Part 11 Presentation by Paul Motise of FDA

Presentation slides for “Part 11:Electronic Records; Electronic Signatures Answers to Frequently Asked Questions” given by Paul Motise in January of 1999. Paul transferred to the FDA’s Office of Regulatory Affairs from CDER during 1999 and is leading inspector training and enforcement efforts for this rule.

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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