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By Master Control
What’s The Status of Part 11?
Organizations regulated by the U.S. Food and Drug Administration (FDA) like pharmaceutical, biotechnology, medical device, and others continue to experience the peaks and valleys of complying with 21 CFR Part 11. While the regulation itself has not changed, industry and the technological environment certainly have. As a result, FDA has announced its intention to provide additional guidance regarding Part 11 compliance and enforcement in 2005.
Adhering to the Part 11 requirements is a significant undertaking for most companies. However, the effort expended in doing so has proven beneficial because it allows an organization to capitalize on current technologies to automate existing paper-based processes. In order to do this, companies not only must filter through all the technologies available to automate current paper-based processes, but must understand how to comply with Part 11 and execute their plan.
This paper provides an overview of 21 CFR Part 11 and how it came about, how it is affecting the industry, and how companies can ready themselves for compliance. At the conclusion, a description is provided detailing the MasterControl suite of quality management solutions and how it has been designed with all the features necessary to go beyond 21 CFR Part 11 requirements and regulations for “best practices” (CGxP).
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