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Selected Applicable Regulations and Guidelines


21 CFR Part 11 Electronic Records and Signature

Guidance for Industry Computerized Systems Used in Clinical Investigations

Guidance for Industry Quality Systems Approach to Current Good Manufacturing Practice Regulations

Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices

Guidance for Industry, Part 11, Electronic Records and Signatures - Scope and Application

General Principles of Software Validation

Health Insurance Portability and Accountability Act

ICH Guideline for Good Clinical Practice




PDA's Good Practice and Compliance for Electronic Records and Signatures Part 1, Good Electronic Records Management (GERM)
Core PDA Committee Participant/Co-Author: Phyllis Weldon. 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.

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


A Project Management Approach to Compliance Author and Presenter: Phyllis M. Weldon

A Case Study for Success Author and Presenter: Phyllis M. Weldon


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