Michael Canale Email & Phone Number

Bridgewater, Nj, Us

USDM is changing how compliance is addressed for life science companies worldwide. We are committed to achieving both PERFORMANCE and COMPLIANCE from the systems that run life sciences organizations. We partner with technology vendors who lead in the life sciences sector, assimilate the technology into a adaptable model and support the proper implementation and maintenance of such systems. Our partners include Agilent, Oracle and SAP as well as many others. Our clients include emerging… Show more USDM is changing how compliance is addressed for life science companies worldwide. We are committed to achieving both PERFORMANCE and COMPLIANCE from the systems that run life sciences organizations. We partner with technology vendors who lead in the life sciences sector, assimilate the technology into a adaptable model and support the proper implementation and maintenance of such systems. Our partners include Agilent, Oracle and SAP as well as many others. Our clients include emerging biotechnology companies as well as the largest pharmaceutical players. Our team grows as quickly as we can find the rare people who can support our mission with the same passion and capability. Show less

- Directed client consulting engagements and teams for high-profile client engagements that spanned a diverse set of regulated business process applications including ERP, Quality Management, Learning Management, Document Management, Records Management, LIMS and Laboratory Systems, Device History Records, Calibration Management, Adverse Events, Complaints, Master Data Management, Clinical Data Management, Data Capture.- Responsible for professional services planning and delivery… Show more - Directed client consulting engagements and teams for high-profile client engagements that spanned a diverse set of regulated business process applications including ERP, Quality Management, Learning Management, Document Management, Records Management, LIMS and Laboratory Systems, Device History Records, Calibration Management, Adverse Events, Complaints, Master Data Management, Clinical Data Management, Data Capture.- Responsible for professional services planning and delivery including requirements analysis, workflow and solution design, configuration, SDLC documentation development, validation, test script authoring and execution, end-user training, go-live support, and application enhancements and customizations. Show less

- Quality and compliance lead responsible for developing a strategy and multi-year roadmap for ensuring robust quality and compliance with regulatory requirements for an Order-to-Cash system that spanned multiple businesses and drove consistent quality across all projects.- Validation Project Manager for the management and execution of manufacturing, laboratory, quality, and business system validation projects.

- Part 11 Compliance Oversight Lead charged with the oversight of a $180MM Part 11 remediation program roadmap that delivered sustainable Part 11 functionality and control and aligned with the corporate interpretation of the regulation.- Product Development Head for the planning and business development of for a new product line and a major investment for the building of the initial product offering and go-to-market strategy.- Validation Project Manager for the management and… Show more - Part 11 Compliance Oversight Lead charged with the oversight of a $180MM Part 11 remediation program roadmap that delivered sustainable Part 11 functionality and control and aligned with the corporate interpretation of the regulation.- Product Development Head for the planning and business development of for a new product line and a major investment for the building of the initial product offering and go-to-market strategy.- Validation Project Manager for the management and execution of manufacturing, laboratory, quality, and business system validation projects. Show less