Why target adherence to Part 11 requirements?
The truth is that over the past few years Part 11 requirements, which were first established in 1997, haven't taken a tremendous amount of precedence during FDA inspections. This was partially due to the controversial nature of the creation of the Part 11 standards. However, over the passage of more than a decade and with many companies with significant amounts of additional IT resources, it's probably a good time for the FDA to determine how industry is currently choosing to implement Part 11 requirements.1 These audits may of course lead to additional changes in the regulatory documentation.
1. The information in this paragraph has been summarized primarily from the following content: http://www.gmp-compliance.org/eca_news_2119_6309,6310.html
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