DV Informatica
DV Informatica
Govern regulatory risk and ensure business continuity.
In a highly regulated sector, we provide the methodological expertise necessary to pass inspections by regulatory bodies and protect corporate assets under any conditions.
We provide top-level CSV consulting services for systems in GMP (Good Manufacturing Practice) and GCP (Good Clinical Practice) environments. Based on a "Risk-Based" approach and following GAMP 5 guidelines, we draft Validation Master Plans, test protocols (IQ, OQ, PQ), and final reports. We ensure that the IT infrastructure and laboratory software (LIMS, ELN, ERP) are strictly validated and constantly in a state of "Audit Readiness", protecting patient health and product quality.
We support management in the creation, testing, and maintenance of Business Continuity Plans (BCP) and specific IT Disaster Recovery plans. We identify critical processes and implement strategies to ensure operational resilience in the face of unexpected events. At the executive level, we also provide vertical expertise for budget data analysis and reporting, implementing management control models that optimize costs and improve financial performance.
