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Additional Industry White Papers from some of today's top industry thought leaders, provide close-up look at many of the risk, compliance, and quality issues impacting businesses today.

Documents

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A Practical Method to Track Project Percentage Complete Using Earned Value Analysis A Practical Method to Track Project Percentage Complete Using Earned Value Analysis

By: Bruce Fieggen, Vice President, Project Management, QPharma, Inc. (Compliments of Pilgrim Software)
The Earned Value Project Management method is indeed a powerful tool that supports the management of project scope, time and cost (Page 12, Project Management Journal, Volume 34, Number 4 December 2003). But not many laymen understand it without some intensive training in the technique.
An important part of a consultant project manager’s job is to keep customers informed of the project’s status in terms of schedule and budget. Everyone understands what it means when a project is 2 weeks behind schedule, but most would be confused if told it is $10,000 behind schedule.
It is possible, however, to salvage some of the official earned value calculations to generate two numbers that are meaningful to customers: Percentage of the project that is complete and percentage of the budget that has been spent.
Request this white paper to learn more.

Complaint Management in the Medical Device Industry: Effectively Handling Complaints Complaint Management in the Medical Device Industry: Effectively Handling Complaints

The medical device industry is one of manufacturing's most closely regulated industries. Complaints handling is one of the industry's key regulatory issues. This paper presents the results of a survey on how companies are managing their complaints handling processes to help reduce noncompliance risks. Compliments of Compliance-Alliance

EDMS and QMS Selection and Implementation: So Many Failures, So Much Frustration EDMS and QMS Selection and Implementation: So Many Failures, So Much Frustration

The selection of an EDMS or QMS solution can be an arduous process. However, each offers features and functionality that drive business requirements and ensure compliance, providing a cost-effective and efficient solution that, if managed professionally and driven to a successful roll-out, will dramatically streamline document flow and retrieval, enable compliance, and deliver a significant positive impact to the organization's bottom line. Compliments of Maxiom Consulting Group, Inc.

FDA FAQ on Good Laboratory Practice FDA FAQ on Good Laboratory Practice

This document consolidates all GLP questions answered by the agency, clarifies the questions and answers as needed, and relates the questions and answers to the specific pertinent provisions of the GLPs. It represents a digest of some 30 letters, 160 memoranda of telephone conversations, 34 memoranda of meetings and 30 miscellaneous correspondences that have been issued by agency personnel. Compliments of EnKap

FDA GLP Inspections - A Handbook to Preparing for a Successful Inspection: Part I (Excerpt) FDA GLP Inspections - A Handbook to Preparing for a Successful Inspection: Part I (Excerpt)

This article excerpt focuses on preparing your company for an FDA inspection for nonclinical laboratory inspections. Compliments of enKap

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