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.

- 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.

- 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.

- 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.