US Data Management, LLC

PROCESS X

Downloadable software for managing, gathering, organizing, and sharing data, information and images in the life sciences fields, for use in life sciences and manufacturing companies to access, search, create, edit, modify, collaborate, categorize, organize, control, store, manage, validate, retrieve, archive, deliver, publish, track, analyze, report and view data, documents, images and other electronic content in the fields of quality assurance and management, quality control, manufacturing quality, quality guidelines and regulations, manufacturing quality, clinical practice regulations, and laboratory practice regulatory compliance, process automation, customer experience, supplier management, information technology infrastructure, non-conformance deviation, open source and over-the-top applications, corrective and preventative action management, change management, audit findings response, supplier correction requests, human resources, information technology, procurement, legal, research and development, clinical, manufacturing and distribution, post-market surveillance and all quality guidelines and regulations and artificial intelligence-infused risk management and regulatory compliance and related non-quality guidelines and regulations purposes;PROCESS;

PROCESSX

Software as a service (SAAS) services featuring software for managing, gathering, organizing, and sharing data, information and images in the life sciences fields, for use in life sciences and manufacturing companies to access, search, create, edit, modify, collaborate, categorize, organize, control, store, manage, validate, retrieve, archive, deliver, publish, track, analyze, report and view data, documents, images and other electronic content in the fields of quality assurance and management, quality control, manufacturing quality, quality guidelines and regulations, manufacturing quality, clinical practice regulations, and laboratory practice regulatory compliance, process automation, customer experience, supplier management, information technology infrastructure, non-conformance deviation, open source and over-the-top applications, corrective and preventative action management, change management, audit findings response, supplier correction requests, human resources, information technology, procurement, legal, research and development, clinical, manufacturing and distribution, post-market surveillance and all quality guidelines and regulations and artificial intelligence-infused risk management and regulatory compliance and related non-quality guidelines and regulations purposes; platform as a service (PAAS) featuring computer software platforms for managing, gathering, organizing, and sharing data, information and images in the life sciences fields, for use in life sciences and manufacturing companies to access, search, create, edit, modify, collaborate, categorize, organize, control, store, manage, validate, retrieve, archive, deliver, publish, track, analyze, report and view data, documents, images and other electronic content in the fields of quality assurance and management, quality control, manufacturing quality, quality guidelines and regulations, manufacturing quality, clinical practice regulations, and laboratory practice regulatory compliance, process automation, customer experience, supplier management, information technology infrastructure, non-conformance deviation, open source and over-the-top applications, corrective and preventative action management, change management, audit findings response, supplier correction requests, human resources, information technology, procurement, legal, research and development, clinical, manufacturing and distribution, post-market surveillance and all quality guidelines and regulations and artificial intelligence-infused risk management and regulatory compliance and related non-quality guidelines and regulations purposes; Infrastructure as a service (IAAS) services, namely, hosting software for managing, gathering, organizing, and sharing data, information and images in the life sciences fields, for use in for life sciences and manufacturing companies to access, search, create, edit, modify, collaborate, categorize, organize, control, store, manage, validate, retrieve, archive, deliver, publish, track, analyze, report and view data, documents, images and other electronic content in the fields of quality assurance and management, quality control, manufacturing quality, quality guidelines and regulations, manufacturing quality, clinical practice regulations, and laboratory practice regulatory compliance, process automation, customer experience, supplier management, information technology infrastructure, non-conformance deviation, open source and over-the-top applications, corrective and preventative action management, change management, audit findings response, supplier correction requests, human resources, information technology, procurement, legal, research and development, clinical, manufacturing and distribution, post-market surveillance and all quality guidelines and regulations and artificial intelligence-infused risk management and regulatory compliance and related non-quality guidelines and regulations purposes;

UNIFY COMPLIANCE CLOUD

Business and IT training services in the life sciences fields for quality assurance workflows, processes and workflows related to regulated content management, document management, change management, information technology implementation, validation, compliance maintenance and management of cloud SaaS system updates for all bundled technology;Business consulting services in the life sciences fields pertaining to customized processes and workflows related to regulated content management, document management and change management;COMPLIANCE CLOUD;IT consulting services in life sciences fields pertaining to information technology implementation, validation, compliance maintenance and management of cloud SaaS, PaaS and IaaS compliance system updates for single vendor technology stacks;

UNIFY PUBLIC CLOUD

Business and IT training services in the life sciences fields for quality assurance workflows, processes and workflows related to regulated content management, document management, change management, information technology implementation, validation, compliance maintenance and management of cloud SaaS, PaaS and IaaS compliance system updates for single vendor technology stacks;Business consulting services in the life sciences fields pertaining to customized processes and workflows related to regulated content management, document management and change management;PUBLIC CLOUD;IT consulting services in life sciences fields pertaining to information technology implementation, validation, compliance maintenance and management of cloud SaaS, PaaS and IaaS compliance system updates for single vendor technology stacks;

USDM

Providing educational programs in the life science fields using on-line activities, non-downloadable webinars and blogs, workshops, and printable materials distributed therewith featuring Regulatory issues and developments, GxP (Good Practice) Compliance, Risk Management, Design Control, QMS (Quality Management Solutions), CSV (Computer System Validation), SOP (Standard Operating Procedures), Data Integrity, UDI (Unique Device Identification), Regulatory readiness, and other related practice areas in the life sciences fields;US DATA MANAGEMENT;Business advisory, development, and strategic planning services provided to companies for business purposes in the life sciences industries; Business consultation services in the field of GxP (Good Practice) compliance; Business consulting services on processes and workflows related to content creation, localization and publishing strategy including Translation Memory and Terminology Management, Quality Management, Life Sciences Regulatory Compliance and Risk Management; Business consulting and management in the field of clinical trials, namely, clinical data and regulatory submission management on behalf of medical, biopharmaceutical and biotechnology companies to assist them with clinical research, clinical trials and applications for drug approval; Regulatory submission management, namely, assisting others in preparing and filing applications for new medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology with governmental regulatory bodies around the world; Regulatory submission management, namely, providing simultaneous multiple country submissions of applications for the registration and approval of medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology; providing information online regarding regulatory submission management; Business management consulting, strategic planning and business advisory services provided to medical, medical technology, biopharmaceutical, and biotechnology companies, and government agencies, educational and research institutions, law firms, and investment firms in the fields of biologics, pharmaceuticals and medical devices; Providing consulting services in the field of regulatory submission management to medical companies to assist them with applications for drug and medical device approval; Regulatory submission management, namely, assisting others in preparing and filing applications for new drugs and medical devices with governmental regulatory bodies; Business consulting services in the field of biologics, pharmaceuticals, prescription drugs and medical devices; Business consulting and management for companies in the life sciences fields pertaining to business operations including standard operating procedures, audits and assessments; Business consulting and for companies in the life sciences fields related to supply chain management, including, internet of medical things (IoMT), connected service and quality management, product lifecycle management, product master management, and enterprise resource planning; Providing IT staffing services for companies in the life sciences fields and employment consultation pertaining to staffing augmentation services and onsite and remote on-demand compliance staff augmentation; Business consulting and management for companies in the life sciences fields pertaining to business operations including information and data compiling and analyzing relating to business management; consulting services in the field of medical device product approval for commercial purposes;Regulatory compliance consulting services in the life sciences fields, namely, reviewing standards and practices to assist clients with compliance with governmental laws, regulations and rules pertaining to medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology; providing technical regulatory affair consulting services directed to medical, medical technology, biopharmaceutical, and biotechnology companies in order to assure compliance with food and drug administration's laws and regulations; provision of information online pertaining to regulatory compliance in the fields of medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology; and regulatory compliance consulting in the fields of biologics, pharmaceuticals, prescription drugs and medical device;Consulting services in the fields of biotechnology, pharmaceutical research and development and genetic science; biotechnology research consulting services; pharmaceutical research and product development for use in manufacturing; information technology consultation services; computer aided design services; Consulting services for others in the field of designing pre-clinical and clinical studies and trials for others; product research and development for others in the fields of biologics, pharmaceuticals, prescription drugs and medical devices; quality management services, namely, quality evaluation and analysis, quality assurance and quality control in the field of biologics, pharmaceuticals, prescription drugs and medical devices; scientific consulting and research services relating to the field of pharmaceuticals, medical devices, and life sciences, namely, biology, and medicine; design and development and technical verification consulting services in the fields of biotechnology and pharmaceutical research, and scientific and technological services, namely, scientific research, analysis, testing, and related scientific studies in the field of chemistry and molecular biology, namely, biologics and protein detection, characterization, analysis and testing; Computer consulting services in the field of cloud computing in the field of life science; Technical and scientific research consulting and computer project management for companies in the life sciences fields pertaining to cloud-based data migration; Technical and scientific consulting and management for companies in the life sciences fields pertaining to technical verification and validation laboratory equipment and instrumentation; Technical and scientific consulting and management for companies in the life sciences fields for digital purposes, including digital compression of computer data; Technical and scientific consulting and management for companies in the life sciences fields for cloud computing purposes, including GxP (Good Practice) cloud seeding services;

USDM CLOUD ASSURANCE

Providing educational and informational content and customized training materials and programs in the life science fields through various print and electronic multimedia, including: videos, blogs, articles, webinars, white papers, onsite/offsite remote channels, workshops, hands-on training programs, and other training environments in the life sciences fields, including but not limited to the following subject matter: end-to-end GxP (Good Practice) cloud compliance from implementation through ongoing validation maintenance of new releases; product data integration into a modern Quality Management System (QMS) to create more efficient workflows; clinical collaboration in a GxP compliant environment; Computer Systems Validation (CSV); document management systems; enterprise content management systems; workflow and eSignature approval streamlining; digital transformation strategy and roadmapping and application consolidation, including email, document management, file transfer protocol (FTP) servers and file share drives; merger and acquisition standardization and harmonization; GxP compliance for FDA audits, EU audits, and other regulatory agencies; reducing implementation and validation time; harmonizing and centralizing GxP cloud compliance; cost reduction for managing cloud compliance; new release management for continuous cloud compliance; scalable vendor solutions for establishing compliant IT foundations; vendor audits targeted to current processes, technology, and manufacturing; implementation and validation of GxP compliant changes, including regulatory assessment, creation of validation plans and reports, drafting of user requirements and functional specifications, risk and impact assessment, developing IQ/OQ/PQ protocols and test scripts, developing user and administration SOPs; continuous GxP compliance, including managing new vendor releases, conducting impact assessments, updating validation documents, running automated regression tests, and providing continuous analysis and reporting;UNITED STATES DATA MANAGEMENT CLOUD ASSURANCE;Advisory, development, and strategic planning services provided to companies for business purposes in the life sciences industries; Business consultation services in the life sciences fields featuring: end-to-end GxP (Good Practice) cloud compliance from implementation through ongoing validation maintenance of new releases; product data integration into a modern Quality Management System (QMS) to create more efficient workflows; clinical collaboration in a GxP compliant environment; Computer Systems Validation (CSV); document management systems; enterprise content management systems; workflow and eSignature approval streamlining; digital transformation strategy and roadmapping and application consolidation, including email, document management, file transfer protocol (FTP) servers and file share drives; merger and acquisition standardization and harmonization; GxP compliance for FDA audits, EU audits, and other regulatory agencies; reducing implementation and validation time; harmonizing and centralizing GxP cloud compliance; cost reduction for managing cloud compliance; new release management for continuous cloud compliance; scalable vendor solutions for establishing compliant IT foundations; vendor audits targeted to current processes, technology, and manufacturing; implementation and validation of GxP compliant changes, including regulatory assessment, creation of validation plans and reports, drafting of user requirements and functional specifications, risk and impact assessment, developing IQ/OQ/PQ protocols and test scripts, developing user and administration SOPs; continuous GxP compliance, including managing new vendor releases, conducting impact assessments, updating validation documents, running automated regression tests, and providing continuous analysis and reporting;CLOUD ASSURANCE;

USDM LIFE SCIENCES

Providing educational programs in the life science fields using on-line activities, non-downloadable webinars and blogs, workshops, and printable materials distributed therewith featuring Regulatory issues and developments, GxP (Good Practice) Compliance, Risk Management, Design Control, QMS (Quality Management Solutions), CSV (Computer System Validation), SOP (Standard Operating Procedures), Data Integrity, UDI (Unique Device Identification), Regulatory readiness, and other related practice areas in the life sciences fields;UNITED STATES DATA MANAGEMENT LIFE SCIENCES;Business advisory, development, and strategic planning services provided to companies for business purposes in the life sciences industries; Business consultation services in the field of GxP (Good Practice) compliance; Business consulting services on processes and workflows related to content creation, localization and publishing strategy including Translation Memory and Terminology Management, Quality Management, Life Sciences Regulatory Compliance and Risk Management; Business consulting and management in the field of clinical trials, namely, clinical data and regulatory submission management on behalf of medical, biopharmaceutical and biotechnology companies to assist them with clinical research, clinical trials and applications for drug approval; Regulatory submission management, namely, assisting others in preparing and filing applications for new medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology with governmental regulatory bodies around the world; Regulatory submission management, namely, providing simultaneous multiple country submissions of applications for the registration and approval of medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology; providing information online regarding regulatory submission management; Business management consulting, strategic planning and business advisory services provided to medical, medical technology, biopharmaceutical, and biotechnology companies, and government agencies, educational and research institutions, law firms, and investment firms in the fields of biologics, pharmaceuticals and medical devices; Providing consulting services in the field of regulatory submission management to medical companies to assist them with applications for drug and medical device approval; Regulatory submission management, namely, assisting others in preparing and filing applications for new drugs and medical devices with governmental regulatory bodies; Business consulting services in the field of biologics, pharmaceuticals, prescription drugs and medical devices; Business consulting and management for companies in the life sciences fields pertaining to business operations including standard operating procedures, audits and assessments; Business consulting and for companies in the life sciences fields related to supply chain management, including, internet of medical things (IoMT), connected service and quality management, product lifecycle management, product master management, and enterprise resource planning; Providing IT staffing services for companies in the life sciences fields and employment consultation pertaining to staffing augmentation services and onsite and remote on-demand compliance staff augmentation; Business consulting and management for companies in the life sciences fields pertaining to business operations including information and data compiling and analyzing relating to business management; consulting services in the field of medical device product approval for commercial purposes;Regulatory compliance consulting services in the life sciences fields, namely, reviewing standards and practices to assist clients with compliance with governmental laws, regulations and rules pertaining to medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology; providing technical regulatory affair consulting services directed to medical, medical technology, biopharmaceutical, and biotechnology companies in order to assure compliance with food and drug administration's laws and regulations; provision of information online pertaining to regulatory compliance in the fields of medical devices, medical technologies, medications, biopharmaceuticals, and biotechnology; and regulatory compliance consulting in the fields of biologics, pharmaceuticals, prescription drugs and medical devices;LIFE SCIENCES;Consulting services in the fields of biotechnology, pharmaceutical research and development and genetic science; biotechnology research consulting services; pharmaceutical research and product development for use in manufacturing; information technology consultation services; computer aided design services; Consulting services for others in the field of designing pre-clinical and clinical studies and trials for others; product research and development for others in the fields of biologics, pharmaceuticals, prescription drugs and medical devices; quality management services, namely, quality evaluation and analysis, quality assurance and quality control in the field of biologics, pharmaceuticals, prescription drugs and medical devices; scientific consulting and research services relating to the field of pharmaceuticals, medical devices, and life sciences, namely, biology, and medicine; design and development and technical verification consulting services in the fields of biotechnology and pharmaceutical research, and scientific and technological services, namely, scientific research, analysis, testing, and related scientific studies in the field of chemistry and molecular biology, namely, biologics and protein detection, characterization, analysis and testing; Computer consulting services in the field of cloud computing in the field of life science; Technical and scientific research consulting and computer project management for companies in the life sciences fields pertaining to cloud-based data migration; Technical and scientific consulting and management for companies in the life sciences fields pertaining to technical verification and validation laboratory equipment and instrumentation; Technical and scientific consulting and management for companies in the life sciences fields for digital purposes, including digital compression of computer data; Technical and scientific consulting and management for companies in the life sciences fields for cloud computing purposes, including GxP (Good Practice) cloud seeding services;

USDM UNIFY COMPLIANCE CLOUD

Business and IT training services in the life sciences fields for quality assurance workflows, processes and workflows related to regulated content management, document management, change management, information technology implementation, validation, compliance maintenance and management of cloud SaaS system updates for all bundled technology;US DATA MANAGEMENT UNIFY COMPLIANCE CLOUD;Business consulting services in the life sciences fields pertaining to customized processes and workflows related to regulated content management, document management and change management;COMPLIANCE CLOUD;IT consulting services in life sciences fields pertaining to information technology implementation, validation, compliance maintenance and management of cloud SaaS system updates for all bundled technology;

USDM UNIFY PUBLIC CLOUD

Business and IT training services in the life sciences fields for quality assurance workflows, processes and workflows related to regulated content management, document management, change management, information technology implementation, validation, compliance maintenance and management of cloud SaaS, PaaS and IaaS compliance system updates for single vendor technology stacks;US DATA MANAGEMENT;Business and IT consulting services in the life sciences fields, namely, customized processes and workflows related to regulated content management, document management, change management, information technology implementation, validation, compliance maintenance and management of cloud SaaS, PaaS and IaaS compliance system updates for single vendor technology stacks;