DH2Consulting, LLC

Define and assess critical Quality business processes and computer systems used to accelerate the release of products to patients. Can provide analysis to balance operational support of installed systems with the implementation of system improvements or the replacement of critical systems due to obsolescence or changing business needs. Develop strategies to accelerate the standardization and harmonization of global systems to reduce cost, simplify user experience, and/or decrease health authority inspection durations. Leverage risk-based approach to computer system validation. Assess compliance gaps and develop mitigation strategies.