Electronic Records Management in Compliance with FDA Regulations

Electronic Records Management in Compliance with FDA Regulations

GxP/GMP regulations are required to be used in regulated industries such as food, pharmaceutical, medical devices, and cosmetics. Good Documentation Practice, commonly abbreviated as GDocP, is the standard in the regulated industries by which documents and records should be created and maintained. GDocP is aligned with GxP/GMP regulations.

IT systems are used to support various regulated activities, which in turn generate many types of electronic records. These electronic records must be maintained according to regulatory requirements contained within FDA’s 21 CFR Part 11, commonly abbreviated as Part 11, for US and Annex 11 for European Union. One of the requirements for such compliance is the generation and review of audit trails.

Documented Part 11 training is required for staff who have responsibilities within the scope of the regulation. Understanding the requirements of Part 11 is critical to compliance with the regulation.

Auditors pay particular attention to documentation and electronic records to make sure that they comply with all regulations. Documentation and electronic records are so important that if an external audit identifies deficiencies in them, the entire organization can be shut down.

Why You Should Attend:

In this webinar, the connection between GxP/GMP and documentation and electronic records will be discussed. Details of document control procedures and the role of Quality Assurance in the documentation systems will be described.

We will describe Part 11 regulation, electronic records requirements, audit trail, and electronic signatures requirements. You will learn how to secure, manage, and control documents and electronic records in compliance with regulatory requirements and will be able to pass quality audit.

Areas Covered in the Session :

  • GxP/GMP and documentation and electronic records
  • Purpose of document control
  • Controlled documents – types, identification
  • Role of QA in document control
  • Document control procedures
  • Document management system
  • Measuring success of document control system
  • 21 CFR Part 11 and European equivalent Annex 11
  • Audit trail
  • Electronic signatures
Who Should Attend:

  • Quality Assurance Departments
  • Documentation Departments
  • Compliance Departments
  • Production Departments
  • Laboratory Professionals
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • IT Departments
  • Operations Departments
  • Medical Affairs
  • Safety Managers
  • Systems & Databases Administrators
  • Record Managers

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Eleonora Babayants

Eleonora Babayants is a Galaxy Consulting Founder and President, She 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.
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