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Frameworks and long-form guidance for governed AI, validation, cybersecurity, and life sciences transformation.
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Showing 33 of 33 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, govern AI-enabled partners, 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 can accelerate clinical, regulatory, quality, and operational transformation in biotech and pharma while preserving governance, validation, and human oversight.
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.
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
Learn how to run inspection-ready virtual audits with secure evidence exchange, remote walkthroughs, vendor qualification controls, and defensible GxP documentation.
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 to strengthen eSignature security, identity assurance, audit trails, encryption, AI-enabled workflows, and data integrity controls in regulated life sciences.
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
Clarify validation responsibilities for SaaS and cloud systems, leverage vendor evidence, apply CSA principles, and close GxP validation gaps with risk-based controls.
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!
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.
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 Google Cloud and USDM help life sciences teams build compliant cloud programs with GxP controls, DevOps evidence, data governance, and cloud assurance.
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
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.
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.
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
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.
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!
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
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.
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
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!
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.