USDM

Having access to Subject Matter Experts (SMEs) on staff is crucial for maintaining US Data Management's (USDM) leadership and competitive edge in the regulatory compliance consulting services arena.

Our SMEs are industry leaders that have accrued significant experience and depth of knowledge in particular business areas, complemented with solid regulatory compliance acumen.

Following are examples of domains of interest to USDM SMEs:

• Software development lifecycle
• Change control and configuration management
• Quality assurance, control and auditing
• Risk-based compliance approaches
• Project and resource management
• Process control and automation
• Analysis, reengineering and improvement of business processes
• Laboratory and sample management processes
• Pharmacovigilance
• Learning management
• Pre-clinical and clinical trial-related processes
• Electronic document management
• Workflow automation

 Our SMEs are well versed in cGXPs, relevant FDA regulations (e.g., 21 CFR Parts 11, 58, 210, 211, 610 and 820, among many others), and industry-standard approaches proposed by GAMP and ISO; in addition to ample experience developing strategies for bringing regulatory compliance projects to completion and producing supporting documentation suites capable of withstanding FDA audits.

To learn more about USDM and how we can assist with your compliance and business objectives, please contact:

Rebecca Meledy
888.231.0816 x161
775.213.5943 (fax)
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"Simplify, Unify and Optimize your business & compliance needs with USDM"