Globiox is a team of experts, many with 20+ years in FDA regulated industries providing expertise in these areas:** Quality Systems and Compliance with GxP, GMP, GCP, GLP, CLIA, and ISO. Computerized system validation, Auditing, Risk Management, Vendor Management. Specialists in TrackWise Validation and TrackWise Configuration.Globiox assists clients with investigations and remediation of OOS results and deviations. We are experts at root cause analysis and CAPA.Globiox analyzes FDA 483 observations and Warning Letters, and develops action plans to successfully address the issues concerning the FDA. We ensure that remediations are done quickly, efficiently, and with transfer of knowledge to the customer.We provide IT services for FDA-regulated companies to make computerized systems more secure, and compliant to 21 CFR Part 11.Globiox has expert capabilities in providing Quality Assurance services for clinical trials. This includes auditing and development of SOPs.Globiox's audit program can provide thorough supplier audits, GMP audits, GLP audits, GCP audits, and ISO audits.Study Director TrainingSpecialties:ValidationProcess ValidationCleaning ValidationLaboratoriesCLIA21 CFR Part 11CAPAInvestigationsOOSFDA510kQSRPMAINDSupplier audits