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Quality & Compliance Newsletter - July 2004


From: 'Quality and Compliance'
Subject: Quality & Compliance Newsletter - July 2004
Date: Thu, 15 Jul 2004 16:05:26 -0700 (PDT)


 
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      July 2004  
 
Streamline your Systems Validation: A framework for FDA regulated companies
 

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. This white paper uses that FDA guidance as an input to define an "easy-to-implement" framework for systems validation. Finally the paper identifies a best practice which calls for IT organizations and software vendors to proactively audit their software development and implementation processes on an ongoing basis to identify and correct any systemic issues to lower the cost of compliance.

 
Read More ...
Incorporating Audits in your Operational framework
 

Many books and articles have been written about how to drive greater management and organizational output, only recently are managers being asked to think about how to incorporate "audits" as a management tool within their organizations. First of all, contrary to the belief, audit is not a responsibility of the internal or external auditors. It is the responsibility of business heads and managers who are running the operations of the company, on a day-to-day basis. How does one incorporate audit best practices within a management framework? Here are some simple examples of audits, which many large and small companies are using to enhance their compliance with internal and external regulations and mandates.

  Read More ...
 
  

 
"The ability to learn faster that your competitors may be the only sustainable competitive advantage."  
  - Arie P. de Geus
"Excellent firms don't believe in excellence, only in constant improvement and constant change."  
  - Tom Peters
"Detect and fix any problem in a production process at the lowest stage possible."  
  - Andrew S. Grove
"Goal setting has traditionally been based on past performance. This practice has tended to  perpetuate the sins of the past."  
  - Joseph M. Juran
Links to papers in the prior newsletter issues
 
Best Practices in CAPA
 
 
Workplace Safety Compliance
 
 
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