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February 28, 2003
This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The document at the link provided is a SoftwareCPR training aide on Part 11. It provides information and explanation of the Feb 2003 FDA redirection of its Part 11 regulation. It includes a summary of the areas of Part...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. A one page memory jogger for key sections of the Part 11 rule is at the link provided.  This is a SoftwareCPR training and auditing aide. This was updated Feb 2003 to highlight items for which FDA is changing...
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http://www.ispe.org/page.ww?name=Welcome+to+the+ISPE+GAMP+COP§ion=GAMP+COP
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Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

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  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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