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 Article Directory   Author   Marci L. Crane

Marci L. Crane  RSS Feed

Published Articles:12
Total Article Views:2,795 (unique visitors)
Total Article Rank:1 /5 (2 Ratings)

Marci L. Crane's Articles

Articles by: Marci L. Crane

Recent Articles

Web Document Management and a PDM Interface For Better CAD ..

Web document management may seem new to many medical device companies-it is certainly worth the consideration of all medical device manufacturers-but for those medical device companies that have ..
(June 20, 2008)
  • Currently nan/5
 | Computers-and-Technology/Software | Visitors: 232

Avoiding Corporate Risks and Hazards With Web Document ..

The loss of potential profitability is the horror of all horrors and the regret of all regrets-at least for business owners and other stake holders in the life science industries. Wouldn't they do ..
(July 13, 2008)
  • Currently nan/5
 | Computers-and-Technology/Software | Visitors: 170

The Power of Web Document Management in Highly Regulated ..

The life science environments are barraged with pressures: governmental regulations, recommended standards, and demands for higher quality and lower prices are nothing more than the dreaded Bermuda ..
(July 24, 2008)
  • Currently 1.00/5
 | Computers-and-Technology/Software | Visitors: 174

ISO Quality Systems - Measuring up to Technical Standards ..

ISO (International Organization for Standardization) quality systems, or systems that adhere to quality standards agreed upon by various ISO bodies, are quality systems that generally garner a high ..
(April 16, 2008)
  • Currently nan/5
 | Business/Management | Visitors: 273

Automated QSR Change Control for Medical Device Professionals ..

QSR change control, or change control processes based on the FDA's QSR regulation (21 CFR Part 820) is the ideal (or at least currently ideal) template for successful change control in the regulated ..
(April 04, 2008)
  • Currently 1.00/5
 | Computers-and-Technology/Software | Visitors: 412

Top 5 Ways to Write and Manage Quality System SOPs

From foundational SOPs (those SOPs that tell employees how to create other SOPs) to QA SOPs and from SOPs that determine analytical methodologies to safety SOPs, one would assume that writing SOPs ..
(March 28, 2008)
  • Currently nan/5
 | Business/Management | Visitors: 333

5 Benefits of a Simplified Change Control System that ..

Change control is an aspect of almost every regulated life science environment. Change control systems allow company employees to quickly observe anomalies that could be harmful not only for company ..
(March 27, 2008)
  • Currently nan/5
 | Business/Change-Management | Visitors: 196

Why a Six Sigma Based Quality System May be the Answer for ..

Life science companies experience no lack of quality system ideas, conversation, arguments, implementation methods, etc. After all, even the required systems of quality management such as the FDA's ..
(March 14, 2008)
  • Currently nan/5
 | Business/Management | Visitors: 264

Electronic Regulatory Compliance Training - A Combined ..

Compliance with the FDA, the ISO, the EMEA, CLIA and additional regulatory bodies has long been a habit for successful life science companies. However compliance-like the unfortunate cat-can be ..
(February 26, 2008)
  • Currently nan/5
 | Computers-and-Technology/Software | Visitors: 192

A Revolution (And A New Habit) In Quality System Process ..

A nail is driven out by another nail. Habit is overcome by habit. -Desiderius Erasmus In an age when life science companies stand to make millions or billions of dollars each year, making products ..
(January 04, 2008)
  • Currently nan/5
 | Business/Management | Visitors: 259

A Quality System that Collaborates With Technology

"I have always thought that the best way to find out what is right and what is not right, what should be done and what should not be done, is not to give a sermon, but to talk and discuss, and out of .
(December 21, 2007)
  • Currently nan/5
 | Computers-and-Technology/Software | Visitors: 164

An Introduction to CLIA Regulations and Facilitation Software ..

The CLIA regulations (Clinical Laboratory Improvement Amendments), like many regulations, were a response to less than desirable situations. Like Upton Sinclair's The Jungle (and other manifestations .
(December 04, 2007)
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 | Computers-and-Technology/Software | Visitors: 126