Quality & Compliance Newsletter - April 2005

[Quality and Compliance]

	This is a complimentary issue of INSIGHTS. Please click to get INSIGHTS delivered free every month
April 2005

INSIGHTS

	Free webinar on "Automating the Corrective Action Process" on Wednesday, May 18, 2005 at 12 noon EDT / 9:00 am, PDT

 The Quality & Compliance Newsletter

	Supplier Quality Management in FDA-regulated Industry
	After outsourcing manufacturing to lower cost countries, many companies find new demands imposed on their quality management processes. As a result, many companies find their existing quality management systems to be no longer effective. This is especially true if their existing quality system is either paper-based or implemented using a PC-based point solution. This article identifies the quality management requirements for an outsourced manufacturing environment and explains how companies that outsource manufacturing can still maintain a clear visibility into their outsourcer?s process capability and their overall product quality.
	Full story

	Change Control in the FDA-regulated Industry
	Change control is the most critical element in a pharmaceutical or biotech company?s quality management system - inadequate change control procedures end up creating a huge risk of non-compliance. The FDA's guidance for Industry clearly reinforces the importance of implementing an effective change control procedures as a critical component in an overall quality system ? see ?Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (CGMP)?. It?s important for FDA-regulated companies to be able to implement a quality system that automates change management and change control procedures and ensures that they are in compliance with GxPs and 21 CFR Part 11.
	Full story

	Operational Benefits of Sarbanes-Oxley Compliance
	Companies are governed by a complex web of regulations, laws, voluntary codes, industry codes, and corporate policies. Compliance with these intricate regulations, mandates and policies is not an easy task. Maintaining ongoing compliance is even more difficult due to continuous changes, amendments and overlaps. Inability to comply with the regulations can lead to large penalties or even temporary suspension of operations. Hence compliance is about protecting an organization?s license to operate ? lack of compliance introduces a substantial financial and operational risk to an organization. As a result, compliance is very closely related to risk management.
	Full story

	The Next Generation of Systems for Compliance
	Companies are governed by a complex web of regulations, laws, voluntary codes, industry codes, and corporate policies. Compliance with these intricate regulations, mandates and policies is not an easy task. Maintaining ongoing compliance is even more difficult due to continuous changes, amendments and overlaps. Inability to comply with the regulations can lead to large penalties or even temporary suspension of operations. Hence compliance is about protecting an organization?s license to operate ? lack of compliance introduces a substantial financial and operational risk to an organization. As a result, compliance is very closely related to risk management.
	Full story

 Food for thought

Poor quality's effect on investors

A corporation?s shareholders hold its CEO responsible for personally investigating every idea, suggestion, inclination or notion that might lead to shareholder value. Attention to quality principles can increase value by:

	A sustained increase in revenues
	Ongoing reduction of operational expenses
	Consistent increases in efficiencies and effectiveness
	Any other combination of positive effects on the bottom line
- Quality Digest

Best form the past

Best Practices in CAPA

Supplier Chargebacks & Cost Recovery

Workplace Safety Compliance

IT Systems Validation for SOx and Regulatory Compliance

Quotes

"Quality in a product or service is not what the supplier puts in. It is what the customer gets out and is willing to pay for."
-	Peter F. Drucker, American Management Guru
"Professionalism means consistency of quality"
-	Frank Tyger

Click here to unsubscribe to this email.

This newsletter was sent by MetricStream
3000 Bridge Parkway, Redwood Shores, CA 94065