Eolus® Compliance Solutions - Library Links


 

Applicable Regulations and Guidelines

 

21 CFR Part 11 Electronic Records and Signatures

General Principles of Software Validation; Final Guidance for Industry and FDA Staff 

Glossary of Computerized System and Software Development Terminology 

Guidance for Industry Computerized Systems Used in Clinical Trials

Guidance for Industry Quality Systems Approach to Pharmaceutical 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

Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach; A Science and Risk-Based Approach to Product Quality Regulation Incorporating an Integrated Quality Systems Approach (FDA 2002)

Prescription Drug Marketing Act (PDMA)

 


Publications

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.

Presentations

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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