How USDM Can Help For more than 20 years, USDM Life Sciences has helped customers effectively manage and execute their compliance and IT projects. This tightly managed approach led by a virtual project management office ensures that a virtual team can meet your project deadlines on time with transparency and compliance.USDM Life Sciences today announced that ProcessX is now certified as part of the ServiceNow Built on Now™ program. Siloed technology systems for regulated and non-regulated workloads are a burden on IT and Quality teams. ProcessX helps minimize fragmented systems and processes to enable pharma, biotech, and medical …USDM Life Sciences is a global consulting firm for regulated business processes in life sciences. Learn about its founders, industry, location, and funding history on Crunchbase.Explore strategies and solutions like automating validation and GxP processes, creating an AI roadmap and governance framework, and generating value using GxP managed services. Learn more in the white paper, Integrated GxP Compliance for the Life Sciences Industry.Nov 16, 2021 · USDM Life Sciences provides strategy and compliant technology solutions to regulated life sciences companies and makes it easy to accelerate transformation and innovation. USDM focuses exclusively ... Rapid application migration, commonly referred to as “lift & shift,” is a typical starting point in a life sciences company’s cloud adoption journey. Lift & Shift simply means re-hosting on-prem applications in the cloud. As long as the application is cloud ready, there is no new development or code because you aren’t changing technical ...Compliance as Code (CaC) (Azure BluePrints, AWS Conformance Packs, etc.) CaC provides a general-purpose compliance framework designed to configure security, operational, or cost …2 May 2014 ... USDM Life Sciences is a leading global regulatory consulting firm providing compliance, validation, qualification, quality, auditing and ...USDM hosted its first virtual event with an all-star line up of life sciences thought leaders. If you missed our Forward-Thinking GxP Compliance & Process Optimization event, you can watch the replays of the four thought-provoking sessions here. Session 3 – FDA Perspectives on Cloud Technologies 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. 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...USDM’s Approach for Customers. USDM’s approach to software validation starts with defining user specifications and the software’s intended use. We can then move on to the risk assessment to determine if the product is appropriate for the customer’s needs. USDM’s validation plan document defines what will be validated and the …Vice President, Consulting. Roger has over 20 years of experience in both consulting and industry roles in the pharma, biotech, engineering, and semiconductor industries. Working with small and large life sciences firms, Roger has built and led professional services teams to deliver solutions for customer needs and challenges. USDM is a leading global professional services firm focused exclusively on providing… · Experience: USDM Life Sciences · Education: California State University, Northridge · Location: Santa ... 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. 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 …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.27 Jul 2015 ... FDA's UDI Non-Sterile Implant Label Extension. 122 views · 8 years ago ...more. USDM Life Sciences. 489. Subscribe.The final US UDI deadline will have passed (24 September 2022). The initial EU MDR/IVDR UDI label and package requirement deadline has also passed (MDR-complaint implantable and class III devices were 26 May 2021). More MDR and IVDR deadlines are fast approaching (e.g., MDR complaint Class IIa/b devices is 26 May 2023). The FDA issued its draft guidance for Computer Software Assurance (CSA) in September 2022. It’s intended for life sciences companies and their manufacturing, operations, and quality system software; it does not apply to product software. Additionally, the FDA has clearly stated that the CSA approach can be used today and USDM has modernized ... 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 …VP of Life Sciences Technology Solutions. Haresh joined USDM in October 2023. He spent 23 years at Amgen, a Fortune 500 biotechnology company, mostly in IT. His leadership responsibilities include global ERP, Quality systems, commercial analytics and corporate IT. In December 2020, Haresh was appointed head of Amgen’s Shared Services ...3 days ago. Over 200 applicants. See who USDM Life Sciences has hired for this role. No longer accepting applications. About USDM. USDM Life Sciences is a premier … USDM is a leading global professional services firm focused exclusively on providing… · Experience: USDM Life Sciences · Education: University of Southern California · Location: Santa Barbara ... 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...USDM Life Sciences (also known as US Data Management) is a technology consulting firm. It offers regulatory compliance, digital transformation, and cloud assurance solutions. The company caters to medical device, biotechnology, biologics, diagnostics, and pharmaceutical industries.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 …Feb 20, 2024 · USDM plays on the edge of technology and science- working with leading life sciences companies from emerging and fast growing biotech to 100 year old established multi billion medical device and partners including Google, Veeva, Microsoft, Oracle and many more- addressing the challenges of using their technology to speed products to market or ... 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. Google, …When it comes to long-lasting food options, canned meats have always been a popular choice. One such product that stands out is the Hormel 5 lb canned ham. This versatile and conve...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 …At USDM, we enable life sciences companies to accelerate innovation and maximize productivity. More than 200 life sciences companies rely on USDM Cloud Assurance TM, our managed service that offloads your cloud vendor management and maintenance of system updates, patches, and changes. Cloud Assurance provides you … The final US UDI deadline will have passed (24 September 2022). The initial EU MDR/IVDR UDI label and package requirement deadline has also passed (MDR-complaint implantable and class III devices were 26 May 2021). More MDR and IVDR deadlines are fast approaching (e.g., MDR complaint Class IIa/b devices is 26 May 2023). 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 …Keeping your lawn healthy and weed-free requires proper maintenance and strategic planning. One essential tool in your arsenal is the use of pre-emergent herbicides. To understand ...USDM’s Vendor Assurance Report, an annual assessment driven by USDM’s proprietary USDM Compliance Matrix (UCM), assesses your compliance activities related to global regulations. USDM’s Cloud Assurance Certified technology vendors meet the quality and compliance demands of the life sciences industry.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 ...Cloud Assurance provides expert compliance services, fast-start accelerators, and defensible validation deliverables based on 20+ years of life sciences ...Science makes daily life more convenient with discoveries such as electricity and its related inventions that manipulate it to produce light and allow people to use electronic devi...11 Aug 2015 ... How to Avoid Common Pitfalls with Computer System Validation Projects. 1.7K views · 8 years ago ...more. USDM Life Sciences.Life sciences organizations of all sizes struggle to manage cloud spending, technology bloat, and compliance burdens. Validation is complicated and time consuming, but it doesn’t have to be. ProcessX takes the ServiceNow platform , makes it 21 CFR Part 11 compliant, and simplifies compliance by achieving and maintaining IT and Quality regulatory …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 …USDM Life Sciences is a premier consulting company with deep experience assisting life sciences companies with their GxP technologies and business processes. …Sandy Hedberg, Cloud Assurance QA/RA manager, USDM Life Sciences Sandy Hedberg has over 20 years of experience in Quality and Regulatory Affairs in the medical device, pharmaceutical, and biologics industries. She has participated in assisting companies with responses to consent decrees and audit findings to the FDA. She is well versed in risk … The FDA issued its draft guidance for Computer Software Assurance (CSA) in September 2022. It’s intended for life sciences companies and their manufacturing, operations, and quality system software; it does not apply to product software. Additionally, the FDA has clearly stated that the CSA approach can be used today and USDM has modernized ... USDM Life Sciences offers customized solutions for regulated biotech, pharma, and medical device customers. Learn how to optimize and automate y…Science makes daily life more convenient with discoveries such as electricity and its related inventions that manipulate it to produce light and allow people to use electronic devi...How USDM Can Help For more than 20 years, USDM Life Sciences has helped customers effectively manage and execute their compliance and IT projects. This tightly managed approach led by a virtual project management office ensures that a virtual team can meet your project deadlines on time with transparency and compliance.USDM Life Sciences project and program management experts are the perfect fit to help guide, lead, and support your life sciences organization’s mission-critical project and programs initiatives. We specialize in highly regulated areas where compliance, technology, and business intersect and attain your desired business results.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 ...Hovsep also leads USDM’s Veeva services practice. He has nearly 20 years of experience managing projects and programs in the life sciences industry, with a specific focus on the implementation and optimization of enterprise SaaS systems, strategic consulting for C-Suite and Executive leadership, and Business & Digital Transformation in the Life …USDM Life Sciences offers future-state solutions and strategic guidance for new ways of working. Our expertise in Good Manufacturing Practices (GMP) and Good Automated Manufacturing Practices (GAMP) will enable your organization to achieve safety, quality, and reliability in your manufacturing processes. Pharmaceutical Manufacturing.USDM’s Approach for Customers. USDM’s approach to software validation starts with defining user specifications and the software’s intended use. We can then move on to the risk assessment to determine if the product is appropriate for the customer’s needs. USDM’s validation plan document defines what will be validated and the …Mar 8, 2024 · 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 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. Hovsep also leads USDM’s Veeva services practice. He has nearly 20 years of experience managing projects and programs in the life sciences industry, with a specific focus on the implementation and optimization of enterprise SaaS systems, strategic consulting for C-Suite and Executive leadership, and Business & Digital Transformation in the ... 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 …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.USDM can manage your computer system, equipment, or process validation. We ensure that your systems are compliant from implementation to ongoing vendor updates. Quality Management Processes. USDM helps regulated life sciences companies make the best choices when selecting and integrating technology for GxP processes and applications.27 Jul 2015 ... USDM Life Sciences•204 views · 25:27. Go to channel · 21 CFR Part 11 | Electronic Records & Electronic Signatures | GxP Computer System ...USDM plays on the edge of technology and science- working with leading life sciences companies from emerging and fast growing biotech to 100 year old established multi billion medical device and partners including Google, Veeva, Microsoft, Oracle and many more- addressing the challenges of using their technology to speed …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 ...27 Jul 2015 ... Open App. FDA's Drug Supply Chain Security Act - What You Need to Know Before Jan. 1, 2015. 971 views · 8 years ago ...more. USDM Life Sciences.USDM Life Sciences has built its brand on core qualifications and validation services for pharma, biotech and medical device companies. But we don't stop there. We provide end-to-end services so that GxP and non-GxP customers build and implement the compliant systems they need to successfully compete in the industry.USDM Life Sciences is a consulting company that focuses on the life sciences sector. The company offers services such as automation of routine GxP … 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. Written by Chris Merriam-Leith, Director of Emerging Regulatory and Quality at USDM Life Sciences, Quality Management Systems for Emerging Life Sciences Organizations explains the benefits of aligning QMS practices with the top-down subsystem inspection approach taken by regulators. The U.S. Food and Drug Administration (FDA) …Joseph Cassella is the Director of Regulatory Compliance at USDM Life Sciences. With over 25 years of experience in the pharmaceutical, biotech, and medical device industries, Joe’s background is both broad and deep in Information Technology, Laboratory and Analytical Applications, and Quality Systems.Join USDM in Fort Lauderdale, FL | August 24-25, 2023. Join USDM at the Life Sciences Dreamin’ Conference to learn industry best practices and innovative strategies for GxP use cases with Salesforce. Life Sciences Dreamin’ was created to fill an unmet need for Life Sciences professionals: a space to learn Salesforce best practices … 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. 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. Google, …Keeping your lawn healthy and weed-free requires proper maintenance and strategic planning. One essential tool in your arsenal is the use of pre-emergent herbicides. To understand ...The life sciences industry’s quest for improved patient safety and product quality is heavily dependent on the use of technology throughout its business processes. The industry and the FDA are working together to optimize the process through which systems and technologies are validated. ... Learn how USDM can help you adopt …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]. …USDM Life Sciences Overview. 3.8 ★. Work Here? Claim your Free Employer Profile. www.usdm.com. Santa Barbara, CA. 201 to 500 Employees. 3 Locations. Type: Company - Private. Founded in 1999. …Jan 17, 2024 · Having extensive experience with eSignature vendors, AI-enabled signatures, and regulatory compliance, USDM Life Sciences enables your organization to streamline eSignature workflows and efficiency. Examples of AI-supported services that USDM uses to reduce manual efforts and ensure that eSignature processes comply with industry-specific ... Water is essential for human life, and the taste of water can vary depending on various factors. One of the most desirable tastes of water is sweetness. Sweeter water is not only m...Mar 5, 2024 · 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. The final US UDI deadline will have passed (24 September 2022). The initial EU MDR/IVDR UDI label and package requirement deadline has also passed (MDR-complaint implantable and class III devices were 26 May 2021). More MDR and IVDR deadlines are fast approaching (e.g., MDR complaint Class IIa/b devices is 26 May 2023).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 …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 …
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USDM Life Sciences provides strategy and compliant technology solutions to regulated life sciences companies and makes it easy to accelerate transformation and innovation. USDM focuses exclusively ... USDM Life Sciences is a leading global consulting firm focused on life sciences. We specialize in regulated business processes, with an emphasis on compliance and performance. USDM Life Sciences provides innovative services and solutions that enable life science companies to achieve and maintain compliance across the entire enterprise. When was USDM founded? USDM was founded in 1999 · Who is USDM's CEO? USDM's CEO is Kevin Brown · How much revenue does USDM generate? USDM generates $9.8M in&...With a comprehensive understanding of this factor, California-based, USDM Life Sciences (USDM) has excelled at providing consulting services to help life sciences companies implement technologies in a compliant and cost … Microsoft and USDM Life Sciences enable regulated businesses to transform their GxP workflows into the cloud with USDM’s Cloud Assurance for the Microsoft Azure Platform. Your business depends on every layer of your technology to comply with FDA and global regulations for software assurance. From your infrastructure to data centers to the ... 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 …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.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... Hovsep also leads USDM’s Veeva services practice. He has nearly 20 years of experience managing projects and programs in the life sciences industry, with a specific focus on the implementation and optimization of enterprise SaaS systems, strategic consulting for C-Suite and Executive leadership, and Business & Digital Transformation in the ... USDM Life Sciences solves IT and Regulatory problems for Medical Device, Pharmaceutical and Biotechnology companies. Learn more today! 2024 Trends in Life Sciences - Learn about five trends fueling the industry | Whitepaper. Download Now. Search. Search. US: (888) 231-0816. [email protected]. Linkedin. Create an account; …USDM Life Sciences can facilitate the configuration and qualification of SharePoint for GxP document management and quality management solutions, increase your organization’s efficiency, and make you more competitive. Your first step in this process is to determine if the SharePoint instance requires validation, so be sure that …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 …Feb 20, 2024 · USDM plays on the edge of technology and science- working with leading life sciences companies from emerging and fast growing biotech to 100 year old established multi billion medical device and partners including Google, Veeva, Microsoft, Oracle and many more- addressing the challenges of using their technology to speed products to market or ... With USDM Cloud Assurance You Can: All the functionality, none of the validation burdens, in one simplified web app. Always-On, total transparency to your IT systems state of compliance. Trusted solution by hundreds of Life Science organizations. Faster implementation and integration to maximize the ROI of your technology.SANTA BARBARA, CALIFORNIA — (August 9, 2023) – USDM Life Sciences, a premier technology consulting firm focused on innovation and regulatory compliance, is thrilled to announce the return of Holger Brämer to its executive team. Having previously founded USDM Europe in 2017, Holger will be stepping into the role of … How ZenQMS + USDM can support your ZenQMS GxP Compliance. ZenQMS delivers a cloud-based eQMS platform purpose-built for life sciences organizations and designed for 21 CFR Part 11 / Annex 11 and relevant GxP/ ISO requirements from the ground up. The tool is easy to configure, validate and use, and it automates and enforces quality workflows ... 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 ….