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Quality & Compliance - Building a Roadmap for 21CFR Part 11Compliance -


From: Quality and Compliance
Subject: Quality & Compliance - Building a Roadmap for 21CFR Part 11Compliance - Dec 2004
Date: Wed, 15 Dec 2004 08:59:08 -0600 (CST)

Inseights - MetricStream Inc.
  Quality and Compliance Insights From MetricStream Inc. is provided as a FREE service to Quality & Compliance professionals worldwide. Join the fastest growing 10,000+ network now!
 
  December 2004 | Volume Q&C INSIGHTS 12.2004  
 
Systems Validation for 21CFR Part 11  
   

21CFR part 11 requires validation for all systems that govern cGXP process - be it current Good Manufacturing Practices, Good Laboratory Practices, or Good Clinical Practices. Starting with comprehensive guidelines from FDA, this article explores "easy-to-implement" framework for systems validation and the best practices. Read More ...  
Best from the past

Supplier Chargebacks & Cost Recovery

Workplace Safety Compliance

IT Systems Validation for SOx and Regulatory Compliance


Industry Spotlight

According to AMR Research, 87% of the firms surveyed expect 2005 IT-related spending on compliance will equal or exceed 2004 spendings. The survey found:

- 68% expect budgets to increase year over year
- 19% plan on level spending in this category
- 13% estimate compliance expenses will fall

Compliance Online
Industry's first portal on quality and regulatory compliance.

Drawing a Roadmap  
The sticker shock of 21CFR Part 11 compliance to a company could range from $5 million to a hefty $400 million. This article delves into some issues in 21CFR part 11-system requirements, discusses a risk-based methodology to create a roadmap and identifies most popular first steps. Read More ...  
Cost of Poor Quality  
Is your company spending resources in manufacturing scraps? The quality department of a manufacturing company with annual sales of $250 million, calculated the total cost of repair, rework, scrap, service calls, warranty claims and write-offs to be in excess of 20% of their sales. So one day every week, the company spent its time manufacturing waste. Read More...  
Incorporating Audits in operations  
While Many books and articles have been written about how to drive greater management and organizational output, only recently managers are being asked to incorporate "audits" as a management tool. How does one incorporate audit best practices to manage day to day operations? Read More ...  
 

"The notion that medical device companies must maintain robust quality assurance systems to achieve regulatory compliance is not a new one. What is new, however, is the opportunity for medical device companies to transform regulatory compliance from a disparate set of cost center activities to a core element of their most strategic and profit-focused product initiatives."
 
    - Forbes IT Research  
"In many industries, competitive advantage is rapidly shifting to the management of suppliers, which can account for as much as 60 to 80 percent of manufacturing costs. Companies that effectively involve suppliers in their internal product development achieve a new strategic advantage."
 
    - The McKinsey Quarterly  
"Excellent firms don't believe in excellence, only in constant improvement and constant change."
 
    - Tom Peters  
Quality and Compliance Insights From MetricStream Inc. is provided as a FREE service to Quality & Compliance professionals worldwide. Join the fastest growing 10,000+ network now!
 
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