Orlando López

A highly skilled and detail-oriented subject matter expert in data reliability, bringing 30 years of extensive experience in ensuring data accuracy, reliability, and security.
 

His recent publications are available at https://www.routledge.com/authors/i8734-orlando-lopez, https://novapublishers.com/shop/e-records-integrity-requirements/, https://tinyurl.com/LifecycleIntegrity, and https://tinyurl.com/MachineLerning.
 

He has successfully developed and deployed methodologies for e-compliance, CSV, and disaster recovery that are applicable across various domains, including computer infrastructure (J&J ITCS), big data analytics (Lilly), cell therapy clinical facility instrumentation (Catalent), and machine learning (ML) systems. His track record demonstrates a strong commitment to regulatory compliance, as evidenced by successful inspections by the FDA and EU, with no observations noted in the projects he has managed. In addition, he has contributed over 49 publications to the field, including 16 esteemed books focused on computer compliance.
 

Experience:
 

  • Data reliability (DR), quality, and control subject matter expert specializing in data management, framework, and risk assessment.
  • In-depth knowledge of data governance principles, data quality standards, and regulatory compliance requirements (e.g., medicinal products manufacturing).
  • In-depth knowledge of machine learning eCompliance.