SoftwareCPR Partial 820.70(i) Training Manual$

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The pdf at the link provided contains a set of FDA reference documents and partial examples used in SoftwareCPR training courses on Validation of Production and Quality System Software and Part 11. This is just a partial set and other examples and checklists are tailored for each course offering.

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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

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