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Journal of Materials Science and Nanotechnology | Volume: 2
August 20-21, 2018 | Paris, France
Materials Science and Materials Chemistry
International Conference on
GxP/GMP and its consequences for documentation and information technology systems
Eleonora Babayants
Galaxy Consulting, USA
D
ocumentation is a critical tool for ensuring GxP/GMP
compliance. This is what GMP states about document
control: each manufacturer shall establish and maintain
procedures to control all documents that are required. In the
regulated environment which must be GxP/GMP compliant,
document control is the cornerstone of the quality system. It
is so important that if an external audit identifies deficiencies
in the document control system, the entire organization
can be shut down.There are also GMP requirements for
information technology. For a drug to be produced in a GxP/
GMP compliant manner, some specific information technology
practices must be followed. Computer systems involved in the
development, manufacture, and sale of regulated product
must meet certain requirements. Change control within quality
management systems (QMS) and information technology
(IT) systems is a formal process used to ensure that changes
to a product or system are introduced in a controlled and
coordinated manner. In the regulated industries, manufactures
are required to use a change control procedure. In this
workshop, we will discuss the connection between GxP/GMP
and document control. We will describe details of document
control procedures, and the role of Quality Assurance in the
documentation systems. We will review GMP requirements for
information technology and how computer systems including
documentation management systems must meet GxP/GMP
requirements. We will also review change control procedure
and how it should be used in GxP/GMP environment.
Speaker Biography
Galaxy Consulting Founder and President Eleonora Babayants is a documentation
management professional and hands-on consultant 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. Eleonora’s 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 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 documents templates.
Eleonora’s experience spans multiple industries including biomedical, pharmaceutical and
medical devices companies.
e:
eleonora@galaxyconsulting.net