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Quality & Compliance Newsletter - May 2005

From: Quality and Compliance
Subject: Quality & Compliance Newsletter - May 2005
Date: Tue, 24 May 2005 03:36:57 -0500 (CDT)

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May 2005
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 The Quality & Compliance Newsletter
Systems Validation for 21CFR Part 11 Compliance
21CFR part 11 requires that all systems that govern any cGXP process - including Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Good Clinical Practices (GCPs), should be validated. FDA issued a very comprehensive guidance on systems validation in a document released in January 2002.  
Full story
Quality in an Outsourced Economy
Many companies across all industries have decided to focus on their core competencies and have outsourced manufacturing of some components, as well as specialty services to a partner, who may only be a driving distance away. Others have off-shored manufacturing to lower cost countries through their outsourced partners or by building captive manufacturing capacity in countries such as Malaysia, China, Taiwan and Thailand.
Full story
Corrective Action (CAPA) Systems at Innovative Companies
Increased regulatory pressures, the latest customer mandates and internal quality initiatives are requiring companies to take a proactive and automated approach to their corrective action process. Regulatory compliance requires organizations to capture all corrective action issues and track their corrective action process to completion.
Full story
Impact of Regulatory Compliance on Quality and Profits
Regulatory compliance by enterprises could result in a positive impact on quality of the product and services that they generate. This could imply that the results of compliance can be quantified into direct economic value for the complying enterprises. Although this is not a tested hypothesis no one would dispute the fact that a significant body of regulations today, attempts to raise the quality of products to benefit (or protect) the consumers.
Full story
 Food for thought
Sarbanes Oxley Drives Up Large Companies' Audit Costs by $1.4 Billion  
With the latest figures reported, as of April 27, 2005, a total of 633 Fortune 1000 firms have reportedly paid more than $3.6 billion for their 2004 audits, compared to $2.2 billion in 2003, according to accounting professors Susan Eldridge and Burch Kealey, who helped develop an automatic text-mining and data extraction technique that makes hundreds of hours of data-collection manageable.

Key industries had the following audit fee increases:
Drug companies, up 90 percent
Banks, up 65 percent
Utilities, up 105 percent
Insurance, up 72 percent
Energy, up 100 percent
Retail, up 180 percent
- Insurance Journal
Best from the past
Best Practices in CAPA
Supplier Chargebacks & Cost Recovery
Workplace Safety Compliance
IT Systems Validation for SOx and Regulatory Compliance
The Four Absolutes of Quality Management:
  • Quality has to be defined as conformance to requirements, not as goodness.
  • The system for causing quality is prevention, not appraisal.
  • The performance standard must be zero defects, not "that's close enough."
  • The measurement of quality is the process of nonconformance, not indexes
    - Philip B Crosby, Quality Without Tears: The Art of Hassle-Free Management  
    "Quality in a service or product is not what you put into it. It is what the customer gets out of it."  
    - Peter Drucker  
    ?You seldom improve quality by cutting costs, but you can often cut costs by improving quality.?  
    - Karl Albrecht  
    - FDA outlines new risk-based strategy on GMP
    - Keeping IT Secure and Complying with SOX
    - Strict chemical rules pend before EU
    - Hackett Study to 'Uncover True Cost' of SOX
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