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October 14, 2010
At the October AAMI Software Validation Course the FDA instructor indicated that the device center is not participating in this and that the Drug center’s intent is to gather information on how companies handle electronic records and signatures and not to ramp up enforcement of Part 11.
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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:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

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