T rained in Computer System Validation in England, Data Integrity and Data Management in Denmark, and SAP® validation in Germany, Silvia Martins develops specific projects for ERP management systems, DMS, CRM, and implements validation projects pertaining to factory floor production systems involving autoclaves, reactors, environmental monitoring, PW, WFI and quality control labs, among many others. An expert in management and automation systems, following the guidelines of FDA 21 CFR Part11, and Good Automated Manufacturing Practices Guide (GAMP5®), Silvia has given GAMP5® training for International Society for Pharmaceutical Engineering (ISPE) Brazil, coordinating the group that prepared the Guide for Computerized Systems Validation of the National Health Surveillance Agency (ANVISA), and has taught training courses for its inspectors and other state and municipal regulatory agencies, as well as having participated as a collaborator in projects developed by these institutions and industry trade associations.

Mrs. Silvia Martins is CEO, Co-Founder at Five Validation LLC.