Resources
White papers
Frameworks and long-form guidance for governed AI, validation, cybersecurity, and life sciences transformation.
All resources
Showing 31 of 31 resources
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.
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
Transformative Outcomes in Life Sciences
In this white paper, discover the power of PTC ThingWorx for connected, GxP compliant, and intelligent regulated-environment operations.
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.
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!
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.
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.
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.
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.
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!
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!
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.
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.
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!
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!
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.
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.
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.
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!
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.
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.
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!
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.
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.
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.