspectives on AI governance, GxP compliance, cybersecurity, data integrity, and digital transformation.
Case studies & proof
Outcome-oriented stories, partner examples, and practical proof points from regulated transformation work.
Featured path
Start with governed AI, then move into execution.
For most regulated teams, the right first sequence is framework, readiness assessment, use-case prioritization, then validation and operating model.
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Validation, CSV & CSA
Veeva & platform operations
Cybersecurity & third-party risk
Data integrity & analytics
White papers & guides
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.
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.
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.
Life Sciences Cybersecurity: Building a Trusted Partner Ecosystem
Learn how life sciences cybersecurity programs can strengthen vendor oversight, reduce third-party risk, and build an inspection-ready partner ecosystem with continuous assurance.
Webinars & on-demand
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
Discover what the EUDAMED launch means for MDR/IVDR compliance—and how to stay audit-ready with USDM’s expert guidance. Register now.
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.
All resources
Showing 280 of 280 resources
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 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.
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 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.
MCP, Connectors, and Skills: The New Integration Layer for Regulated AI
A life sciences view of Claude connectors, Skills, and the Model Context Protocol as an integration layer that must be governed for access, evidence, validation, and change control.
Agents in GxP Workflows: How to Govern Claude Without Freezing Innovation
How life sciences companies can govern Claude-supported agents in GxP workflows with scoped autonomy, human oversight, validation, monitoring, and change control.
Layer 0-5: A Life Sciences Operating Model for Claude Adoption
USDM’s Layer 0-5 operating model for Claude adoption in life sciences: intended use, governed context, connectors, skills, agents, and evidence-based governance.
Work AI for Life Sciences: Why USDM Chose Glean
USDM explains why Glean's Work AI platform is a strong fit for life sciences and how the partnership helps regulated companies turn enterprise knowledge into action.
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. Audit-Readiness in life sciences depends on continuous compliance, traceability, and defensible processes that keep teams prepared for inspec
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. Learn how to improve EU MDR/IVDR EUDAMED readiness with practical steps for data, registration, governance, and global medical device regulatory
AI Readiness Assessment for Life Sciences
Learn how an AI Readiness Assessment helps life sciences organizations establish governance, validate AI systems, and scale adoption under GxP requirements and evolving FDA, EU AI Act, and ISO 42001 expectations. Learn how an AI Readiness Assessment helps life sciences organizations establish govern
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
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.
Agents Without Owners: What RSA 2026 Revealed About the Agentic AI Governance Gap
Explore agentic AI governance challenges as deployment outpaces existing security frameworks across organizations.
Is Your Veeva Vault Delivering the Value You Paid For?
Discover why Veeva Vault value plateaus after go-live — and how a lifecycle operating model reduces compliance risk, cuts costs, and prepares your platform for AI. Discover why Veeva Vault value plateaus after go-live — and how a lifecycle operating model reduces compliance risk, cuts costs, and pre
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.
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.
UDI and FDA’s New QMSR Inspection Process
FDA’s QMSR and updated inspection program (CP 7382.850) put UDI compliance at the center of medical device inspections. Learn how UDI ties to ISO 13485 alignment, GUDID accuracy, and inspection readiness—and how to prepare.
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
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 millions. Learn how intelligent workflow automation and smarter architecture eliminate duplication, reduce compliance risk, and deliver measurable financial returns in 2026.
AI-Enabled QMS: How Deviation and CAPA Workflows Are Changing in 2026
AI is transforming QMS in 2026—from deviation triage to CAPA documentation. Learn what’s working now and how to embed AI into validated workflows.
Organizational Change Management for Life Sciences Companies
Organizational change management in life sciences must evolve for AI. Learn why traditional OCM fails and how compliance-integrated AI adoption succeeds.
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
The New Digital Trust Crisis in Life Sciences: 5 Risks You Can’t Ignore in 2026
Digital trust is the 2026 survival issue for life sciences. Explore five critical risks across AI, cloud, vendors, and governance—and how to address them. Digital trust is the 2026 survival issue for life sciences. Explore five critical risks across AI, cloud, vendors, and governance—and how to addr
Why AI Adoption Is Failing in Life Sciences
AI adoption is failing in life sciences. Learn why most pilots stall and what leaders must do now to drive compliant, measurable AI impact.
Life Sciences Cybersecurity: Building a Trusted Partner Ecosystem
Learn how life sciences cybersecurity programs can strengthen vendor oversight, reduce third-party risk, 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
Explore what AI compliance means in 2026 for life sciences. Learn key FDA, EU AI Act insights, validation tips, and how to scale AI responsibly.
Modernizing TPRM for an AI-Driven Ecosystem: What Good Looks Like in 2026
Life sciences must modernize TPRM to safely scale AI and cloud tech. Discover 2026-ready risk strategies that enable innovation, compliance, and trust.
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
Discover what the EUDAMED launch means for MDR/IVDR compliance—and how to stay audit-ready with USDM’s expert guidance. Register now.
FDA AI Guidance 2025: What Life Sciences Must Do Now
Explore the FDA’s evolving AI enforcement, new guidance, and what life-science organizations must do to stay compliant with AI in GxP environments.
How to Leverage USDM's Vendor Audit of Oracle Supply Chain Management Cloud
How to Leverage USDM’s Vendor Audit of Oracle Supply Chain Management Cloud
The Hidden Costs of Offshore IT Projects in Life Sciences: Why Local Expertise Matters
Discover why offshore IT projects fail in life sciences and how USDM Life Sciences delivers local, compliant, and accountable project success.
ETM.AI: The AI-Enabled Digital Enterprise Trace Matrix
USDM and Oracle are transforming Enterprise Trace Matrix management with AI-driven compliance built into workflows for continuous audit readiness.
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.
The Model Context Protocol (MCP) in Life Sciences
Learn how MCP empowers AI in life sciences while meeting HIPAA, GxP, and 21 CFR Part 11 compliance and security requirements.
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
Get expert answers to top EUDAMED compliance questions and learn how to avoid costly registration pitfalls before the 2026 deadline.
Evaluating Google Agentspace for Life Sciences
Discover 10 key factors life sciences must assess when adopting Google Agentspace for secure, compliant AI integration.
Oracle Fusion to Redwood Migration Guide: Timeline, Strategy, and Best Practices
Migrate from Oracle Fusion to Redwood with confidence using USDM’s step-by-step strategy, timelines, and compliance-first best practices.
Security Over Speed: Applying J.P. Morgan’s Cyber 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.
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 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 are transforming biotech and pharma—accelerating clinical trials, streamlining compliance, and reducing costs
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 cyber 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
Discover how life sciences organizations use data strategies, APM, and AI to boost efficiency, ensure compliance, and drive innovation. Watch on-demand now!
Transforming Enterprise Asset Management
Discover how advanced technologies like AI and IoT transform asset management in life sciences. Learn about USDM and Blue Mountain's innovative solutions.
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
In this white paper, discover the power of PTC ThingWorx for connected, GxP compliant, and intelligent regulated-environment operations.
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.
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.
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.
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
Learn why data integrity in life sciences matters for compliance, quality, and AI readiness, and explore best practices for governance, automation, and secure digital records. Learn why data integrity in life sciences matters for compliance, quality, and AI readiness, and explore best practices for
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
Ensure compliance and boost data quality with robust governance. Learn how data classification, lineage, security, and stewardship drive innovation.
GxP Training in Today’s Regulatory and Technology Landscape
Modern GxP training with VR, AI, and blockchain boosts compliance, minimizes risks, and improves ROI, ensuring quality, safety, and efficiency in life sciences.
LLMs and Cybersecurity Standards in Life Sciences
LLMs present opportunities to advance drug discovery and development, but protecting the data being processed takes precedence.
Modernize Your Audits and Compliance with Tech Innovations
Discover how GenAI, AR/VR, and IoT are transforming life sciences audits by improving compliance accuracy, reducing costs, and enabling proactive risk management.
Good Automated Manufacturing Practice vs. Computer Software Assurance
CSA modernizes and refines GAMP 5 practices to make validation more efficient without compromising system quality or compliance.
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.
Penetration Testing in Life Sciences Lab Environments
Learn what penetration testing is and why it’s a critical component of a comprehensive cybersecurity strategy.
Q&A: Ensuring AI Compliance and Maximizing the Value of Your GxP Technologies
USDM answers questions about starting and scaling AI initiatives in the life sciences industry and protecting sensitive data.
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.
Cybersecurity in Medical Devices: How Did 524B Come About?
Section 524B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) recognizes the need for robust cybersecurity measures in medical devices.
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.
Manual Testing vs. Automated Testing
Explore the key differences between manual and automated testing and discover the benefits of automated regression testing.
The Importance of CIS Critical Security Controls (CIS18) in Life Sciences
Security breaches in life sciences underscore the need for robust cybersecurity measures. Learn how to implement CIS Critical Security Controls to strengthen your cybersecurity posture and mitigate risk.
Workforce Optimization: Maximizing Employee Efficiency and Productivity
Workforce optimization ensures that the right people are performing the right tasks. Find a delivery model that best fits your organization.
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.
Q&A: Mandatory Use of EUDAMED Now Starting Q1 2026
Jay Crowley and Lionel Tussau help make medical device manufacturers aware of key dates, requirements, and regulatory implications.
Computer System Validation Services: Rethinking CSV vs CSA for Life Sciences Innovation
Explore computer system validation services, understand CSV vs CSA, and learn how life sciences companies can modernize validation to improve compliance, speed, and scalability.
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!
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!
Deepfakes and Financial Fraud
Learn why the prevalence and sophistication of deepfake technology in fraud attempts have increased significantly in recent years.
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 attended the Google Cloud GenAI in Life Sciences Summit in New York and had some insightful conversations with industry peers.
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
Discover a solution where the costs and benefits of AI projects are accrued to the business units justly and transparently. Learn more today!
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
Learn about the resources required and outcomes you can expect in these two stages of AI technology development and deployment.
Best Practices for Virtual Audits and Regulatory Inspections
Explore how USDM leverages remote audits with virtual tools like AR, VR, and cloud systems to streamline vendor qualification and regulatory compliance.
USDM's Guide to 21 CFR Part 11
Learn about 21 CFR Part 11, the FDA regulation ensuring the security, traceability, and compliance of electronic records and eSignatures in life sciences.
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
Explore how AI transforms recruitment into a technologically advanced process that improves candidate sourcing and boosts efficiency and effectiveness.
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.
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
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!
Minimize Operational Debt by Modernizing and Automating
Embrace modern technology to experience extraordinary results and gain a competitive advantage. Learn more in our latest blog!
A Few Surprises in FDA's Quality Management System Regulation
For most manufacturers, the new QMSR will simplify their approach to quality system compliance. Learn more today!
Lessons Learned in the On-Going RPA Journey
The multitude of tests within the framework has enabled USDM teams to gain valuable insight and improve the RPA process as it evolves.
6 Considerations for Reducing Your IT Cost of Ownership
Learn what factors to consider when choosing technology and systems for your life sciences organization. Learn more today!
Anticipating Regulatory Compliance for Artificial Intelligence in Life Sciences
This whitepaper addresses the lack of regulatory guidelines for AI & introduces an interim path forward to realize the value of AI for life sciences organizations.
RPA GxP-relevant Use Cases
We mentioned several GxP use cases in Part 1 of this blog series, so let’s get into some details about what is possible with RPA.
Enhancing Security and Ensuring Data Integrity in eSignature Solutions
Learn how artificial intelligence (AI) helps to improve efficiency and simplify compliance in the electronic signature (eSignature) process.
Using AI to Help Ensure Compliance while using eSignatures
Learn how artificial intelligence (AI) and machine learning contribute to secure and compliant signing processes in the life sciences industry.
Use AI to Personalize the eSignature Experience in Life Sciences
AI delivers a user experience based on preferences, behaviors, and historical interactions. Explore opportunities for personalization in the eSignature process.
How AI is Transforming eSignature Workflows in Life Sciences
Learn how AI helps to automate and optimize eSignature workflows from beginning to end and empowers you to be more efficient and productive.
Maximize eSignature Security with AI in Life Sciences
Explore various ways that artificial intelligence helps to ensure that a signatory is who they claim to be.
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
Guidance for data management and system implementation for complaints handling. Learn more from USDM Life Sciences experts today!
Outsource Your Complaint and Adverse Event Management
Blog article topic: Learn the best practices to help get your complaint and adverse event program in place.
Overcome Workforce Challenges with Augmented Reality
Address skills gaps, enhance the training experience, and improve job satisfaction with forward-thinking solutions. Learn more today!
Anticipating the Use of Generative AI in Life Sciences
Global regulatory agencies are not ready for artificial intelligence (AI) that doesn’t have a human in the loop. Learn more now!
Be Confident and Ready for Your Next Regulatory Inspection
Blog article topic: Learn how to get your employees inspection ready with a mock audit.
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
Learning to apply generative AI to life sciences use cases has the potential to advance scientific understanding & improve patient outcomes.
Why Integrated GxP Compliance is More Progressive than Traditional Managed Services
Learn why defining and measuring value helps to provide a trusted solution that responds to changes and scales to meet your needs.
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
Outcome-based next-generation business models empower Quality teams to be proactive in minimizing risk and ensuring regulatory compliance.
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
In the fast-paced landscape of emerging life sciences firms, one critical aspect often overlooked is the need for robust cybersecurity measures.
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
Establishing and implementing cybersecurity controls is essential for every life sciences organization. Read now to learn more!
Validation Requirements and Responsibilities
Who’s responsible for what in the validation process? Get the white paper for more information to make your validation more efficient.
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.
Good Manufacturing Practices (GMP): Ensuring Quality in Manufacturing Processes
Quality in manufacturing is imperative. See how USDM Life Sciences can help organizations maintain Good Manufacturing Practices!
Good Clinical Practices (GCP): Ensuring Ethical and Reliable Clinical Research
Learn about Good Clinical Practices (GCP) and our services to help assist with ensuring them. Read this blog today!
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
Feeling confused by UDI implementations? See USDM Life Sciences tips in this blog. Learn more today!
Lessons from the USDM Cloud Assurance Box GxP Automated Testing Tool
Blog article topic: Lessons from the USDM Cloud Assurance Box GxP Automated Testing Tool.
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.
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
The data your organization generates and stores can still be overwhelming to transform it into meaningful and actionable insight.
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
Learn how to select the right software vendor to help you achieve your business objectives and set you up for success.
Manual Processes Result in More Errors
Learn how modern technology and automation help you achieve better quality and compliance. Read more today!
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
Blog article topic: Q&A from UDI Beyond Borders Webinar.
Applications of Blockchain Technology Within Pharmaceutical Supply Chain and Quality Management Systems
Blockchain technology will improve the overall security and efficiencies within the pharmaceutical supply chain management process.
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
Blog article topic: Learn how to apply Agile development methods to build high-quality systems that meet the relevant regulatory and industry standards.
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.
What is Compliance as a Code?
Learn about Compliance as a Code (CaC) from our subject matter experts in our newest blog post. See how USDM helps!
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
Blog article topic: Learn the hidden cost of paper-based processes and wet signatures
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
Tips for maintaining quality during transitions and critical vs non-critical gxp applications. Learn more today!
Five Tips for GxP Vendor Qualification
A practical guide to make a new technology purchase decision in the life science industry. Learn what to be on the look out for!
Interim CIO Advisory Services for Emerging Life Science Companies
Increase operational success and strategic alignment with the help of a fractional CIO.
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
Having applications on the cloud provides a standard for common interfaces among cloud applications, & an improvement in network performance.
Data Migration
Migrating your data to the cloud provides scalability, cost effective data backup & archiving, & stronger security than traditional data centers
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.
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.
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.
Process Automation for Regulated GxP Workflows
USDM customized workflows, demonstrated a framework for continuous compliance & responded to questions about regulatory requirements for the featured customers.
GxP Expertise for Program and Project Management
USDM’s project and program management experts help lead and support your mission-critical projects and highly regulated cloud technology implementations.
Adapting Computer System Validation to Accommodate Evolving FDA Guidance
Blog article topic: Adapting Computer System Validation to Accommodate Evolving FDA Guidance. Learn more today!
List of Supported Regulations
We pride ourselves on staying current with the global regulatory landscape and are consistently at the forefront of driving change to keep up with technology.
How to Align your CSV Program with the FDA’s CSA Approach
The life sciences industry’s quest for improved patient safety & product quality is heavily dependent on the use of technology throughout its business processes.
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.
Most Misunderstood and Misapplied UDI Requirements
Blog article topic: Most Misunderstood and Misapplied UDI Requirements.
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
Blog article written from the Q&A during the EU MDR Date of Application Readiness webinar.
Is There a Checklist for GCP Audits?
The auditors at USDM recommend including a checklist as part of your quality assurance process – don’t wait until you get an audit notice to prepare.
How Do Life Science Companies Qualify Vendors and Software?
Automated equipment & systems used by companies are supplied by vendors & are purchased off-the-shelf (OTS). Learn more in this blog!
Five Tips for Successful Veeva Implementation
Blog article topic: Five Tips for Successful Veeva Implementation. USDM is a premier services partner with years of experience.
FDA CBD Enforcement Report Released to Congress
Blog article topic: FDA CBD Enforcement Report Released to Congress. Learn about the newest CBD guidance from the FDA.
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!
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.
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.
Virtual Audits and Inspections
Explore how virtual audits streamline vendor qualification and regulatory compliance. Learn about technologies enabling efficient remote assessments.
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.
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.
Cybersecurity Threats and Risks to Life Sciences Companies
On-demand webinar topic: Cybersecurity Threats and Risks to Life Sciences Companies.
An Introduction to Computer Software Assurance
On-demand webinar topic: An Introduction to Computer Software Assurance.
Validating SharePoint for Life Sciences Regulated Environments
Blog article topic: Qualifying SharePoint for Life Sciences Regulated Environments.
Content Orchestration
Content Orchestration is the seamless creation and management of content among teams in your organization.
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!
DevOps Framework
A compliance framework for DevOps is for when you have a business & technical need for automation of developing & deploying code in the GxP environment.
Rapid Application Migration
Rapid application migration, commonly referred to as “lift & shift,” is a typical starting point in a life sciences company’s cloud adoption journey.
Top 10 Recurring Audit Observations at Life Sciences Companies
Blog article topic: Top 10 Recurring Audit Observations at Life Sciences Companies.
Embracing the Fundamental Change Brought on by Digital Transformation
It’s more than just “moving to the cloud.” Digital transformation changes how your organization operates.
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
USDM Life Sciences specializes in helping life sciences companies achieve and maintain continuous compliance with their cloud solutions.
What’s new in Veeva Vault 22R1
The Veeva 22R1 release is coming April 22. We know it can be difficult to keep up with these system changes. Read our blog to learn what it means for you.
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?
Blog article topic: What are Key Performance Indicators for a Life Sciences Project?
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.
Cellular Therapy Regulations
USDM helps you identify your quality management & control needs to ensure that your manufacturing processes are adequately defined, flexible, & validated.
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
Blog article topic: Cloud 101: Part 2 – Vendor Management and Scaling to the Cloud. See USDM Life Sciences solutions in this blog!
Cloud 101: Part 1 – Cloud Service Models
Cloud service models to fit your business needs. An introduction to IaaS, PaaS, and SaaS to help you embrace the benefits of cloud-based systems.
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.
Google Cloud Platform for Life Sciences and Health Technology
Learn how USDM has partnered with Google Cloud Platform for Life Sciences GxP applications. Download the whitepaper today!
Q&A: Simplifying Regulated GxP Business Processes in ServiceNow
Blog article topic: Q&A: Simplifying Regulated GxP Business Processes in ServiceNow.
Robotic Process Automation 101
Robotic Process Automation (RPA) is software that is a bot to emulate how humans interact with digital systems to execute routine or repetitive business tasks.
Remanufacturing of Medical Devices, New DIs, and Software Updates
Blog article topic: Remanufacturing of Medical Devices, New DIs, and Software Updates.
Data Migration Guidance
Blog article topic: Data Migration Guidance. Whatever migration requirements you identify, a data migration plan is essential.
An Introduction to Software Validation
USDM’s approach to software validation starts with defining user specifications & the software’s intended use. See USDMs Software Validation!
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
Learn why outsourcing cloud vendor qualification saves time, reduces risk, and ensures compliance with FDA standards. Download the white paper now.
Reimagining Medical Device Post-Market Surveillance
On-demand webinar topic: Reimagining Medical Device Post-Market Surveillance.
Q&A: SaMD Regulations and Compliant Development Environments
Blog article written from the Q&A during the SaMD Regulations and Compliant Development Environments webinar.
The Origins of UDI
In this are article, we tell the story of the Unique Device Identification (UDI) System regulation.
GCP Investigators: Do Regulations Require a CV to Be Updated Every Two Years?
Blog article topic: GCP Investigators: Do Regulations Require a CV to Be Updated Every Two Years?
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.
Project Management: Rules of Engagement
Establishing rules for accountability and responsibility are critical to a project management team’s success.
5 Tips to Drive Your IT and Compliance Strategy for IT Leaders in Emerging Life Sciences
Blog article topic: 5 Tips to Drive Your IT and Compliance Strategy for IT Leaders in Emerging Life Sciences.
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 the FDA's CSA framework modernizes software assurance in life sciences. Focus on risk-based testing, quality improvement, and patient safety.
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.
Top Cloud Insights for Life Sciences
Your starting point in finding answers to your cloud questions, including regulatory compliance, audit and assessment, and validation.
Top CSA Insights
See our top insights on Computer System Validation (CSV) guidance & learn what the risk-based approach of Computer Software Assurance (CSA).
Key differences in the requirements for SFDA UDI and US & EU UDI
Blog article topic: Key differences in the requirements for SFDA UDI and US & EU UDI.
Q&A: UDI Registration in EUDAMED
Blog article written from the Q&A during the UDI Registration in EUDAMED webinar.
Are You Ready for the Veeva 21R3 Release?
The Veeva 21R3 pre-release is here. We know that it can be quite challenging to keep up with these system changes. Get the tips here!
Information System (IS) Compliance Health Check
Blog article topic: Information System (IS) Compliance Health Check. What is your level of cloud readiness and 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
Download our white paper & learn how you can securely share data with partners, vendors, & regulators while complying with GxP requirements.
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?
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.
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.
Is it Acceptable to Push Back if You Disagree with a Notice of Violation or 483?
Blog article topic: Is it Acceptable to Push Back if You Disagree with a Notice of Violation or 483?
Benefits of Pharmaceutical Serialization
Serialization can prove a products authenticity, which means a manufacturer can detect & combat counterfeit products and ultimately protect their company brand.
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.
Another Regional UDI Database: Singapore's UDI Implementation
Blog article topic: Another Regional UDI Database: Singapore’s UDI Implementation.
Top 5 Ways to Be Successful with Salesforce and GxP
Blog article topic: Top 5 Ways to Be Successful with Salesforce and GxP.
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!
Becoming a Cloud-First Company
USDM can help your company create a strategy that will ensure quality & compliance through your digital transformation & sustain you as a cloud-first company.
The Evolving Global UDI Landscape
We also realized very early on that the ultimate objective was not a US based UDI system but rather a GLOBAL system. Learn about the global UDI system effects!
Top 10 Reasons Life Sciences Organizations Should Move to the Cloud
Blog article topic: Top 10 Reasons Life Sciences Organizations Should Move to the Cloud.
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.
USDM and DocuSign – Compliant Now, Compliant Forever
Blog article topic: USDM and DocuSign – Compliant Now, Compliant Forever.
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
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!
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
USDM shares valuable lessons to help you examine your future IT system needs and embrace the opportunities afforded by moving deeper into the cloud.
The Direct Marking of Medical Devices in the U.S. and Europe
White paper on The Direct Marking of Medical Devices in the U.S. and Europe. Learn more about medical device marking today!
Caution about FDA’s Most Recent UDI "Enforcement Discretion" Guidance
Blog article topic: Caution about FDA’s Most Recent UDI “Enforcement Discretion” Guidance. Learn more today!
On-site and Remote Audit Best Practices
There are ways to prepare for on-site and remote audits that make them as efficient & hassle-free as possible. Here are some best practices from the USDM.
Compliance & Technology Trends for 2021
On-demand webinar topic: Compliance & Technology Trends for 2021. See the trends shaping the life sciences industry!
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
What are the medical device regulatory effects of Brexit? Click here to read more on the implications of Brexit for medical device manufacturers.
2021 Life Sciences Trends
Learn about the 2021 trends in the life science industry put together by our experts at USDM Life Sciences. We put together the highlights for you!
Preemptive Growth Strategy for Cannabis and CBD Companies
White paper on Preemptive Growth Strategy for Cannabis and CBD Companies. Learn more in this white paper focused on cannabis regulations.
Using PTC's ThingWorx Solution in a GxP Regulated Environment
White paper on Using PTC’s ThingWorx Solution in a GxP Regulated Environment.
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!
Selecting, Implementing, and Maintaining Cloud Systems for the Life Sciences Industry
White paper on Selecting, Implementing, and Maintaining Cloud Systems for the Life Sciences Industry.
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.
Regulatory Risk Reduction in the Cloud: Why Cloud Systems Are Safer Than On-Premise Systems
White paper on Regulatory Risk Reduction in the Cloud: Why Cloud Systems Are Safer Than On-Premise Systems.
Life Sciences Trends for 2020
Trust in the technology, data, & partnerships necessary to succeed requires a new level of digital trust that can create feelings of uncertainty in companies.
Challenges with UDI During COVID-19 Pandemic
Blog article topic: Challenges with UDI During COVID-19 Pandemic. During the COVID-19 how is your company handling UDI compliance?
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