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Eleonora Babayants


Eleonora Babayants

Galaxy Consulting, USA

Biography

Eleonora Babayants is a Galaxy Consulting Founder and President. She is a Documentation Management Professional and hands-on consulting with over 25 years of experience in documentation and records management, document control, regulatory compliance, internal and external auditing, electronic document management systems, information governance, and change management. Her past work includes development and implementation regulatory compliance processes and procedures, leading implementation and administration of document control systems in full compliance with regulatory requirements, enabling enterprise search, improving systems information architecture, creating and implementing users training programs. She has led electronic document management systems selection and deployment, administered and supported these systems, web information portals, knowledgebase applications, recommended and implemented re-structuring of the content and the information architecture of these systems. She worked very closely with IT to do feasibility assessment and to capture users’ requirements. She wrote technical documents and created document templates. Her experience spans multiple industries including biomedical, pharmaceutical, and medical devices companies.

Abstract

Abstract : Quality management and quality audit according to GxP/GMP requirements