At USDM Life Sciences, our purpose is to bring clarity and action at the interplay of technology and regulations to help biotech, pharma, and medical device companies deliver trailblazing outcomes. We help our customers utilize cutting-edge technology to increase their speed to market while ensuring continuous compliance and patient safety.Jim has helped develop many of the regulatory compliance and IT programs at USDM including; our Unique Device Identification (UDI) program, EU MDR / IVDR programs, QMS strategies, complaint and adverse event support, RIMS initiatives and our Drug Supply Chain Security Act (DSCSA) compliance services for the medical device and … Bob was born and raised in Philadelphia and still lives in the area. Bob lives with his wife of 42 years and has three grown children and two grandchildren. He loves music and sports and currently plays in a rock cover band in the Philly area. Lead Auditor for global audits that include quality, regulatory, IT, and validation components for ... 5 free lookups per month. Kevin Brown's Work. Managing Partner @ USDM Life Sciences; Consultant @ Computerfocus. Kevin Brown's Education.Nov 9, 2022 · EU MDR and IVDR Compliance. Medical device manufacturers must comply with EU MDR by May 26, 2021, and IVDR by May 26, 2022. USDM Life Sciences offers many solutions to help plan, execute, and manage any or all enterprise-wide activities necessary to meet the European Union (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation ... USDM Life Sciences website. USDM Life Sciences provides a variety of IT and compliance solutions to help life sciences companies streamline laboratory, clinical and …USDM Life Sciences, Santa Barbara. 407 likes · 36 were here. Bringing clarity and action to the interplay of technology and regulations to help biotech, pharma, aIn partnership with USDM Life Sciences, SAP S/4HANA allows regulated medical devices and life sciences companies to continuously meet all their compliance needs covering the solution and regulation simultaneously with our Cloud Assurance Subscription program. Any upgrade in the cloud is comprehensively assessed and supported to ensure the system …USDM is a leading global professional services firm focused exclusively on providing… · Experience: USDM Life Sciences · Education: California State University, Northridge · Location: Santa ...Hussam is passionate about bringing measurable business value to our customers through consistent, effective, high-quality delivery of USDM services that increase productivity and decrease costs. Before USDM, Hussam spent the majority of his career at Amgen leading enterprise-wide IT programs focused on quality and compliance to mitigate risk and … Holger Brämer is the EVP of European Operations at USDM Life Sciences. In this capacity, Holger is responsible for planning and executing business operations in Europe, overseeing revenue, growth, and profitability. He is located in Germany and serves as the main point of contact for all European customers and partners of USDM. USDM Life Sciences has thorough processes, SOPs, and checklists to ensure that you follow the guidelines. We can also help you build a data integrity program that fits with your company’s priorities, plus: Assess and detect areas of risk. Remediate risks. Build a governance structure. Define a compliance strategy. Provide training programs.Nov 9, 2022 · EU MDR and IVDR Compliance. Medical device manufacturers must comply with EU MDR by May 26, 2021, and IVDR by May 26, 2022. USDM Life Sciences offers many solutions to help plan, execute, and manage any or all enterprise-wide activities necessary to meet the European Union (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation ... Aug 8, 2023 · Who is USDM Life Sciences. USDM Life Sciences is a global life science and healthcare consulting services company, providing strategy and compliant technology solutions to re gulated industries. USDM Life Sciences has offices in Santa Barbara, California, and Frankfurt, Germany. Read more. USDM Life Sciences's Social Media Life Sciences Trends for 2020. Various Authors. November 13, 2019. The life sciences industry is changing at unprecedented rates. In 1999, life sciences companies spent 1-2% of revenue on information technology relative to other high-tech industries because FDA regulations were too restrictive. We are seeing growth in …When it comes to gaming, there are few experiences as intense and captivating as the 60 seconds game. This fast-paced adventure game puts players in a race against time, challengin...11 Aug 2015 ... How to Avoid Common Pitfalls with Computer System Validation Projects. 1.7K views · 8 years ago ...more. USDM Life Sciences.Employee Involvement Plan. The USDM OCM team analyzes your work streams to determine what activities can be used to build awareness and buy-in, then we identify change leaders who will help tailor messages to your broader internal audiences. Our OCM team will meet with a designated transformation leader bi-weekly to share …Feb 14, 2024 · Life Science Industry technology experts and innovators will be at Next ‘24 sessions to dive deep into: Accelerating molecule to market with leveraging validated and qualified generative AI modeling. Implementing a life sciences cloud native clinical data repository and data lake for regulatory submissions and gene therapy analytics. USDM ... USDM Life Sciences provides strategy and compliant technology solutions to regulated life sciences companies and makes it easy to accelerate transformation and innovation. USDM Life Sciences focuses exclusively on the regulated biotechnology, pharmaceutical, and medical device industries and is a compliance partner with the …As life sciences companies progress in their automation maturity—from rule-based automation to virtual agents, cognitive agents, and AI/machine learning—USDM offers solutions to optimize use cases and applies computer software assurance (CSA) to drive efficiency. Watch the Automated GxP Cloud Compliance session from the USDM …After decades of getting to know robotic animals through books and film, innovators have finally brought them into reality. Robots are everywhere these days. They can clean our hom...USDM Life Sciences is a consulting company that focuses on the life sciences sector. The company offers services such as automation of routine GxP workflows, cybersecurity, data integrity, and compliance management, all aimed at improving the interplay of technology and regulations. It primarily serves the biotech, …USDM is pioneering the integration of advanced AI models in life sciences organizations to help them generate dynamic content with text, images, and more. Our generative AI services are finding applications in content creation, design enhancements, and decision support systems. Data Management. Elevate your data experiences with technology and ...Diane has over three decades of experience in the life sciences industry and leads a highly skilled team of implementation and compliance engineers. Her in-depth knowledge of the regulatory landscape and unwavering passion has been instrumental in rooting USDM’s focus on regulatory compliance for life sciences customers. Over her tenure ...Watch USDM’s virtual event specifically for pre-commercial life science companies: Emerging Life Sciences on-demand webinar. Defining Good Laboratory Practice GLP is a set of internationally recognized quality assurance principles and guidelines that govern the conduct of non-clinical laboratory studies.Life sciences companies are aiming to boost innovation, quality, and speed with digitalization, new and evolving technologies, and third-party providers. However, these solutions may also introduce cybersecurity vulnerabilities. Security breaches target intellectual property and clinical trial data at life sciences companies and their third ...Nearly every day in our lives, science moves our knowledge and understanding forward bit by bit and brings new wonders to light. Men and women around the world have been driven sin...Meet Jayne Gill –Managing Director, Life Sciences Consulting Jayne joined USDM earlier this year and has continued to successfully grow and drive our USDM Consulting Division. She is responsible for the continuous improvement and acceleration of how USDM delivers specialized talent and consulting services.A GxP DevOps framework increases the frequency and quality of deployments to meet customer and business needs while automating compliance and security. It also enables a GxP-compliant software delivery pipeline. Read our case study to learn how USDM helped a Top 10 global pharmaceutical company create a validated DevOps …Birds are beautiful creatures that bring life and melody to our surroundings. However, when they become a nuisance, causing damage to property or posing health risks, it’s importan... With more than 20 years of experience serving life sciences companies and delivering thousands of GxP projects globally, USDM can fast-track your Salesforce implementation, validation, and enhancements. Easily extend Salesforce to regulated functions like clinical, laboratory, R&D, quality, manufacturing, and other GxP areas. USDM Life Sciences thinks about an organization’s cybersecurity in terms of maturity. Improving cybersecurity maturity is a process of continuous improvement. Due to the evolving threat landscape, there is no end-state maturity. Rather, our goal is to achieve levels of cybersecurity maturity that align with risks, threats, company size ...View David Blewitt at USDM Life Sciences on The Org.USDM Life Sciences's annual revenue is $73.0M. Zippia's data science team found the following key financial metrics about USDM Life Sciences after extensive research and analysis. USDM Life Sciences has 350 employees, and the revenue per employee ratio is $208,571. USDM Life Sciences peak revenue was $73.0M in 2023. Contact USDM for your GxP-compliant content management solution. Download the Box GxP datasheet. Life sciences organizations can create, collaborate, manage, and distribute information with their employees and partners—all backed by enterprise-grade security and compliance. Regulated and non-regulated content can be standardized on a single ... Early-stage life sciences companies face many challenges, but a strategic IT roadmap doesn’t have to be one of them. This powerful tool helps you set and communicate your priorities, and you can adapt it as your circumstances evolve. Functional areas need IT solutions to meet their objectives and a strategic plan for needs, costs, and ...Kidney dialysis is a life-saving treatment for individuals with kidney failure. It plays a crucial role in removing waste products and excess fluid from the body when the kidneys a... and more. As part of application lifecycle management (ALM) in ProcessX, validation lifecycle management (VLM) generates all your validation artifacts automatically and compliantly using the Computer Software Assurance (CSA) methodology or Computer System Validation (CSV) methodology. You’ll receive: Validation plan. Requirements management. Watch USDM’s virtual event specifically for pre-commercial life science companies: Emerging Life Sciences on-demand webinar. Defining Good Laboratory Practice GLP is a set of internationally recognized quality assurance principles and guidelines that govern the conduct of non-clinical laboratory studies.USDM Life Sciences can help you think beyond cloud validation to enable platforms for innovation and new business models. We can help you: Empower data-driven decisions with artificial intelligence (AI) Today, product innovation is possible with the convergence of modern cloud technologies, development platforms, and AI.USDM Life Sciences thinks about an organization’s cybersecurity in terms of maturity. Improving cybersecurity maturity is a process of continuous improvement. Due to the evolving threat landscape, there is no end-state maturity. Rather, our goal is to achieve levels of cybersecurity maturity that align with risks, threats, company size ...Employee Involvement Plan. The USDM OCM team analyzes your work streams to determine what activities can be used to build awareness and buy-in, then we identify change leaders who will help tailor messages to your broader internal audiences. Our OCM team will meet with a designated transformation leader bi-weekly to share … USDM Life Sciences has thorough processes, SOPs, and checklists to ensure that you follow the guidelines. We can also help you build a data integrity program that fits with your company’s priorities, plus: Assess and detect areas of risk. Remediate risks. Build a governance structure. Define a compliance strategy. Provide training programs. DocuSign and USDM’s established partnership draws on expertise from deployments at the Top 20 global biopharma and medical device companies, and high-growth life sciences organizations. With USDM Cloud Assurance, you can use DocuSign to manage GxP validation. DocuSign can be used for HIPAA compliant signatures and data storage, 21 …11 Aug 2015 ... How to Avoid Common Pitfalls with Computer System Validation Projects. 1.7K views · 8 years ago ...more. USDM Life Sciences.John has led all aspects of strategy development and delivered value for pharmaceutical, biotech, medical device, and healthcare companies through; application development and maintenance, ERP, Digital/Analytics (RPA/AI/ML), cloud compliance, cybersecurity, and digital trust. His tenure expands companies such as Capgemini, Taratec, The Janus ... GxP Training Program Details. USDM programs can be delivered on-site or as remote programs. Pricing is based on the number of courses, attendees, and sessions, and programs can be customized for your learning needs. We offer hands-on workshops and comprehension tests to measure training effectiveness, and we include staff learning in our programs. USDM Life Sciences website. USDM Life Sciences provides a variety of IT and compliance solutions to help life sciences companies streamline laboratory, clinical and …In today’s fast-paced world, speed and accuracy are crucial skills in many areas of life. Whether you’re a professional gamer, a data entry specialist, or simply someone who wants ...Rain is an essential component of our planet’s water cycle, playing a crucial role in sustaining life on Earth. To monitor and understand precipitation patterns, scientists rely on...20 Feb 2023 ... Kevin Brown is the CEO of USDM Life Sciences. Kevin has more than 20 years of life sciences experience. Prior to USDM Life Sciences, ...USDM hosted a webinar, Update from the FDA on CSV Changes , with Francisco Vicenty, Case for Quality Program Manager, FDA, discussing the upcoming Computer Software Assurance (CSA) guidance and how life sciences companies can and should be applying the principles and methodologies today. Due to the overwhelming amount of questions …USDM helps you digitally transform your business by creating a link between technology and compliance. 2024 Trends in Life Sciences - Learn about five trends fueling the industry | Whitepaper. Download Now. Search. Search. US: (888) 231-0816. ... Life sciences companies are challenged because the very core of their work is about human existence … Data-driven companies leverage cloud-based solutions for GxP and non-GxP data to develop new business models in their bold pursuit of innovation. Hosted by USDM Life Sciences, this virtual event will help you apply Computer Software Assurance (CSA) guidance for a successful GxP cloud transformation, and senior leaders from regulated life ... In today’s fast-paced world, speed and accuracy are crucial skills in many areas of life. Whether you’re a professional gamer, a data entry specialist, or simply someone who wants ...When it comes to gaming, there are few experiences as intense and captivating as the 60 seconds game. This fast-paced adventure game puts players in a race against time, challengin...View David Blewitt at USDM Life Sciences on The Org. Our Talent, Fueled by Passion, Led with Purpose. Our team of subject-matter experts includes former FDA auditors and regulatory officials whose insight and oversight are part of every project. With superior industry knowledge and real-world experience, our multidisciplinary thought leaders possess the skills to address any opportunities or ... View David Blewitt at USDM Life Sciences on The Org.Mar 8, 2024 · USDM Life Sciences is a company that helps life sciences companies use technology to increase speed to market and ensure compliance. Learn about their services, expertise, events, and leadership team. 10 USDM Life Sciences reviews. A free inside look at company reviews and salaries posted anonymously by employees.Mohamed is an accomplished regulatory and IS compliance professional with over 25 years in the life sciences industry. He has experience in computerized and automated systems for R&D, Production, Quality Management, Supply Chain, and Business Intelligence operations within FDA-regulated industries.This includes the process design, …Holger Brämer is the EVP of European Operations at USDM Life Sciences. In this capacity, Holger is responsible for planning and executing business operations in Europe, overseeing revenue, growth, and profitability. ... Holger brings more than 20 years of experience in the life sciences industry to his role. His focus has been on managing sales and business … USDM Life Sciences has thorough processes, SOPs, and checklists to ensure that you follow the guidelines. We can also help you build a data integrity program that fits with your company’s priorities, plus: Assess and detect areas of risk. Remediate risks. Build a governance structure. Define a compliance strategy. Provide training programs. To help life sciences companies overcome supply chain challenges and safely deliver medications to patients, USDM employs seasoned experts and proven methods to: Establish compliant and efficient manufacturing and supply chain processes. Enable the capacity that’s needed to manufacture or procure drug products, substances, and …Data is the lifeblood of AI. USDM helps your life sciences organization establish a data governance framework that ensures the integrity and security of your data as you apply AI to your business use cases. People are the weak link in responsible AI, but USDM provides the training and expertise to strengthen your position.USDM Life Sciences provides a variety of IT and compliance solutions to help life sciences companies streamline laboratory, clinical and manufacturing operations while staying in compliance with FDA regulations. USDM disrupts convention and delivers compliance with proficiency, simplicity, and efficiency to achieve better results for our …Continuous Improvement and Audits: GMP is a dynamic process that encourages continuous improvement. Regular internal and external audits are conducted to identify areas for improvement, detect any non-compliance issues, and implement corrective actions. Good Manufacturing Practices are essential for ensuring the quality, safety, and … Life sciences companies have cut study startup time by more than 50% and reduced database lock time from 40 days to 14 days using USDM’s methods for standardizing clinical studies. We accomplish this by: Selecting a single vendor for all studies Defining core standards that can be used across studies Building and testing core study components SANTA BARBARA, CALIFORNIA – (November 16, 2021) USDM Life Sciences, a premier consulting firm driving digital transformation and innovation in technology and compliance, announces its first tailor-made event, Forward-Thinking GxP Compliance & Process Optimization, happening on Thursday, January 27, 2022. USDM, …Nov 9, 2022 · EU MDR and IVDR Compliance. Medical device manufacturers must comply with EU MDR by May 26, 2021, and IVDR by May 26, 2022. USDM Life Sciences offers many solutions to help plan, execute, and manage any or all enterprise-wide activities necessary to meet the European Union (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation ... USDM has created a GxP landing zone, purpose-built for the life sciences and designed to 21 CFR Part 11, Annex 11, and relevant GxP requirements providing a pre-configured environment – provisioned through code – to host GxP workloads in the cloud. Google Cloud has unmatched data processing power to bring your life-saving therapies and ...Diane has over three decades of experience in the life sciences industry and leads a highly skilled team of implementation and compliance engineers. Her in-depth knowledge of the regulatory landscape and unwavering passion has been instrumental in rooting USDM’s focus on regulatory compliance for life sciences customers. Over her tenure ...USDM Life Sciences is the most trusted company in the pharma, biotech, and medical device industries for compliant technology solutions. Enabled by USDM Cloud Assurance, we continue to build on this trust with our …Life Sciences Trends for 2020. Various Authors. November 13, 2019. The life sciences industry is changing at unprecedented rates. In 1999, life sciences companies spent 1-2% of revenue on information technology relative to other high-tech industries because FDA regulations were too restrictive. We are seeing growth in …USDM Audit of Google Life sciences and health tech companies are ultimately responsible for ensuring that their technology meets patient safety, data privacy, security, and compliance requirements; however, regulatory bodies realize the importance of the connection between the system owner and the cloud service provider. Some go as far as … For example, a leading life sciences supply chain software vendor wanted to scale validation capabilities without hiring full-time employees. They engaged with USDM for on-demand staff augmentation. USDM provided a team of validation engineers, validation analysts, business analysts, and project managers to support the effort. USDM is a leading global professional services firm focused exclusively on providing… · Experience: USDM Life Sciences · Education: California State University, Northridge · Location: Santa ...Kim oversees USDM’s Cloud Assurance Certification program and welcomes the opportunity to meet with new technology partners committed to accelerating life sciences innovation. You can email her at: [email protected]. Kim lives in Colorado with her two children and enjoys spending time with her family and traveling. She holds a B.S. in ...As life sciences companies progress in their automation maturity—from rule-based automation to virtual agents, cognitive agents, and AI/machine learning—USDM offers solutions to optimize use cases and applies computer software assurance (CSA) to drive efficiency. Watch the Automated GxP Cloud Compliance session from the USDM …USDM has domain expertise that enables trailblazing outcomes in the life sciences industry. Cloud Assurance for PTC Software-as-a-Service (SaaS) solutions enables compliance with the U.S. Food and Drug Administration (FDA)’s 21 CFR Part 11 requirements and validation by way of computer system validation (CSV) and computer …27 Jul 2015 ... USDM Life Sciences•204 views · 25:27. Go to channel · 21 CFR Part 11 | Electronic Records & Electronic Signatures | GxP Computer System ...Whether you are just starting your journey to the cloud or looking to optimize your existing IT systems, our leadership team is here to guide you every step of the way. Get to know our …Before USDM, Vega started a couple of companies and spent time on the boards of various non-profits. Vega was born in Denmark but has lived most of her life in California. She currently lives with her husband and two boys in Santa Barbara and enjoys spending time sailing, biking and hiking. She holds a BA in Political Science with International ... USDM is a trusted advisor and partner for life sciences organizations, offering solutions in IT, regulatory compliance, and domains. Learn how USDM helps over 700 customers in biotechnology, pharmaceutical, medical device, and other industries. Meet Jayne Gill –Managing Director, Life Sciences Consulting Jayne joined USDM earlier this year and has continued to successfully grow and drive our USDM Consulting Division. She is responsible for the continuous improvement and acceleration of how USDM delivers specialized talent and consulting services.
Mar 8, 2024 · Access to clean, well-organized, and interoperable data will differentiate life sciences leaders, foster innovation, accelerate research and development, and contribute to the health and well-being of populations worldwide. Emerging concepts like Data Mesh and Data Fabric offer a means to manage data in a decentralized yet connected manner. . Giants supermarket
Learn how USDM’s Managed Compliance Program drove standardization and efficiency for a global contract biopharmaceutical manufacturer in heavy acquisition mode. Anticipating Regulatory Compliance for Artificial Intelligence in Life Sciences | Whitepaper. Download Now. Search. Search. US: (888) 231-0816. [email protected]. …Diane has over three decades of experience in the life sciences industry and leads a highly skilled team of implementation and compliance engineers. Her in-depth knowledge of the regulatory landscape and unwavering passion has been instrumental in rooting USDM’s focus on regulatory compliance for life sciences customers. Over her tenure ...In partnership with USDM Life Sciences, SAP S/4HANA allows regulated medical devices and life sciences companies to continuously meet all their compliance needs covering the solution and regulation simultaneously with our Cloud Assurance Subscription program. Any upgrade in the cloud is comprehensively assessed and supported to ensure the system …UL’s ComplianceWire️ is the industry-leading compliance training Learning Management System (LMS) designed for life sciences organizations. It is compliant with 21 CFR Part 11 and EU Annex 11 validation requirements. Known as the gold standard LMS for the life sciences industry, this time-tested technology is used extensively by the US and ...USDM Life Sciences. Contact Partner. At USDM Life Sciences, our purpose is to bring clarity and action to the interplay of technology and regulations to help biotech, pharma, …Overview. 92. Reviews. 10. Jobs. 162. Salaries. 7. Interviews. 28. Benefits. 71. Photos. 19. Diversity. + Add a Review. USDM Life Sciences reviews. 3.8. 73% would recommend to …USDM's Cloud Assurance managed services for DocuSign provide a comprehensive implementation solution to meet 21 CFR Part 11 requirements. USDM helps life sciences companies rapidly deploy DocuSign to alleviate current business continuity and compliance bottlenecks. Achieve and maintain continuous cloud compliance and manage new …USDM is a trusted advisor and partner for life sciences organizations, offering solutions in IT, regulatory compliance, and domains. Learn how USDM helps over 700 customers in …Test-taking is never fun, but it’s something everyone has to deal with in life. However, it can be even less fun and more stressful when you do not have effective study habits. Do ...USDM Life Sciences is a company that helps biotech, pharma, and medical device companies use technology to improve speed, compliance, and patient safety. It offers cloud assurance, automation, digital …Prior to USDM, Kevin launched his career as a technology consultant. His passion for innovation, knowledge of enterprise technology, and entrepreneurial spirit have led USDM to become a leading digital solutions provider for regulated life sciences companies. Kevin’s leadership and commitment to the life sciences industry, has created a ... Oracle Supply Chain Management (SCM) & GxP Compliance. USDM Life Sciences and Oracle have partnered for more than 15 years to provide world-class solutions that enable life sciences companies to meet FDA 21 CFR Part 11 regulatory requirements. USDM delivers a trustworthy service that expertly manages GxP compliance for Oracle SCM customers. USDM Life Sciences at the Bio-IT Conference & Expo. Meet with USDM Life Sciences at the Box Booth at Bio-It Conference & Expo. 0. Ryan McDonald. - March 8, 2024. News & Events. Biotech. Information Technology. USDM hosted a webinar, Update from the FDA on CSV Changes , with Francisco Vicenty, Case for Quality Program Manager, FDA, discussing the upcoming Computer Software Assurance (CSA) guidance and how life sciences companies can and should be applying the principles and methodologies today. Due to the overwhelming amount of questions we received ... USDM has domain expertise that enables trailblazing outcomes in the life sciences industry. Cloud Assurance for PTC Software-as-a-Service (SaaS) solutions enables compliance with the U.S. Food and Drug Administration (FDA)’s 21 CFR Part 11 requirements and validation by way of computer system validation (CSV) and computer …Compliance as Code (CaC) (Azure BluePrints, AWS Conformance Packs, etc.) CaC provides a general-purpose compliance framework designed to configure security, operational, or cost …USDM Life Sciences can help you think beyond cloud validation to enable platforms for innovation and new business models. We can help you: Empower data-driven decisions with artificial intelligence (AI) Today, product innovation is possible with the convergence of modern cloud technologies, development platforms, and AI.Jim has helped develop many of the regulatory compliance and IT programs at USDM including; our Unique Device Identification (UDI) program, EU MDR / IVDR programs, QMS strategies, complaint and adverse event support, RIMS initiatives and our Drug Supply Chain Security Act (DSCSA) compliance services for the medical device and …USDM Life Sciences can help you think beyond cloud validation to enable platforms for innovation and new business models. We can help you: Empower data-driven decisions with artificial intelligence (AI) Today, product innovation is possible with the convergence of modern cloud technologies, development platforms, and AI.Watch USDM’s virtual event specifically for pre-commercial life science companies: Emerging Life Sciences on-demand webinar. Defining Good Laboratory Practice GLP is a set of internationally recognized quality assurance principles and guidelines that govern the conduct of non-clinical laboratory studies..