21 CFR Part 11

Eolus® Compliance Solutions Electronic Records

Eolus has extensive experience helping our clients to understand and comply with Electronic Records & Electronic Signatures regulations. Our consultants stay abreast with the latest FDA guidance. Our services range in scope from Audits, Training, Risk Assessments, Software Evaluations, Project Planning & Management, to Software Validation projects to ensure compliances of applications and infrastructure.

Industry Activities

Eolus' expertise is recognized in the life science industries. Eolus consultants have actively participated in many related activities through our affiliation with several industry organizations such as PDA, DIA, SQA, Triangle PEERS, Barnett, and others. Eolus advises and contributes regularly on 21 CFR Part 11 and HIPAA compliance through participation in committees, task groups, conferences, presentations and published papers.

21 CFR Part 11 Resources

Affiliations

PDA (Parenteral Drug Association) 21 CFR Part 11 Task Group (Core Team Member)

PDA's Good Practice and Compliance for Electronic Records and Signatures Part 1, Good Electronic Records Management (GERM)
This document was produced through the collaboration of several industry groups (FDA regulated companies, system suppliers, legal experts, and consultants). It represents a compendium of current thinking on good electronic record management from an FDA regulated industry perspective.

Published Papers

21 CFR Part 11: Electronic Records. A Case Study for Success
Online ISSN: 1099-1786 Print ISSN: 1087-8378 The Quality Assurance Journal Volume 6, Issue 2, 2002. Copyright © 2002 John Wiley & Sons, Ltd.

Presentations

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