Usdm life sciences
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 ...
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 …
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; …In the life sciences industry, IoT improves healthcare and patient support. IoT devices enable access to real-time device diagnostics and data sharing to help healthcare providers understand device performance. Patient diagnostics are obtained from personal healthcare records and devices like fitness apps and remote monitors.USDM Life Sciences provides expert assessments and value-driven roadmaps to identify critical business needs and enable your organization to improve its data, application, and technology capabilities. This includes documenting your processes, procedures, and business requirements and working together to prioritize systems, …It’s purpose-built for life sciences and meets requirements for 21 CFR Part 11, Annex 11, and relevant GxP requirements. How USDM Can Help. With more than 23 years of experience in the life sciences industry, o ur expertise is why companies trust us to achieve their quality and cost objectives. USDM Integrated GxP Compliance is more …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 …
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.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 …USDM has decades of experience helping startup and emerging life sciences companies to: Decrease the cost to maintain a continuously compliant tech stack with USDM Cloud Assurance TM . We also deliver defensible annual vendor audit reports for systems like Veeva, DocuSign, Box, Oracle, and SharePoint .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 ...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.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 ...
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 … USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender ... 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 ...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.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.
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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, …USDM may refer to: United States Death Metal · United States domestic market · Sammarinese Union of Moderates · Disambiguation icon.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 ...27 Jul 2015 ... USDM Life Sciences•204 views · 25:27. Go to channel · 21 CFR Part 11 | Electronic Records & Electronic Signatures | GxP Computer System ...He has led projects & delivered solutions for Life Sciences including complex integrations for Supply Chain & Clinical Systems. A former solution architect and ERP integrator at Oracle, he is now a certified PMP with an excellent track record of project delivery including validations. Alex leads the Oracle Practice at USDM since 2019.USDM Life Sciences is the industry leader in UDI & MDR regulatory compliance solutions for the medical device industry. We have well-established relationships with the most prominent IT vendors in the world. Additionally, our experienced team of subject matter experts is led by Jay Crowley, who developed the framework and …
Lisa Om is the Vice President of Marketing and Communications at USDM Life Sciences, where… · Experience: USDM Life Sciences · Education: University of Colorado · Location: Denver ...27 Jul 2015 ... USDM Life Sciences•204 views · 25:27. Go to channel · 21 CFR Part 11 | Electronic Records & Electronic Signatures | GxP Computer System ...Cellular therapy products are regulated under 21 CFR Part 1271, 21 CFR Part 600, and 21 CFR Part 610. Drug manufacturing requirements in 21 CFR Part 211 and 212 also apply. Because of this, cellular products have unique concerns. One challenge is the reproducibility of product lots. Because your starting material for manufacture is …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) …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; …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 …In today’s fast-paced world, where efficiency and productivity are highly valued, typing skills have become increasingly important. Regular typing practice offers numerous benefits...2 May 2014 ... USDM Life Sciences is a leading global regulatory consulting firm providing compliance, validation, qualification, quality, auditing and ...Enable an end-to-end holistic approach to ALM using ProcessX. Application lifecycle management (ALM) oversees the initial planning and development of a software application. It involves testing and maintenance while the application is in use and creating a plan for decommissioning and retirement. Contact us to schedule a demo!Computer System Validation (CSV) for life sciences professionals new to the industry. Feedback from our Forward-Thinking GxP Compliance & Process Optimization event in January indicated that many in the industry wanted to learn the fundamentals of CSV. David Blewitt fulfills that request. CSV is the process of testing and validating or qualifying …Box and USDM Life Sciences provide an innovative approach for maintaining GxP compliance in the cloud. Life sciences organizations can now create, collaborate, …
USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender ...
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 …11 Aug 2015 ... Tips for Successful Life Science Projects, Programs and Portfolio Management. 408 views · 8 years ago ...more. USDM Life Sciences. 489. 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 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 …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 …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 reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. COMPENSATION. Salary/Hourly Rate Range (W2): USD 65.00 - 120.00. The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position.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 ...To submit a lead to USDM Life Sciences, please provide us with contact information and background on the client’s needs. If you have any technical questions about how to submit a lead, please email us at [email protected]. Thanks for working with us. Enter your information in the form.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 …
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2 May 2014 ... USDM Life Sciences is a leading global regulatory consulting firm providing compliance, validation, qualification, quality, auditing and ...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 …California-based, USDM Life Sciences (USDM) has excelled at providing consulting services to help life sciences companies implement technologies in a compliant and cost-effective way. For the last 20 years, USDM has been successfully enabling life sciences companies to digitally transform while reducing compliance burdens with their qualified …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 …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).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 … 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. 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 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 …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. 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 ... 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 ... 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 ... 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 ... 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.Box and USDM Life Sciences provide an innovative approach for maintaining GxP compliance in the cloud. Life sciences organizations can now create, collaborate, manage and distribute information with their employees and partners, including CROs and CMOs, all backed by enterprise grade security and compliance. All content, regulated and non … 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, 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 ..., 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. , Cellular therapy products are regulated under 21 CFR Part 1271, 21 CFR Part 600, and 21 CFR Part 610. Drug manufacturing requirements in 21 CFR Part 211 and 212 also apply. Because of this, cellular products have unique concerns. One challenge is the reproducibility of product lots. Because your starting material for manufacture is …, USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender ... , Streamlining Oracle Clinical One Software Releases. Discover how the team of experts at USDM simplified release management for a clinical research firm. 0. Alex Sanchez. - August 15, 2023. Case Studies. CRO. Information Technology. A collection of professional case studies relating to topics in the life sciences industry., 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 …, At USDM Life Sciences, our purpose is to bring clarity and action to the interplay of technology and regulations to help biotech, pharma, and medical device companies deliver trailblazing outcomes. We help our customers use cutting-edge technology to increase their speed to market while ensuring continuous compliance and …, Google Cloud for Healthcare & Life Sciences is evolving the care paradigm, advancing research at scale, and allowing the industry to innovate and transform, and USDM Life …, 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. , Box and USDM Life Sciences provide an innovative approach for maintaining GxP compliance in the cloud. Life sciences organizations can now create, collaborate, …, At USDM Life Sciences, our purpose is to bring clarity and action to the interplay of technology and regulations to help biotech, pharma, and medical device companies deliver trailblazing outcomes. We help our customers use cutting-edge technology to increase their speed to market while ensuring continuous compliance and …, 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 ..., 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 (also known as US Data Management) is a technology consulting firm. It offers regulatory compliance, digital transformation, and cloud assurance solutions. The …, 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..., 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..., 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 …, 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 …, 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 …, 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..., 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]. …, 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..., 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, …, 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..., Say Hello to RPA. Robotic Process Automation (RPA) is software that acts like a robot (bot) to emulate how humans interact with digital systems to execute routine or repetitive business tasks. As the concept of RPA evolves, artificial intelligence (AI) can help automate complex processes and tasks, allowing AI robots to go from “execution ..., USDM Life Sciences, Leading Life Sciences Firm, Expands Manufacturing Systems Services, Hires Wilfredo Santiago As Senior Manager SANTA BARBARA, CA--(Marketwired - December 10, 2013) -, 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 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 …, Michael brings over 33 years of life sciences industry experience, ... Prior to joining USDM, he was with EMC for five years as the Practice Manager, Life Sciences Compliance and Risk Management providing IT risk and quality management services and solutions., USDM may refer to: United States Death Metal · United States domestic market · Sammarinese Union of Moderates · Disambiguation icon., Erin Christy leads USDM’s Emerging Life Sciences division, which focuses on helping start-up biotech, pharma, medical device, and medical cannabis and cannabinoid companies establish their regulatory …, 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 …, 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 ...