Kátia brings over 25 years of specialized expertise in computer system validation, quality assurance, and regulatory compliance to CLINIGMA^®. As IT QA Lead, she ensures that all technology systems supporting patient interview studies meet the highest regulatory standards while maintaining robust security and compliance frameworks.

Computer System Validation Excellence

• Master's degree in Engineering from Universidade de São Paulo with specialized focus on Digital Systems
• Extensive experience in Computer System Validation (CSV) process definition and execution following FDA regulations
• Expert in validation protocols and reports creation for systems related to pharmacovigilance, QMS, and training platforms
• Proven track record managing CSV projects for medical devices and clinical trial systems

Regulatory Compliance and Quality Management

• Over 15 years of experience implementing Quality Management Systems in pharmaceutical and medical device industries
• Expert in FDA, GMP, and SOX compliance requirements with extensive audit coordination experience
• Specialized knowledge in PMBOK, COBIT, CMMI, and IT Governance frameworks
• ISO 9001 knowledge with proven ability to implement and maintain quality standards

Information Security and Access Management

• Data Security Officer experience for Latin America with comprehensive understanding of information security frameworks
• Responsible for Access Identity Management implementation and maintenance
• Expert in Information Security policies implementation and SOX training delivery
• Proven ability to coordinate security audits and maintain compliance across international operations

Testing and Quality Assurance Leadership

• Advanced expertise in test coordination, script elaboration, and execution across unit, integration, acceptance, and regression testing
• Functional and QA testing execution with focus on pharmaceutical and medical device applications

International Experience and Multilingual Capabilities

• Understanding of diverse regulatory requirements across multiple jurisdictions

Technology and System Development

• Strong technical background in system development and analysis with facility in technical meetings
• Experience with ERP systems (JDE), SAP PI, Business Intelligence tools, and various database platforms
• Knowledge of SDLC, Change Management, and Computer System Validation methodologies

Pharmaceutical Industry Specialization

• Extensive experience with pharmacovigilance systems and regulatory compliance requirements
• Understanding of clinical trial technology requirements and validation needs
• Proven track record in medical device development projects and regulatory submissions
• Experience with automation systems in healthcare and pharmaceutical environments

Kátia's comprehensive background in computer system validation, regulatory compliance, and international project management ensures that CLINIGMA^®'s technology infrastructure exceeds pharmaceutical industry standards. Her proven ability to implement robust quality systems while maintaining operational efficiency makes her an essential asset for delivering compliant, secure, and reliable technology solutions for patient interview studies.

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